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1.
Trials ; 22(1): 8, 2021 Jan 06.
Artigo em Inglês | MEDLINE | ID: mdl-33407804

RESUMO

OBJECTIVES: The primary objective is to determine which of two interventions: 1) an eight week, online, home-based, supervised, group rehabilitation programme (REGAIN); or 2) a single online session of advice (best-practice usual care); is the most clinically and cost-effective treatment for people with ongoing COVID-19 sequelae more than three months after hospital discharge. TRIAL DESIGN: Multi-centre, 2-arm (1:1 ratio) parallel group, randomised controlled trial with embedded process evaluation and health economic evaluation. PARTICIPANTS: Adults with ongoing COVID-19 sequelae more than three months after hospital discharge Inclusion criteria: 1) Adults ≥18 years; 2) ≥ 3 months after any hospital discharge related to COVID-19 infection, regardless of need for critical care or ventilatory support; 3) substantial (as defined by the participant) COVID-19 related physical and/or mental health problems; 4) access to, and able/supported to use email and internet audio/video; 4) able to provide informed consent; 5) able to understand spoken and written English, Bengali, Gujarati, Urdu, Punjabi or Mandarin, themselves or supported by family/friends. EXCLUSION CRITERIA: 1) exercise contraindicated; 2) severe mental health problems preventing engagement; 3) previous randomisation in the present study; 4) already engaged in, or planning to engage in an alternative NHS rehabilitation programme in the next 12 weeks; 5) a member of the same household previously randomised in the present study. INTERVENTION AND COMPARATOR: Intervention 1: The Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN (REGAIN) programme: an eight week, online, home-based, supervised, group rehabilitation programme. Intervention 2: A thirty-minute, on-line, one-to-one consultation with a REGAIN practitioner (best-practice usual care). MAIN OUTCOMES: The primary outcome is health-related quality of life (HRQoL) - PROMIS® 29+2 Profile v2.1 (PROPr) - measured at three months post-randomisation. Secondary outcomes include dyspnoea, cognitive function, health utility, physical activity participation, post-traumatic stress disorder (PTSD) symptom severity, depressive and anxiety symptoms, work status, health and social care resource use, death - measured at three, six and 12 months post-randomisation. RANDOMISATION: Participants will be randomised to best practice usual care or the REGAIN programme on a 1:1.03 basis using a computer-generated randomisation sequence, performed by minimisation and stratified by age, level of hospital care, and case level mental health symptomatology. Once consent and baseline questionnaires have been completed by the participant online at home, randomisation will be performed automatically by a bespoke web-based system. BLINDING (MASKING): To ensure allocation concealment from both participant and REGAIN practitioner at baseline, randomisation will be performed only after the baseline questionnaires have been completed online at home by the participant. After randomisation has been performed, participants and REGAIN practitioners cannot be blind to group allocation. Follow-up outcome assessments will be completed by participants online at home. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): A total of 535 participants will be randomised: 263 to the best-practice usual care arm, and 272 participants to the REGAIN programme arm. TRIAL STATUS: Current protocol: Version 3.0 (27th October 2020) Recruitment will begin in December 2020 and is anticipated to complete by September 2021. TRIAL REGISTRATION: ISRCTN:11466448 , 23rd November 2020 FULL PROTOCOL: The full protocol Version 3.0 (27th October 2020) is attached as an additional file, accessible from the Trials website (Additional file 1). In the interests of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines.


Assuntos
/reabilitação , Terapia por Exercício/métodos , Intervenção Baseada em Internet/economia , Sistemas de Apoio Psicossocial , Encaminhamento e Consulta/economia , Adulto , /psicologia , Análise Custo-Benefício , Terapia por Exercício/economia , Feminino , Humanos , Masculino , Estudos Multicêntricos como Assunto , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Índice de Gravidade de Doença , Resultado do Tratamento , Reino Unido
2.
Phys Ther ; 100(8): 1278-1288, 2020 08 12.
Artigo em Inglês | MEDLINE | ID: mdl-32372072

RESUMO

OBJECTIVE: The purpose of this study was to describe the process and cost of delivering a physical therapist-guided synchronous telehealth exercise program appropriate for older adults with functional limitations. Such programs may help alleviate some of the detrimental impacts of social distancing and quarantine on older adults at-risk of decline. METHODS: Data were derived from the feasibility arm of a parent study, which piloted the telehealth program for 36 sessions with 1 participant. The steps involved in each phase (ie, development, delivery) were documented, along with participant and program provider considerations for each step. Time-driven activity-based costing was used to track all costs over the course of the study. Costs were categorized as program development or delivery and estimated per session and per participant. RESULTS: A list of the steps and the participant and provider considerations involved in developing and delivering a synchronous telehealth exercise program for older adults with functional impairments was developed. Resources used, fixed and variable costs, per-session cost estimates, and total cost per person were reported. Two potential measures of the "value proposition" of this type of intervention were also reported. Per-session cost of $158 appeared to be a feasible business case, especially if the physical therapist to trained assistant personnel mix could be improved. CONCLUSIONS: The findings provide insight into the process and costs of developing and delivering telehealth exercise programs for older adults with functional impairments. The information presented may provide a "blue print" for developing and implementing new telehealth programs or for transitioning in-person services to telehealth delivery during periods of social distancing and quarantine. IMPACT: As movement experts, physical therapists are uniquely positioned to play an important role in the current COVID-19 pandemic and to help individuals who are at risk of functional decline during periods of social distancing and quarantine. Lessons learned from this study's experience can provide guidance on the process and cost of developing and delivering a telehealth exercise program for older adults with functional impairments. The findings also can inform new telehealth programs, as well as assist in transitioning in-person care to a telehealth format in response to the COVID-19 pandemic.


Assuntos
Infecções por Coronavirus , Pessoas com Deficiência/reabilitação , Terapia por Exercício/economia , Serviços de Assistência Domiciliar/economia , Pandemias , Modalidades de Fisioterapia/economia , Pneumonia Viral , Telemedicina/economia , Atividades Cotidianas , Idoso , Dor Crônica/terapia , Análise Custo-Benefício , Feminino , Humanos , Masculino , Projetos Piloto , Telemedicina/métodos
3.
Trials ; 21(1): 46, 2020 Jan 08.
Artigo em Inglês | MEDLINE | ID: mdl-31915043

RESUMO

BACKGROUND: Falls are two to four times more frequent amongst older adults living in long-term care (LTC) than community-dwelling older adults and have deleterious consequences. It is hypothesised that a progressive exercise program targeting balance and strength will reduce fall rates when compared to a seated exercise program and do so cost effectively. METHODS/DESIGN: This is a single blind, parallel-group, randomised controlled trial with blinded assessment of outcome and intention-to-treat analysis. LTC residents (age ≥ 65 years) will be recruited from LTC facilities in New Zealand. Participants (n = 528 total, with a 1:1 allocation ratio) will be randomly assigned to either a novel exercise program (Staying UpRight), comprising strength and balance exercises designed specifically for LTC and acceptable to people with dementia (intervention group), or a seated exercise program (control group). The intervention and control group classes will be delivered for 1 h twice weekly over 1 year. The primary outcome is rate of falls (per 1000 person years) within the intervention period. Secondary outcomes will be risk of falling (the proportion of fallers per group), fall rate relative to activity exposure, hospitalisation for fall-related injury, change in gait variability, volume and patterns of ambulatory activity and change in physical performance assessed at baseline and after 6 and 12 months. Cost-effectiveness will be examined using intervention and health service costs. The trial commenced recruitment on 30 November 2018. DISCUSSION: This study evaluates the efficacy and cost-effectiveness of a progressive strength and balance exercise program for aged care residents to reduce falls. The outcomes will aid development of evidenced-based exercise programmes for this vulnerable population. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12618001827224. Registered on 9 November 2018. Universal trial number U1111-1217-7148.


Assuntos
Acidentes por Quedas/prevenção & controle , Terapia por Exercício/organização & administração , Assistência de Longa Duração/organização & administração , Qualidade de Vida , Acidentes por Quedas/estatística & dados numéricos , Idoso , Análise Custo-Benefício , Terapia por Exercício/economia , Terapia por Exercício/métodos , Feminino , Marcha/fisiologia , Hospitalização/estatística & dados numéricos , Humanos , Assistência de Longa Duração/economia , Assistência de Longa Duração/métodos , Masculino , Desempenho Físico Funcional , Equilíbrio Postural/fisiologia , Avaliação de Programas e Projetos de Saúde , Ensaios Clínicos Controlados Aleatórios como Assunto , Método Simples-Cego , Resultado do Tratamento , Populações Vulneráveis
4.
Artigo em Inglês | MEDLINE | ID: mdl-31973115

RESUMO

BACKGROUND: Women with fibromyalgia (FM) have 2.5 falls per year compared to the 0.5 falls in people without FM. This fact poses a significant health expense. Square Stepping Exercise (SSE) is a balance training system that has been shown to be effective in preventing falls in the elderly. However, there are neither studies in people with FM nor studies that apply SSE through video-conferencing (Tele-SSE). The objectives of this project are 1) to investigate the applicability, safety, decrease in the number of falls, and incremental cost-effectiveness ratio of prevention of falls program through Tele-SSE in women with FM, and 2) to study the transfer of obtained results to the public and private socio-health economy of Extremadura. Methods/Design: A randomized controlled trial with experimental (Tele-SSE) and control (usual treatment) groups will be carried out. The application of Tele-SSE will be performed for 12 months (three times per week) and one additional follow-up month after the intervention. A focus group including agents to identify key points to transfer the findings to the public and private sectors in Extremadura. One-hundred and eighteen women with FM will be recruited and randomly distributed into the two groups: Experimental (Tele-SSE; n = 59) and control group (Usual care; n = 59). Primary outcome measures will be: 1) Applicability; 2) safety; 3) annual number of falls; and 4) incremental cost-effectiveness ratio. Secondary outcomes will be: 1) Balance; 2) fear of falling; 3) socio-demographic and clinical information; 4) body composition; 5) physical fitness; 6) physical activity and sedentary behavior; 7) quality of life-related to health, mental health, and positive health; 8) pain; 9) disability level; 10) cognitive aspects; and 11) depressive symptoms. Regarding the focus group, the acceptability of the Tele-SSE will be evaluated in social-sanitary agents and will include Tele-SSE in their services offer. A statistical analysis will be carried out by treatment intention and protocol. In addition, a cost-effectiveness analysis from the perspective of the health system will be performed. DISCUSSION: This project aims to improve the efficiency and equity of physical therapy services based on tele-exercise in preventing falls in people with FM. Furthermore, orientations will be given in order to transfer the obtained findings into the social-sanitary system and market.


Assuntos
Acidentes por Quedas/prevenção & controle , Terapia por Exercício/métodos , Fibromialgia/reabilitação , Telemedicina , Idoso , Análise Custo-Benefício , Exercício Físico , Terapia por Exercício/economia , Medo , Feminino , Humanos , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto
5.
Clin Ther ; 42(1): 60-75.e7, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31959413

RESUMO

PURPOSE: The aim of the present study was to assess, by using a cost-benefit analysis, the net monetary benefit (NMB) of bariatric surgery compared with diet (including physical exercise) for obese patients, from both an Italian payer perspective and the broader societal perspective. METHODS: The study considered the following groups of patients: (1) patients with a body mass index (BMI) ≥40 kg/m2 without complications + patients with BMI ≥35 kg/m2 with complications; (2) patients with BMI ≥35 kg/m2 and diabetes; and (3) patients with BMI ranging from 30 to 35 kg/m2 and diabetes. A Markov model was developed to project the lifetime health outcomes (life years and quality-adjusted life years [QALYs]) and costs associated with bariatric surgery and diet for the considered groups of patients. The clinical effectiveness of each strategy was based on the likelihood of experiencing cardiovascular events or events related to the presence of diabetes. Data on clinical effectiveness, quality of life, productivity losses, and out-of-pocket costs were mainly derived from the literature; direct costs were obtained from official tariffs or the literature. Different scenarios were considered for the analyses in addition to the base case. According to both perspectives considered, the NMB was calculated by first assuming a willingness-to-pay threshold (30,000€ per QALY), then converting health benefits (QALYs) into the common monetary metric (ie, the euro). NMB was calculated as follows: (incremental benefit × willingness-to-pay - incremental cost). FINDINGS: For all the scenarios and groups of patients considered, the NMB of bariatric surgery versus diet, on a lifetime horizon, from the payer perspective was positive and ranged from 54,647€ to 122,960€; it varied between 141,192€ and 380,286€ from the societal perspective. In the former case, the NMB turns positive after 3-4 years, indicating that bariatric surgery may be a worthy investment also in the short run for the National Health Service; in the latter case, for a time horizon longer than 2-3 years, the surgical option begins to show advantages for the whole society. IMPLICATIONS: Despite its defined cost-effectiveness, bariatric surgery is under-diffused because the initial investment for the technology is often considered a barrier. The cost-benefit analysis showed that bariatric surgery, compared with diet, may be a worthwhile technology for obese patients in Italy from both a payer perspective and the broader societal perspective.


Assuntos
Cirurgia Bariátrica/economia , Diabetes Mellitus/terapia , Dieta/economia , Terapia por Exercício/economia , Modelos Econômicos , Obesidade/terapia , Adulto , Índice de Massa Corporal , Análise Custo-Benefício , Diabetes Mellitus/economia , Feminino , Humanos , Masculino , Obesidade/economia , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida
6.
Circ Cardiovasc Interv ; 13(1): e008450, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31937137

RESUMO

BACKGROUND: The long-term benefit of revascularization for intermittent claudication is poorly understood. The aim of this study was to investigate the long-term effectiveness and cost-effectiveness compared with a noninvasive approach. METHODS: The IRONIC trial (Invasive Revascularization or Not in Intermittent Claudication) randomized patients with mild-to-severe intermittent claudication to either revascularization + best medical therapy + structured exercise therapy (the revascularization group) or best medical therapy + structured exercise therapy (the nonrevascularization group). The health-related quality of life short form 36 questionnaire was primary outcome and disease-specific health-related quality of life (vascular quality of life questionnaire) and treadmill walking distances were secondary end points. Health-related quality of life has previously been reported superior in the revascularization group at 1- and 2-year follow-up. In this study, the 5-year results were determined. The cost-effectiveness of the treatment options was analyzed from a payer/healthcare standpoint. RESULTS: Altogether, 158 patients were randomized in a 1:1 ratio. Regarding the primary end point, no intergroup differences were observed for the short form 36 sum or domain scores from baseline to 5 years, except for the short form 36 role emotional domain score, with greater improvement in the nonrevascularization group (n=116, P=0.007). No intergroup differences were observed in the vascular quality of life questionnaire total and domain scores (n=116, NS) or in treadmill walking distances (n=91, NS). A revascularization strategy resulted in almost twice the cost per patient compared with a noninvasive treatment approach ($13 098 versus $6965, P=0.02). CONCLUSIONS: After 5 years of follow-up, a revascularization strategy had lost its early benefit and did not result in any long-term improvement in health-related quality of life or walking capacity compared to a noninvasive treatment strategy. Revascularization was not a cost-effective treatment option from a payer/healthcare point of view. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01219842.


Assuntos
Fármacos Cardiovasculares/uso terapêutico , Terapia por Exercício , Tolerância ao Exercício , Claudicação Intermitente/terapia , Doença Arterial Periférica/terapia , Procedimentos Cirúrgicos Vasculares , Idoso , Fármacos Cardiovasculares/efeitos adversos , Fármacos Cardiovasculares/economia , Terapia Combinada , Análise Custo-Benefício , Terapia por Exercício/efeitos adversos , Terapia por Exercício/economia , Feminino , Custos de Cuidados de Saúde , Nível de Saúde , Humanos , Claudicação Intermitente/diagnóstico , Claudicação Intermitente/economia , Claudicação Intermitente/fisiopatologia , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/economia , Doença Arterial Periférica/fisiopatologia , Estudos Prospectivos , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida , Recuperação de Função Fisiológica , Suécia , Fatores de Tempo , Resultado do Tratamento , Procedimentos Cirúrgicos Vasculares/efeitos adversos , Procedimentos Cirúrgicos Vasculares/economia , Caminhada
7.
BMC Musculoskelet Disord ; 21(1): 10, 2020 Jan 06.
Artigo em Inglês | MEDLINE | ID: mdl-31906904

RESUMO

BACKGROUND: First-line treatment for hip and knee osteoarthritis (OA) including education and supervised exercises, delivered as a self-management program, is considered one of the mainstays in OA treatment. However, the socioeconomic profile of the population that utilizes first-line treatment for hip and knee OA is unclear. The aim of this study was to describe the socioeconomic status (SES) of a population referred to a self-management program for OA, in comparison with that of the general Swedish population. METHODS: This is a cross-sectional study including 72,069 patients with hip or knee OA enrolled in the National Quality Register for Better management of patients with Osteoarthritis (BOA) between 2008 and 2016, and registered before participation in a structured OA self-management program. A reference cohort (n = 216,207) was selected from the general Swedish population by one-to-three matching by year of birth, sex and residence. Residential municipality, country of birth, marital status, family type, educational level, employment, occupation, disposable income and sick leave were analyzed. RESULTS: The BOA population had higher educational level than the reference group, both regarding patients with hip OA (77.5% vs 70% with ≥10 years of education), and with knee OA (77% vs 72% with ≥10 years of education). Their average disposable income was higher (median [IQR] in Euro (€), for hip €17,442 [10,478] vs €15,998 [10,659], for knee €17,794 [10,574] vs €16,578 [11,221]). Of those who worked, 46% of patients with hip OA and 45% of the reference group had a blue-collar occupation. The corresponding numbers for knee OA were 51 and 44% respectively. Sick leave was higher among those with hip and knee OA (26%) than those in the reference groups (13% vs 12%). CONCLUSIONS: The consistently higher SES in the BOA population compared with the general population indicates that this self-management program for OA may not reach the more socioeconomically disadvantaged groups, who are often those with a higher disease burden.


Assuntos
Terapia por Exercício , Acesso aos Serviços de Saúde , Osteoartrite do Quadril/terapia , Osteoartrite do Joelho/terapia , Educação de Pacientes como Assunto , Autogestão , Classe Social , Determinantes Sociais da Saúde , Idoso , Estudos de Casos e Controles , Estudos Transversais , Escolaridade , Terapia por Exercício/economia , Feminino , Acesso aos Serviços de Saúde/economia , Humanos , Renda , Masculino , Pessoa de Meia-Idade , Ocupações , Osteoartrite do Quadril/economia , Osteoartrite do Quadril/epidemiologia , Osteoartrite do Joelho/economia , Osteoartrite do Joelho/epidemiologia , Educação de Pacientes como Assunto/economia , Sistema de Registros , Autogestão/economia , Suécia/epidemiologia
8.
J Vasc Surg ; 71(5): 1702-1707, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-31699514

RESUMO

BACKGROUND: Supervised exercise therapy (SET) is an inexpensive, low-risk, and effective option when compared with invasive therapies for the treatment of patients with peripheral artery disease (PAD) and intermittent claudication. Randomized, controlled trials have demonstrated the benefits of SET in improving maximum walking distance in intermittent claudication patients, and society guidelines recommend SET as first-line therapy. In 2017, the Centers for Medicare & Medicaid Services (CMS) added coverage of SET. We aimed to evaluate the availability and use of SET programs, determine the awareness of SET CMS coverage in the United States, and gauge the academic interest in SET in the vascular community. METHODS: An eight-question online survey regarding SET coverage, reimbursement, barriers to prescription, and SET use was sent to 900 vascular surgeons, cardiologists, and vascular medicine physicians across the United States. The most recent 2-year programs for the Vascular Annual Meeting, Midwestern Vascular Society, Eastern Vascular Society, and Western Vascular Society were reviewed to identify SET-related abstracts and gauge academic interest and awareness for SET within the vascular surgery community. RESULTS: We received 135 physician responses (15%) to the survey. All 50 states were represented. The majority of responders (54%) stated that there was no SET program at their facility, and 5% did not know if there was a SET program available. Of those who did have a SET program available, 81% were associated with cardiac rehabilitation and 19% had a PAD-specific program. A significant number of physicians (49%) had never referred a patient for SET. Twenty-six percent were not aware that CMS covered SET sessions. Of the physicians who were aware of CMS reimbursement, 36% had never referred a patient to a SET program. Of all surveyed, 98% indicated they would refer patients to a SET program if one was available. Top barriers to use of a SET program included (1) no SET center availability and (2) significant cost or travel expense to the patient. A review of major vascular surgery meeting programs for the last 2 years yielded no identification of a SET-related abstract. CONCLUSIONS: There is a lack of both availability and use of SET for patients with PAD with claudication, despite guideline recommendations and CMS reimbursement for SET sessions in the United States. When SET is offered, it is typically through cardiac rehabilitation programs which is not focused on PAD. Travel distance, lack of SET program availability, and low reimbursement rates are primary areas that could be addressed to improve use.


Assuntos
Terapia por Exercício/métodos , Claudicação Intermitente/terapia , Doenças Vasculares Periféricas/terapia , Idoso , Terapia por Exercício/economia , Feminino , Acesso aos Serviços de Saúde , Humanos , Masculino , Medicare/economia , Inquéritos e Questionários , Estados Unidos
9.
Physiother Res Int ; 25(2): e1819, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-31778291

RESUMO

OBJECTIVES: Knee osteoarthritis (OA) is characterized by its heterogeneity, with large differences in clinical characteristics between patients. Therefore, a stratified approach to exercise therapy, whereby patients are allocated to homogeneous subgroups and receive a stratified, subgroup-specific intervention, can be expected to optimize current clinical effects. Recently, we developed and pilot tested a model of stratified exercise therapy based on clinically relevant subgroups of knee OA patients that we previously identified. Based on the promising results, it is timely to evaluate the (cost-)effectiveness of stratified exercise therapy compared with usual, "nonstratified" exercise therapy. METHODS: A pragmatic cluster randomized controlled trial including economic and process evaluation, comparing stratified exercise therapy with usual care by physical therapists (PTs) in primary care, in a total of 408 patients with clinically diagnosed knee OA. Eligible physical therapy practices are randomized in a 1:2 ratio to provide the experimental (in 204 patients) or control intervention (in 204 patients), respectively. The experimental intervention is a model of stratified exercise therapy consisting of (a) a stratification algorithm that allocates patients to a "high muscle strength subgroup," "low muscle strength subgroup," or "obesity subgroup" and (b) subgroup-specific, protocolized exercise therapy (with an additional dietary intervention from a dietician for the obesity subgroup only). The control intervention will be usual best practice by PTs (i.e., nonstratified exercise therapy). Our primary outcome measures are knee pain severity (Numeric Rating Scale) and physical functioning (Knee Injury and Osteoarthritis Outcome Score subscale daily living). Measurements will be performed at baseline, 3-month (primary endpoint), 6-month (questionnaires only), and 12-month follow-up, with an additional cost questionnaire at 9 months. Intention-to-treat, multilevel, regression analysis comparing stratified versus usual care will be performed. CONCLUSION: This study will demonstrate whether stratified care provided by primary care PTs is effective and cost-effective compared with usual best practice from PTs.


Assuntos
Terapia por Exercício/economia , Osteoartrite do Joelho/economia , Osteoartrite do Joelho/terapia , Medição da Dor/economia , Análise Custo-Benefício , Terapia por Exercício/métodos , Feminino , Custos de Cuidados de Saúde , Humanos , Masculino , Manipulações Musculoesqueléticas/economia , Medição da Dor/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/economia , Treinamento de Resistência/economia , Resultado do Tratamento
10.
Am J Phys Med Rehabil ; 99(3): 233-240, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-31361623

RESUMO

OBJECTIVE: The cost-effectiveness of exercise interventions in lung cancer survivors is unknown. We performed a model-based cost-effectiveness analysis of an exercise intervention in lung cancer survivors. DESIGN: We used Markov modeling to simulate the impact of the Lifestyle Interventions and Independence for Elders exercise intervention compared with usual care for stage I-IIIA lung cancer survivors after curative-intent treatment. We calculated and considered incremental cost-effectiveness ratios of less than US $100,000/quality-adjusted life-year as cost-effective and assessed model uncertainty using sensitivity analyses. RESULTS: The base-case model showed that the Lifestyle Interventions and Independence for Elders exercise program would increase overall cost by US $4740 and effectiveness by 0.06 quality-adjusted life-years compared with usual care and have an incremental cost-effectiveness ratio of US $79,504/quality-adjusted life-year. The model was most sensitive to the cost of the exercise program, probability of increasing exercise, and utility benefit related to exercise. At a willingness-to-pay threshold of US $100,000/quality-adjusted life-year, Lifestyle Interventions and Independence for Elders had a 71% probability of being cost-effective compared with 27% for usual care. When we included opportunity costs, Lifestyle Interventions and Independence for Elders had an incremental cost-effectiveness ratio of US $179,774/quality-adjusted life-year, exceeding the cost-effectiveness threshold. CONCLUSIONS: A simulation of the Lifestyle Interventions and Independence for Elders exercise intervention in lung cancer survivors demonstrates cost-effectiveness from an organization but not societal perspective. A similar exercise program for lung cancer survivors may be cost-effective.


Assuntos
Sobreviventes de Câncer , Análise Custo-Benefício , Terapia por Exercício/economia , Neoplasias Pulmonares/economia , Neoplasias Pulmonares/terapia , Idoso , Teste de Esforço , Feminino , Avaliação Geriátrica , Humanos , Estilo de Vida , Masculino , Cadeias de Markov , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida
11.
Kinesiologia ; 39(1): 14-20, 2020. tab
Artigo em Espanhol | LILACS | ID: biblio-1123338

RESUMO

OBJETIVO: Determinar las razones de la escasa derivación, acceso, y adherencia a programas de ejercicio supervisado (PES) en pacientes con claudicación intermitente (CI) y la costo-efectividad de estos programas a nivel Internacional. MÉTODOS: Se utilizaron las fuentes de datos de PubMed y ScienceDirect. Se incluyeron revisiones con acceso completo, publicados desde el año 2010, que incluían como mínimo 3 artículos de tipo cuantitativo. RESULTADOS: Se incluyeron 5 Revisiones asociadas a los resultados del ejercicio supervisado, su costo-efectividad, la baja derivación y adherencia a PES de los pacientes con CI. En cuanto a la costo-efectividad los resultados indican que los PES fueron rentables con un ICER de £711 a £1.608 por QALY ganado al compararlos con ejercicio no supervisado, y al compararlos con la cirugía de revascularización (CR) no hay diferencia significativa en QALY ganados, sin embargo, el costo por QALY fue €381.694 más alto para la CR. Por otro lado, las principales razones de la subutilización de los PES, es que los pacientes se resisten a asistir, ya que involucra un esfuerzo y responsabilidad, además de tener problemas de reembolso, teniendo baja adherencia. Sumado a esto, el interés personal de los médicos por realizar intervenciones que involucran pago por servicio produce una baja derivación (45% de cirujanos en Europa refieren menos del 50% de sus pacientes). CONCLUSIÓN: Las principales dificultades para adoptar los PES serían una carencia en la destinación de recursos, falta de centros, dificultad de traslado, falta de tiempo, o de interés por parte de los pacientes, además de incentivos financieros a otras alternativas de tratamiento por sobre PES lo que limita su derivación.


OBJECTIVE: To determine the reasons for the limited derivation, access and adherence to supervised exercise programs (SEP) in patients with intermittent claudication (IC) and the cost-effectiveness of these programs internationally. METHODS: PubMed and ScienceDirect databases were searched. Revisions with full access, published since 2010, which included at least 3 quantitative type articles. RESULTS: 5 reviews were included, these were associated with the results of the supervised exercise, its cost-effectiveness, the low referral and adherence to programs of patients with IC. Regarding cost-effectiveness, the results indicated that SEP were more cost-effective with an ICER of £711 to £1.608 per QALY gained when compared with unsupervised exercise, and that when compared with revascularization surgery (RC) there was no significant difference in QALYs, however the cost per QALY was € 381.694 higher for the RC. On the other hand, the main reasons for the underutilization of SEP are that patients are reluctant to attend, since it involves effort and responsibility, in addition to having reimbursement problems, therefore having low adherence. Added to this, the personal interest of doctors in performing interventions that involve payment for service produce a low referral (45% of surgeons in Europe refer less than 50% of their patients) CONCLUSION: The main difficulties in adopting the SEP would be a lack in the allocation of resources, lack of centers, difficulty of transportation, lack of time or lack of interest from patients, in addition to financial incentives to other treatment alternatives over SEP, which limits their referral.


Assuntos
Humanos , Terapia Diretamente Observada/economia , Terapia Diretamente Observada/estatística & dados numéricos , Terapia por Exercício/economia , Claudicação Intermitente/terapia , Encaminhamento e Consulta/estatística & dados numéricos , Cooperação do Paciente , Análise Custo-Benefício , Terapia por Exercício/métodos , Terapia por Exercício/estatística & dados numéricos , Cooperação e Adesão ao Tratamento , Mau Uso de Serviços de Saúde , Claudicação Intermitente/reabilitação
12.
BMJ Open Respir Res ; 6(1): e000500, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31803476

RESUMO

Background: The primary aim was to determine the healthcare utilisation benefits including respiratory-related hospital admissions, hospital admission days and emergency department presentations in the 0-12 and 12-24 months postpulmonary rehabilitation compared with the 12 months preprogramme. Methods: An observational, data-linkage design of 11 standardised pulmonary rehabilitation programmes were used. All programmes were 8 weeks in duration with two supervised exercise sessions per week and were required to use the national pulmonary rehabilitation recommendations with regard to programme organisation, exercise training guidelines and multidisciplinary education. For each participant with chronic obstructive pulmonary disease (COPD), healthcare utilisation data were collected for the 12 months preprogramme and 24 months postprogramme. Results: 426 participants (231 males, FEV149.3 (19.6) % predicted) were studied. The number of respiratory admissions/participant/year decreased from 0.7 (1.1) in the 12 months preprogramme to 0.5 (1.9) in the 12 months postprogramme, p=0.083; but increased in the 12-24 months postprogramme to 1.0 (2.3), p<0.001. The hospital days/participant/year improved from 4.0 (7.8) days in the 12 months preprogramme to 2.5 (8.5) days in the 12 months postprogramme, p<0.001; but increased in the 12-24 months postprogramme to 6.1 (16.6) days, p=0.004. The emergency department presentations/participant/year improved from 1.15 (1.75) in the 12 months preprogramme to 0.9 (1.8) in the 12 months postprogramme, p=0.003; but increased in the 12-24 months postprogramme to 2.0 (3.3), p<0.001. Conclusion: Pulmonary rehabilitation significantly improves hospital days and emergency department presentations in the first 12 months postprogramme. Healthcare utilisation benefits in the second 12 months are less clear.


Assuntos
Análise Custo-Benefício , Terapia por Exercício/organização & administração , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Doença Pulmonar Obstrutiva Crônica/terapia , Idoso , Serviço Hospitalar de Emergência/economia , Serviço Hospitalar de Emergência/estatística & dados numéricos , Terapia por Exercício/economia , Terapia por Exercício/normas , Terapia por Exercício/estatística & dados numéricos , Feminino , Volume Expiratório Forçado , Humanos , Tempo de Internação/economia , Tempo de Internação/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Admissão do Paciente/economia , Admissão do Paciente/estatística & dados numéricos , Educação de Pacientes como Assunto/economia , Educação de Pacientes como Assunto/organização & administração , Educação de Pacientes como Assunto/estatística & dados numéricos , Guias de Prática Clínica como Assunto , Avaliação de Programas e Projetos de Saúde , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Doença Pulmonar Obstrutiva Crônica/economia , Qualidade de Vida , Fatores de Tempo , Resultado do Tratamento
13.
Aust J Rural Health ; 27(6): 514-519, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31713303

RESUMO

OBJECTIVE: To assess temporal trends in service provision by Accredited Exercise Physiologists based on remoteness classification using Australian Bureau of Statistics remoteness classifications of Major Cities, Inner Regional, Outer Regional, Remote and Very Remote. DESIGN AND PARTICIPANTS: Cross-sectional analysis of publicly available Medicare Benefits Schedule datasets, for Medicare item number 10953 from 2012-2013 to 2016-2017. MAIN OUTCOME MEASURE(S): Number of claims, benefits paid, fees charges and number of providers for Medicare item number 10953. RESULTS: Accredited Exercise Physiologist service delivery demonstrates growth across all areas of remoteness classification. Rebates and fees mirror service delivery trends. The rate of service growth was significantly greater in Major Cities compared with all other remoteness classifications. Provider numbers show a steady increase from 2012-2013 to 2016-2017 but number remains higher in Major Cities compared with all other remoteness locations. CONCLUSION: Given the high proportion of chronic and complex illness in rural and remote areas, and the limited access to allied health care services, we propose more needs to be done to position Accredited Exercise Physiologists in these regions of increasing need. These findings have implications for future development of the Accredited Exercise Physiologist profession.


Assuntos
Terapia por Exercício/economia , Terapia por Exercício/tendências , Serviços de Saúde Rural , Austrália , Estudos Transversais , Bases de Dados Factuais , Honorários e Preços/estatística & dados numéricos , Acesso aos Serviços de Saúde , Humanos , Cobertura do Seguro/economia , Seguro Saúde
14.
Medicine (Baltimore) ; 98(41): e17289, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31593081

RESUMO

INTRODUCTION: Fibromyalgia (FM) is a chronic condition characterized by chronic pain, fatigue and loss of function which significantly impairs quality of life. Although treatment of FM remains disputed, some studies point at the efficacy of interdisciplinary therapy. This study aims to analyze the effectiveness, cost-utility and benefits of a multicomponent therapy on quality of life (main variable), functional impact, mood and pain in people suffering from FM that attend primary care centers (PCCs) of the Catalan Institute of Health (ICS). METHODS AND ANALYSIS: A 2-phase, mixed methods study has been designed following Medical Research Council guidance. Phase 1: Pragmatic randomized clinical trial with patients diagnosed with FM that attend one of the 11 PCCs of the ICS Gerència Territorial Terres de l'Ebre. We estimate a total sample of 336 patients. The control group will receive usual clinical care, while the multicomponent therapy group (MT group) will receive usual clinical care plus group therapy (consisting of health education, exercise and cognitive-behavioural therapy) during 12 weeks in 2-hourly weekly sessions. ANALYSIS: the standardized mean response and the standardized effect size will be assessed at 3, 9, and 15 months after the beginning of the study using multiple linear regression models. Utility measurements will be used for the economic analysis. Phase 2: Qualitative socio constructivist study to evaluate the intervention according to the results obtained and the opinions and experiences of participants (patients and professionals). We will use theoretical sampling, with 2 discussion groups of participants in the multicomponent therapy and 2 discussion groups of professionals of different PCCs. A thematic content analysis will be carried out. ETHICS AND DISSEMINATION: This study protocol has been approved by the Clinical Research Ethics Committee of the Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (code P18/068). Articles will be published in international, peer-reviewed scientific journals. TRIAL REGISTRATION: Clinical-Trials.gov: NCT04049006.


Assuntos
Terapia Cognitivo-Comportamental/métodos , Terapia por Exercício/métodos , Fibromialgia/terapia , Educação de Pacientes como Assunto/métodos , Atenção Primária à Saúde/métodos , Qualidade de Vida , Adulto , Terapia Cognitivo-Comportamental/economia , Terapia Combinada , Análise Custo-Benefício , Terapia por Exercício/economia , Estudos de Viabilidade , Feminino , Fibromialgia/economia , Fibromialgia/psicologia , Implementação de Plano de Saúde , Humanos , Masculino , Avaliação de Processos e Resultados em Cuidados de Saúde , Aceitação pelo Paciente de Cuidados de Saúde , Cooperação do Paciente , Educação de Pacientes como Assunto/economia , Atenção Primária à Saúde/economia , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa
15.
J Foot Ankle Surg ; 58(5): 822-827, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31474396

RESUMO

Ankle fractures are common fractures of the lower extremities that have an incidence rate of 101 fractures per 100.000 person-years. It is not clear which rehabilitation intervention should be performed after an ankle fracture. The aims of this study are to compare the effectiveness of a supervised exercise program with that of a home exercise program and to determine and compare the costs of these programs. A supervised exercise program and a home exercise program were performed for 8 weeks. The supervised exercise group consisted of 35 patients (mean age 39.23 years), and the home exercise group consisted of 73 patients (mean age 41.78 years). The average follow-up was 27.86 ± 9.88 months. Demographic information, injury details, type and classification of fracture, pain severity, and ankle range of motion were recorded. The clinical outcomes were determined by using the Pain Disability Index, the American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score, and the Short-Form 36 Health Survey. Surgical and rehabilitation satisfaction was evaluated with the use of a numeric scale. American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Scores were statistically significantly higher in the home exercise group (p = .036), and rehabilitation satisfaction of the supervised exercise group was statistically significantly better (p = .047). The total rehabilitation crude cost of a patient in the supervised exercise group is 1113.63 Turkish lira (310.25 U.S. dollars) versus 182.31 Turkish lira (50.79 U.S. dollars) in the home exercise group. Considering that the crude cost of the home exercise program is very low and clinical outcomes are satisfactory, we recommend that patients with surgically treated isolated ankle fractures be followed up with a postoperative home exercise program.


Assuntos
Fraturas do Tornozelo/reabilitação , Terapia por Exercício/economia , Custos de Cuidados de Saúde , Serviços de Assistência Domiciliar/economia , Adulto , Idoso , Fraturas do Tornozelo/fisiopatologia , Fraturas do Tornozelo/cirurgia , Feminino , Fixação de Fratura , Humanos , Masculino , Pessoa de Meia-Idade , Qualidade de Vida , Amplitude de Movimento Articular , Recuperação de Função Fisiológica , Resultado do Tratamento , Adulto Jovem
16.
J Altern Complement Med ; 25(12): 1225-1237, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31556689

RESUMO

Objectives: Falls are common in Parkinson's disease (PD). Exercise interventions can prevent falls. This review aims to (1) explore the existing evidence regarding the cost-effectiveness of exercise-based fall prevention programs for people with PD and (2) discuss the implications of the review findings for future research and clinical practice. Design: Databases AMED Allied and Complementary Medicine, CINAHL, CRD, EBSCO, EMBASE, MEDLINE, PubMed, Scopus, and Web of Science were searched from their inception until June 2019. Randomized and nonrandomized trials that included an economic evaluation of fall prevention programs for people with PD were considered. Quality of the economic evaluation was assessed using the Consensus on Health Economic Criteria list (CHEC-list), and the methodological quality was assessed using the Physiotherapy Evidence Database (PEDro) and Cochrane risk of bias tool. Results: Nine hundred and sixty-five studies were screened to include three studies involving 556 participants. Quality of economic evaluation assessed using CHEC-list was high. The methodological quality was high for two studies and low for one study. Tested interventions included Tai Ji Quan, physiotherapist-led, supervised, weekly and monthly balance, and strengthening exercises. The duration of the interventions ranged from 10 weeks to 6 months, while the intervention frequency ranged from two sessions per week to one session per month. Treatment sessions lasted for 60 min in all three studies. One high economic and methodological quality study comparing Tai Ji Quan with resistance and stretching exercises reported least cost resource use among Tai Ji Quan group (USD 80,441) and greater incremental number of falls prevented. All three tested interventions had an 80% probability of being cost-effective with the corresponding country-specific threshold incremental cost-effectiveness ratio values. Conclusions: The findings provide some evidence for exercise-based intervention as a cost-effective treatment option for preventing falls in PD; however, due to the limited number of available studies, heterogeneity of the interventions, and diversity of assessment settings, a firm conclusion cannot be established. Additional studies evaluating the cost-effectiveness of fall prevention programs involving larger samples and using different treatment parameters in various settings are warranted.


Assuntos
Acidentes por Quedas/prevenção & controle , Terapia por Exercício , Doença de Parkinson/terapia , Idoso , Análise Custo-Benefício , Terapia por Exercício/economia , Terapia por Exercício/métodos , Terapia por Exercício/estatística & dados numéricos , Feminino , Humanos , Masculino , Tai Ji
17.
PLoS Med ; 16(9): e1002897, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31498799

RESUMO

BACKGROUND: Effective and cost-effective primary care treatments for low back pain (LBP) are required to reduce the burden of the world's most disabling condition. This study aimed to compare the clinical effectiveness and cost-effectiveness of the Fear Reduction Exercised Early (FREE) approach to LBP (intervention) with usual general practitioner (GP) care (control). METHODS AND FINDINGS: This pragmatic, cluster-randomised controlled trial with process evaluation and parallel economic evaluation was conducted in the Hutt Valley, New Zealand. Eight general practices were randomly assigned (stratified by practice size) with a 1:1 ratio to intervention (4 practices; 34 GPs) or control group (4 practices; 29 GPs). Adults presenting to these GPs with LBP as their primary complaint were recruited. GPs in the intervention practices were trained in the FREE approach, and patients presenting to these practices received care based on the FREE approach. The FREE approach restructures LBP consultations to prioritise early identification and management of barriers to recovery. GPs in control practices did not receive specific training for this study, and patients presenting to these practices received usual care. Between 23 September 2016 and 31 July 2017, 140 eligible patients presented to intervention practices (126 enrolled) and 110 eligible patients presented to control practices (100 enrolled). Patient mean age was 46.1 years (SD 14.4), and 46% were female. The duration of LBP was less than 6 weeks in 88% of patients. Primary outcome was change from baseline in patient participant Roland Morris Disability Questionnaire (RMDQ) score at 6 months. Secondary patient outcomes included pain, satisfaction, and psychosocial indices. GP outcomes included attitudes, knowledge, confidence, and GP LBP management behaviour. There was active and passive surveillance of potential harms. Patients and outcome assessors were blind to group assignment. Analysis followed intention-to-treat principles. A total of 122 (97%) patients from 32 GPs in the intervention group and 99 (99%) patients from 25 GPs in the control group were included in the primary outcome analysis. At 6 months, the groups did not significantly differ on the primary outcome (adjusted mean RMDQ score difference 0.57, 95% CI -0.64 to 1.78; p = 0.354) or secondary patient outcomes. The RMDQ difference met the predefined criterion to indicate noninferiority. One control group participant experienced an activity-related gluteal tear, with no other adverse events recorded. Intervention group GPs had improvements in attitudes, knowledge, and confidence compared with control group GPs. Intervention group GP LBP management behaviour became more guideline concordant than the control group. In cost-effectiveness, the intervention dominated control with lower costs and higher Quality-Adjusted Life Year (QALY) gains. Limitations of this study were that although adequately powered for primary outcome assessment, the study was not powered for evaluating some employment, healthcare use, and economic outcomes. It was also not possible for research nurses (responsible for patient recruitment) to be masked on group allocation for practices. CONCLUSIONS: Findings from this study suggest that the FREE approach improves GP concordance with LBP guideline recommendations but does not improve patient recovery outcomes compared with usual care. The FREE approach may reduce unnecessary healthcare use and produce economic benefits. Work participation or health resource use should be considered for primary outcome assessment in future trials of undifferentiated LBP. TRIAL REGISTRATION: ACTRN12616000888460.


Assuntos
Terapia por Exercício , Medo , Medicina Geral , Dor Lombar/terapia , Adulto , Análise Custo-Benefício , Avaliação da Deficiência , Terapia por Exercício/economia , Feminino , Comportamentos Relacionados com a Saúde , Custos de Cuidados de Saúde , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Dor Lombar/economia , Dor Lombar/fisiopatologia , Dor Lombar/psicologia , Masculino , Pessoa de Meia-Idade , Nova Zelândia , Medição da Dor , Anos de Vida Ajustados por Qualidade de Vida , Recuperação de Função Fisiológica , Fatores de Tempo , Resultado do Tratamento
18.
Medicina (Kaunas) ; 55(8)2019 Jul 30.
Artigo em Inglês | MEDLINE | ID: mdl-31366161

RESUMO

Background and Objectives: Gait training with body weight-support has been shown to improve the walking speed of individuals with movement disorders. The AccesSportAmerica Gait Trainer is a low-cost, pre-market gait rehabilitation device that alters the stride characteristics of participants walking on a standard treadmill. The purpose of this study was to examine the biomechanical outcomes that training on this device has for people with brain injuries that affect motor functioning. It was hypothesized that there would be an increase in walking speed post-intervention, and that there would be an increase in step length and joint range-of-motion. Materials and Methods: An intervention study was conducted with 11 people with ambulatory difficulty caused by post-stroke hemiparesis (n = 7), traumatic brain injury (n = 3), and cerebral palsy (n = 1). The average time using the AccesSportAmerica Gait Trainer was 34.5 (SD = 6.0) minutes per session for 36.9 (SD = 21.8) sessions. Gait speed, step length and time, and joint flexion were measured during the 10 Meter Walk Test. Results: From pre- to post-intervention, there was a mean increase in walking speed of 0.19 m/s (SD = 0.06, p = 0.016, d = 0.40) and a decrease in step time of both affected and unaffected legs (affected: p = 0.011, d = 0.37; unaffected: p = 0.004, d = 0.67). There was no significant change in stride length or joint angles. Conclusions: The AccesSportAmerica Gait Trainer has the potential to improve the walking speed of people with ambulatory difficulty.


Assuntos
Equipamentos e Provisões/normas , Terapia por Exercício/instrumentação , Amplitude de Movimento Articular/fisiologia , Velocidade de Caminhada/fisiologia , Adulto , Fenômenos Biomecânicos , Equipamentos e Provisões/estatística & dados numéricos , Terapia por Exercício/economia , Terapia por Exercício/normas , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Reabilitação do Acidente Vascular Cerebral/instrumentação , Reabilitação do Acidente Vascular Cerebral/normas , Reabilitação do Acidente Vascular Cerebral/estatística & dados numéricos
19.
Health Technol Assess ; 23(36): 1-150, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31339100

RESUMO

BACKGROUND: People with Parkinson's disease are twice as likely to experience a fall as a healthy older person, often leading to debilitating effects on confidence, activity levels and quality of life. OBJECTIVE: To estimate the effect of a physiotherapy programme for fall prevention among people with Parkinson's disease. DESIGN: A multicentre, pragmatic, investigator-masked, individually randomised controlled trial (RCT) with prespecified subgroup analyses. SETTING: Recruitment from NHS hospitals and clinics and community and social services in eight English regions with home-based interventions. PARTICIPANTS: A total of 474 people with Parkinson's disease (i.e. Hoehn and Yahr scale stages 1-4) were recruited: 238 were assigned to a physiotherapy programme and 236 were assigned to usual care. Random allocation was 50 : 50. INTERVENTIONS: All participants received routine care; the usual-care group received an information digital versatile disc (DVD) and a single advice session at trial completion. The intervention group had an individually tailored, progressive, home-based fall avoidance strategy training programme with balance and strengthening exercises: PDSAFE. MAIN OUTCOME MEASURES: The primary outcome was the risk of repeat falling, collected by self-report monthly diaries between 0 and 6 months after randomisation. Secondary outcomes included near-falls, falls efficacy, freezing of gait (FoG), health-related quality of life, and measurements taken using the Mini-Balance Evaluation Systems Test (Mini-BESTest), the Chair Stand Test (CST), the Geriatric Depression Scale, the Physical Activity Scale for the Elderly and the Parkinson's Disease Questionnaire. RESULTS: PDSAFE is the largest RCT of falls management among people with Parkinson's disease: 541 patients were screened for eligibility. The average age was 72 years, and 266 out of 474 (56%) participants were men. Of the 474 randomised participants, 238 were randomised to the intervention group and 236 were randomised to the control group. No difference in repeat falling within 6 months of randomisation was found [PDSAFE group to control group odds ratio (OR) 1.21, 95% confidence interval (CI) 0.74 to 1.98; p = 0.447]. An analysis of secondary outcomes demonstrated better balance (Mini-BESTest: mean difference 0.95, 95% CI 0.24 to 1.67; p = 0.009), functional strength (CST: p = 0.041) and falls efficacy (Falls Efficacy Scale - International: mean difference 1.6, 95% CI -3.0 to -0.19; p = 0.026) with near-falling significantly reduced with PDSAFE (OR 0.67, 95% CI 0.53 to 0.86; p = 0.001) at 6 months. Prespecified subgroup analysis (i.e. disease severity and FoG) revealed a PDSAFE differing effect; the intervention may be of benefit for people with moderate disease but may increase falling for those in the more severe category, especially those with FoG. LIMITATIONS: All participants were assessed at primary outcome; only 73% were assessed at 12 months owing to restricted funding. CONCLUSIONS: PDSAFE was not effective in reducing repeat falling across the range of people with Parkinson's disease in the trial. Secondary analysis demonstrated that other functional tasks and self-efficacy improved and demonstrated differential patterns of intervention impact in accordance with disease severity and FoG, which supports previous secondary research findings and merits further primary evaluation. FUTURE WORK: Further trials of falls prevention on targeted groups of people with Parkinson's disease are recommended. TRIAL REGISTRATION: Current Controlled Trials ISRCTN48152791. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 36. See the NIHR Journals Library website for further project information. Sarah E Lamb is funded by the NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) at Oxford Health NHS Foundation Trust, the NIHR Oxford Biomedical Research Centre at the Oxford University Hospitals NHS Foundation Trust and CLAHRC Oxford. Victoria A Goodwin is supported by the NIHR Collaborations for Leadership in Applied Health Research and Care in the South West Peninsula (PenCLAHRC). Lynn Rochester is supported by the NIHR Newcastle Biomedical Research Centre based at Newcastle upon Tyne Hospitals NHS Foundation Trust and Newcastle University. The research was also supported by the NIHR Newcastle Clinical Research Facility Infrastructure funding. Helen C Roberts is supported by CLAHRC Wessex and the NIHR Southampton Biomedical Research Centre.


Assuntos
Acidentes por Quedas/prevenção & controle , Terapia por Exercício , Transtornos Neurológicos da Marcha , Doença de Parkinson/complicações , Modalidades de Fisioterapia , Idoso , Terapia por Exercício/economia , Feminino , Humanos , Masculino
20.
Neurorehabil Neural Repair ; 33(8): 668-680, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-31296113

RESUMO

Background. As stroke survival improves, there is an increasing need for effective, low-cost programs to reduce deconditioning and improve mobility. Objective. To conduct a phase II trial examining whether the community-based Italian Adaptive Physical Activity exercise program for stroke survivors (APA-Stroke) is safe, effective, and feasible in the United States. Methods. In this single-blind, randomized controlled trial, 76 stroke survivors with mild to moderate hemiparesis >6 months were randomized to either APA-Stroke (N = 43) or Sittercise (N = 33). APA-Stroke is a progressive group exercise regimen tailored to hemiparesis that includes walking, strength, and balance training. Sittercise, a seated, nonprogressive aerobic upper body general exercise program, served as the control. Both interventions were 1 hour, 3 times weekly, in 5 community locations, supervised by exercise instructors. Results. A total of 76 participants aged 63.9 ± 1.2 years, mean months poststroke 61.8 ± 9.3, were included. There were no serious adverse events; completion rates were 58% for APA-Stroke, 70% for Sittercise. APA-Stroke participants improved significantly in walking speed. Sample size was inadequate to demonstrate significant between-group differences. Financial and logistical feasibility of the program has been demonstrated. Ongoing APA classes have been offered to >200 participants in county Senior Centers since study completion. Conclusion. APA-Stroke shows great promise as a low-cost, feasible intervention. It significantly increased walking speed. Safety and feasibility in the US context are demonstrated. A pivotal clinical trial is required to determine whether APA-Stroke should be considered standard of care.


Assuntos
Terapia por Exercício , Acidente Vascular Cerebral/terapia , Idoso , Serviços de Saúde Comunitária , Terapia por Exercício/economia , Terapia por Exercício/métodos , Estudos de Viabilidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Paresia/etiologia , Paresia/fisiopatologia , Paresia/terapia , Método Simples-Cego , Acidente Vascular Cerebral/complicações , Acidente Vascular Cerebral/fisiopatologia , Resultado do Tratamento , Estados Unidos
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