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OBJECTIVES: To develop a taxonomy of interventions and a programme theory explaining how interventions improve physical activity and function in people with long-term conditions managed in primary care. To co-design a prototype intervention informed by the programme theory. DESIGN: Realist synthesis combining evidence from a wide range of rich and relevant literature with stakeholder views. Resulting context, mechanism and outcome statements informed co-design and knowledge mobilisation workshops with stakeholders to develop a primary care service innovation. RESULTS: A taxonomy was produced, including 13 categories of physical activity interventions for people with long-term conditions. ABRIDGED REALIST PROGRAMME THEORY: Routinely addressing physical activity within consultations is dependent on a reinforcing practice culture, and targeted resources, with better coordination, will generate more opportunities to address low physical activity. The adaptation of physical activity promotion to individual needs and preferences of people with long-term conditions helps affect positive patient behaviour change. Training can improve knowledge, confidence and capability of practice staff to better promote physical activity. Engagement in any physical activity promotion programme will depend on the degree to which it makes sense to patients and professions, and is seen as trustworthy. CO-DESIGN: The programme theory informed the co-design of a prototype intervention to: improve physical literacy among practice staff; describe/develop the role of a physical activity advisor who can encourage the use of local opportunities to be more active; and provide materials to support behaviour change. CONCLUSIONS: Previous physical activity interventions in primary care have had limited effect. This may be because they have only partially addressed factors emerging in our programme theory. The co-designed prototype intervention aims to address all elements of this emergent theory, but needs further development and consideration alongside current schemes and contexts (including implications relevant to COVID-19), and testing in a future study. The integration of realist and co-design methods strengthened this study.
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COVID-19 , Exercício Físico , Humanos , Atenção Primária à Saúde , SARS-CoV-2RESUMO
INTRODUCTION: Proximal femoral (hip) fracture is common, serious and costly. Rehabilitation may improve functional recovery but evidence of effectiveness and cost-effectiveness are lacking. An enhanced rehabilitation intervention was previously developed and a feasibility study tested the methods used for this randomised controlled trial (RCT). The objectives are to compare the effectiveness and cost-effectiveness of the enhanced rehabilitation programme following surgical repair of proximal femoral fracture in older people compared with usual care. METHODS AND ANALYSIS: Protocol for phase III, parallel-group, two-armed, superiority, pragmatic RCT with 1:1 allocation ratio; allocation sequence by minimisation programme with a built-in random element; secure web-based allocation concealment. The two treatments will be usual care (control) and usual care plus an enhanced rehabilitation programme (intervention). The enhanced rehabilitation will consist of a patient-held information workbook, goal setting diary and up to six additional therapy sessions. Outcome assessment and statistical analysis will be performed blind; patient and carer participants will be unblinded. Outcomes will be measured at baseline, 17 and 52 weeks' follow-up. Primary outcome at 52 weeks will be the Nottingham Extended Activities of Daily Living scale. Secondary outcomes will measure anxiety and depression, health utility, cognitive status, hip pain intensity, falls self-efficacy, fear of falling, grip strength and physical function. Carer strain, anxiety and depression will be measured in carers. All safety events will be recorded, and serious adverse events will be assessed to determine whether they are related to the intervention and expected. Concurrent economic evaluation will be a cost-utility analysis from a health service and personal social care perspective. An embedded process evaluation will determine the mechanisms and processes that explain the implementation and impacts of the enhanced rehabilitation programme. ETHICS AND DISSEMINATION: National Health Service research ethics approval reference 18/NE/0300. Results will be disseminated by peer-reviewed publication. TRIAL REGISTRATION NUMBER: ISRCTN28376407; Pre-results registered on 23 November 2018.
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Fraturas do Quadril , Acidentes por Quedas , Atividades Cotidianas , Idoso , Idoso de 80 Anos ou mais , Análise Custo-Benefício , Fêmur , Fraturas do Quadril/cirurgia , Humanos , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
INTRODUCTION: People with long-term conditions typically have reduced physical functioning, are less physically active and therefore become less able to live independently and do the things they enjoy. However, assessment and promotion of physical function and physical activity is not part of routine management in primary care. This project aims to develop evidence-based recommendations about how primary care can best help people to become more physically active in order to maintain and improve their physical function, thus promoting independence. METHODS AND ANALYSIS: This study takes a realist synthesis approach, following RAMESES guidance, with embedded co-production and co-design. Stage 1 will develop initial programme theories about physical activity and physical function for people with long-term conditions, based on a review of the scientific and grey literature, and two multisector stakeholder workshops using LEGO® SERIOUS PLAY®. Stage 2 will involve focused literature searching, data extraction and synthesis to provide evidence to support or refute the initial programme theories. Searches for evidence will focus on physical activity interventions involving the assessment of physical function which are relevant to primary care. We will describe 'what works', 'for whom' and 'in what circumstances' and develop conjectured programme theories using context, mechanism and outcome configurations. Stage 3 will test and refine these theories through individual stakeholder interviews. The resulting theory-driven recommendations will feed into Stage 4 which will involve three sequential co-design stakeholder workshops in which practical ideas for service innovation in primary care will be developed. ETHICS AND DISSEMINATION: Healthcare and Medical Sciences Academic Ethics Committee (Reference 2018-16308) and NHS Wales Research Ethics Committee 5 approval (References 256 729 and 262726) have been obtained. A knowledge mobilisation event will address issues relevant to wider implementation of the intervention and study findings. Findings will be disseminated through peer-reviewed journal publications, conference presentations and formal and informal reports. PROSPERO REGISTRATION NUMBER: CRD42018103027.
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Doença Crônica , Exercício Físico , Promoção da Saúde , Atenção Primária à Saúde , Medicina Estatal , Atenção à Saúde , Humanos , Literatura de Revisão como AssuntoRESUMO
OBJECTIVE: Adverse changes in body composition, specifically decreased muscle mass (MM) and increased fat mass, characterize rheumatoid arthritis (RA). These changes, termed rheumatoid cachexia (RC), are important contributors to the disability and elevated co-morbidity risk of RA. Recently, we observed substantial muscle loss (~2 kg) in a patient with RA following a single intramuscular (IM) corticosteroid (CS) injection to treat a disease flare. The aim of the current study is to determine whether this apparent iatrogenic effect of IM CS is typical, i.e., does this routine, recommended treatment contribute to RC? METHODS: Body composition was assessed by dual-energy X-ray absorptiometry (DXA) in eight patients with established RA who received a 120 mg IM methylprednisolone injection to treat a disease flare. DXA scans estimated appendicular lean mass (ALM; a surrogate measure of MM), total lean mass (LM), and total and regional adiposity at baseline (injection day) and 4 weeks and 6-9 months post-injection. Statistical analysis was performed using one-way ANOVA. RESULTS: There was significant loss of ALM (-0.93 kg, p=0.001, 95% CI [-0.49, -1.36]) and a trend toward reduced LM (-1.10 kg, p=0.165, 95% CI [0.58, -2.79]) at 4 weeks relative to baseline. At 6-9 months despite control of inflammation and disease activity, these losses remained. CONCLUSION: Substantial muscle loss occurred in patients with RA following IM CS injection to treat a disease flare. Thus, this recommended treatment appears to exacerbate RC, thereby potentially increasing disability and co-morbidity risk. If this effect is confirmed by larger studies, the role of one-off high-dose CS in the treatment of RA should be reviewed.
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OBJECTIVES: RA is characterized by poor physical function, which compromises patients' quality of life and outcome. Clinical assessment of function is usually performed using self-reported questionnaires, such as the Multi-Dimensional HAQ (MDHAQ) and the Short Form-36 (physical component) (SF36-PC). However, such subjective measures may not accurately reflect real functional status. This study aimed to determine: (i) which clinically practicable objective test best represents overall physical function; and (ii) the extent to which self-reported subjective functional measures reflect objectively assessed function. METHODS: Objective [isometric knee extensor strength, handgrip strength, sit-to-stands in 30 s, 8-foot up and go (8'UG), 50-foot walk (50'W) and estimated aerobic capacity (VÌO2max)] and subjective (MDHAQ and SF36-PC) measures of function were correlated with one another to determine the best overall test of functional status in 82 well-controlled RA patients (DAS28 (s.d.) = 2.8 (1.0)). RESULTS: In rank order of size, averaged correlations (r) to the other outcome measures were as follows: 8'UG: 0.650; 50'W: 0.636; isometric knee extensor strength: 0.502; handgrip strength: 0.449; sit-to-stands in 30 s: 0.432; and estimated VÌO2max: 0.358. The MDHAQ was weakly (0.361) and the SF36-PC moderately correlated (0.415) with objective measures. CONCLUSION: Our results show that the most appropriate measure of objective physical function in RA patients is the 8'UG, followed by the 50'W. We found discordance between objectively and subjectively measured function. In clinical practice, an objective measure that is simple and quick to perform, such as the 8'UG, is advocated for assessing real functional status.
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OBJECTIVES: To develop an evidence and theory-based complex intervention for improving outcomes in elderly patients following hip fracture. DESIGN: Complex-intervention development (Medical Research Council (MRC) framework phase I) using realist literature review, surveys and focus groups of patients and rehabilitation teams. SETTING: North Wales. PARTICIPANTS: Surveys of therapy managers (n=13), community and hospital-based physiotherapists (n=129) and occupational therapists (n=68) throughout the UK. Focus groups with patients (n=13), their carers (n=4) and members of the multidisciplinary rehabilitation teams in North Wales (n=13). RESULTS: The realist review provided understanding of how rehabilitation interventions work in the real-world context and three programme theories were developed: improving patient engagement by tailoring the intervention to individual needs; reducing fear of falling and improving self-efficacy to exercise and perform activities of daily living; and coordination of rehabilitation delivery. The survey provided context about usual rehabilitation practice; focus groups provided data on the experience, acceptability and feasibility of rehabilitation interventions. An intervention to enhance usual rehabilitation was developed to target these theory areas comprising: a physical component consisting of six additional therapy sessions; and a psychological component consisting of a workbook to enhance self-efficacy and a patient-held goal-setting diary for self-monitoring. CONCLUSIONS: A realist approach may have advantages in the development of evidence-based interventions and can be used in conjunction with other established methods to contribute to the development of potentially more effective interventions. A rehabilitation intervention was developed which can be tested in a future randomised controlled trial (MRC framework phases II and III). TRIAL REGISTRATION NUMBER: ISRCTN22464643, Pre-results.
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Prestação Integrada de Cuidados de Saúde/organização & administração , Terapia por Exercício/métodos , Fraturas do Quadril/reabilitação , Terapia Ocupacional/métodos , Desenvolvimento de Programas , Acidentes por Quedas/prevenção & controle , Atividades Cotidianas , Idoso , Idoso de 80 Anos ou mais , Medicina Baseada em Evidências , Grupos Focais , Idoso Fragilizado/psicologia , Avaliação Geriátrica , Fraturas do Quadril/economia , Humanos , Avaliação de Resultados em Cuidados de Saúde , Autoeficácia , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Proximal femoral fracture is a major health problem in old age, with annual UK health and social care costs of £2.3B. Rehabilitation has the potential to maximise functional recovery and maintain independent living, but evidence of clinical effectiveness and cost-effectiveness is lacking. OBJECTIVES: To develop an enhanced community-based rehabilitation package following surgical treatment for proximal femoral fracture and to assess acceptability and feasibility for a future definitive randomised controlled trial (RCT) and economic evaluation. DESIGN: Phase I - realist review, survey and focus groups to develop the rehabilitation package. Phase II - parallel-group, randomised (using a dynamic adaptive algorithm) feasibility study with focus groups and an anonymised cohort study. SETTING: Recruitment was from orthopaedic wards of three acute hospitals in the Betsi Cadwaladr University Health Board, North Wales. The intervention was delivered in the community following hospital discharge. PARTICIPANTS: Older adults (aged ≥ 65 years) who had received surgical treatment for hip fracture, lived independently prior to fracture, had mental capacity (assessed by the clinical team) and received rehabilitation in the North Wales area. INTERVENTIONS: Participants received usual care (control) or usual care plus an enhanced rehabilitation package (intervention). Usual care was variable and consisted of multidisciplinary rehabilitation delivered by the acute hospital, community hospital and community services depending on need and availability. The intervention was designed to enhance rehabilitation by improving patients' self-efficacy and increasing the amount and quality of patients' practice of physical exercise and activities of daily living. It consisted of a patient-held information workbook, a goal-setting diary and six additional therapy sessions. MAIN OUTCOME MEASURES: The primary outcome measure was the Barthel Activities of Daily Living (BADL) index. The secondary outcome measures included the Nottingham Extended Activities of Daily Living (NEADL) scale, EuroQol-5 Dimensions, ICEpop CAPability measure for Older people, General Self-Efficacy Scale, Falls Efficacy Scale - International (FES-I), Self-Efficacy for Exercise scale, Hospital Anxiety and Depression Scale (HADS) and service use measures. Outcome measures were assessed at baseline and at 3-month follow-up by blinded researchers. RESULTS: Sixty-two participants were recruited (23% of those who were eligible), 61 were randomised (control, n = 32; intervention, n = 29) and 49 (79%) were followed up at 3 months. Compared with the cohort study, a younger, healthier subpopulation was recruited. There were minimal differences in most outcomes between the two groups, including the BADL index, with an adjusted mean difference of 0.5 (Cohen's d = 0.29). The intervention group showed a medium-sized improvement on the NEADL scale relative to the control group, with an adjusted mean difference between groups of 3.0 (Cohen's d = 0.63). There was a trend for greater improvement in FES-I and HADS in the intervention group, but with small effect sizes, with an adjusted mean difference of 4.2 (Cohen's d = 0.31) and 1.3 (Cohen's d = 0.20), respectively. The cost of delivering the intervention was £231 per patient. There was a possible small relative increase in quality-adjusted life-years in the intervention group. No serious adverse events relating to the intervention were reported. CONCLUSIONS: Trial methods were feasible in terms of eligibility, recruitment and retention, although recruitment was challenging. The NEADL scale was more responsive than the BADL index, suggesting that the intervention could enable participants to regain better levels of independence compared with usual care. This should be tested in a definitive Phase III RCT. There were two main limitations of the study: the feasibility study lacked power to test for differences between the groups and a ceiling effect was observed in the primary measure. TRIAL REGISTRATION: Current Controlled Trials ISRCTN22464643. 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. 21, No. 44. See the NIHR Journals Library for further project information.
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Análise Custo-Benefício/economia , Fraturas do Quadril/reabilitação , Avaliação da Tecnologia Biomédica , Atividades Cotidianas , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Estudos de Viabilidade , Feminino , Humanos , Masculino , Reino UnidoRESUMO
OBJECTIVE: To conduct a rigorous feasibility study for a future definitive parallel-group randomised controlled trial (RCT) and economic evaluation of an enhanced rehabilitation package for hip fracture. SETTING: Recruitment from 3 acute hospitals in North Wales. Intervention delivery in the community. PARTICIPANTS: Older adults (aged ≥65) who received surgical treatment for hip fracture, lived independently prior to fracture, had mental capacity (assessed by clinical team) and received rehabilitation in the North Wales area. INTERVENTION: Remote randomisation to usual care (control) or usual care+enhanced rehabilitation package (intervention), including six additional home-based physiotherapy sessions delivered by a physiotherapist or technical instructor, novel information workbook and goal-setting diary. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary: Barthel Activities of Daily Living (BADL). Secondary measures included Nottingham Extended Activities of Daily Living scale (NEADL), EQ-5D, ICECAP capability, a suite of self-efficacy, psychosocial and service-use measures and costs. Outcome measures were assessed at baseline and 3-month follow-up by blinded researchers. RESULTS: 62 participants were recruited, 61 randomised (control 32; intervention 29) and 49 (79%) completed 3-month follow-up. Minimal differences occurred between the 2 groups for most outcomes, including BADL (adjusted mean difference 0.5). The intervention group showed a medium-sized improvement in the NEADL relative to the control group, with an adjusted mean difference between groups of 3.0 (Cohen's d 0.63), and a trend for greater improvement in self-efficacy and mental health, but with small effect sizes. The mean cost of delivering the intervention was £231 per patient. There was a small relative improvement in quality-adjusted life year in the intervention group. No serious adverse events relating to the intervention were reported. CONCLUSIONS: The trial methods were feasible in terms of eligibility, recruitment and retention. The effectiveness and cost-effectiveness of the rehabilitation package should be tested in a phase III RCT. TRIAL REGISTRATION NUMBER: ISRCTN22464643; Results.
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Fraturas do Quadril/reabilitação , Modalidades de Fisioterapia , Atividades Cotidianas , Idoso , Idoso de 80 Anos ou mais , Análise Custo-Benefício , Estudos de Viabilidade , Feminino , Serviços de Assistência Domiciliar/economia , Humanos , Masculino , Modalidades de Fisioterapia/economia , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida , Autoeficácia , País de GalesRESUMO
OBJECTIVE: RA typically features rheumatoid cachexia [loss of muscle mass (MM) and excessive total fat mass (TFM), especially trunk FM], which contributes to physical disability. Since rheumatoid cachexia is driven by inflammation, it would be anticipated that the success of tight control of disease activity, such as treat-to-target (T2T), in attenuating inflammation would benefit body composition and physical function. This aim of this cross-sectional study was to assess the impact of T2T on body composition and objectively assessed function in RA patients. METHODS: A total of 82 RA patients exclusively treated by T2T, were compared with 85 matched sedentary healthy controls (HCs). Body composition was estimated by DXA, with appendicular lean mass the surrogate measure of total MM. Physical function was assessed by knee extensor strength, handgrip strength, 30 s sit-to-stands, 8' up and go, and 50' walk (tests which reflect the ability to perform activities of daily living). RESULTS: Although generally well treated (mean DAS28 = 2.8, with 49% in remission), RA patients had â¼10% proportionally less appendicular lean mass and were considerably fatter (by â¼27%), particularly in the trunk (â¼32%), than HCs. All measures of function were 24-34% poorer in the RA patients relative to HC. CONCLUSIONS: Despite marked improvements in disease control (most patients achieving or approaching remission), the relative loss of MM and increased adiposity in RA patients compared with matched HCs was similar to that observed pre-T2T. Additionally, performance of objective function tests was unchanged from that reported by our group for pre-T2T RA patients. Thus T2T, even in responsive RA patients, did not attenuate rheumatoid cachexia or improve objectively assessed function.
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Artrite Reumatoide/prevenção & controle , Composição Corporal/fisiologia , Atividades Cotidianas , Artrite Reumatoide/fisiopatologia , Caquexia/fisiopatologia , Caquexia/prevenção & controle , Estudos de Casos e Controles , Estudos Transversais , Pessoas com Deficiência , Exercício Físico/fisiologia , Feminino , Força da Mão/fisiologia , Nível de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Força Muscular/fisiologia , Músculo Esquelético/fisiopatologia , Resultado do Tratamento , Circunferência da Cintura/fisiologiaRESUMO
BACKGROUND: In-hospital progressive resistance training (PRT) has been shown to be an effective method of rehabilitation following hip surgery. The aim of this study was to assess whether a home-based PRT program would be beneficial in improving patients' muscle strength and physical function compared to standard rehabilitation. METHODS: Subjects (n = 49) either received home-based PRT rehabilitation (n = 25) or standard rehabilitation (n = 24) in a prospective single blinded randomized trial carried out over a two-year period. The primary outcome measure was the maximal voluntary contraction of the operated leg quadriceps (MVCOLQ) with secondary measures of outcome being the sit to stand score (ST), timed up and go (TUG), stair climb performance (SCP), the 6 min walk test (6MWT), and lean mass of the operated leg (LM). RESULTS: Twenty-six patients completed follow up at 1 year (n = 13 per group) for the final comparative analysis. All the outcome measures showed marked progressive improvements from the baseline measures at 9-12 months post op (Estimated effect (std error); p value)- MVCOLQ 26.50 (8.71) N p = 0.001; ST 1.37 (0.33) p = 0.0001; TUG -1.44 (0.45) s p =0.0001; SCP -3.41(0.80)s p = 0.0001; 6MWT 45.61 (6.10)m p = 0.0001; LM 20 (204)g p = 0.326) following surgery for both groups. Overall, there was no significant effect for participation in the exercise regime compared with standard care for all outcomes assessed. CONCLUSIONS: Overall, this study demonstrated that there is no significant difference between the two groups for participation in the home-based PRT exercise programme when compared to standard care for all outcomes. TRIAL REGISTRATION: ISRCTN 1309951. Registered February 2011.
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Artroplastia de Quadril/efeitos adversos , Serviços de Assistência Domiciliar , Osteoartrite do Quadril/reabilitação , Osteoartrite do Quadril/cirurgia , Treinamento Resistido/métodos , Idoso , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Força Muscular/fisiologia , Osteoartrite do Quadril/diagnóstico , Modalidades de Fisioterapia , Projetos Piloto , Estudos Prospectivos , Método Simples-CegoAssuntos
Artrite Reumatoide/complicações , Caquexia/etiologia , Artrite Reumatoide/fisiopatologia , Artrite Reumatoide/terapia , Composição Corporal/fisiologia , Caquexia/diagnóstico , Caquexia/fisiopatologia , Caquexia/terapia , Exercício Físico/fisiologia , Humanos , Recuperação de Função Fisiológica/fisiologiaRESUMO
OBJECTIVE: Rheumatoid cachexia (muscle wasting) in rheumatoid arthritis (RA) patients contributes to substantial reductions in strength and impaired physical function. The objective of this randomized controlled trial was to investigate the effectiveness of oral creatine (Cr) supplementation in increasing lean mass and improving strength and physical function in RA patients. METHODS: In a double-blind design, 40 RA patients were randomized to either 12 weeks' supplementation of Cr or placebo. Body composition (dual x-ray absorptiometry and bioelectrical impedance spectroscopy [BIS]), strength, and objectively assessed physical function were measured at baseline, day 6, week 12, and week 24. Data analysis was performed by analysis of covariance. RESULTS: Cr supplementation increased appendicular lean mass (ALM; a surrogate measure of muscle mass) by mean ± SE 0.52 ± 0.13 kg (P = 0.004 versus placebo), and total LM by 0.60 ± 0.37 kg (P = 0.158). The change in LM concurred with the gain in intracellular water (0.64 ± 0.22 liters; P = 0.035) measured by BIS. Despite increasing ALM, Cr supplementation, relative to placebo, failed to improve isometric knee extensor strength (P = 0.408), handgrip strength (P = 0.833), or objectively assessed physical function (P = 0.335-0.764). CONCLUSION: In patients with RA, Cr supplementation increased muscle mass, but not strength or objective physical function. No treatment-related adverse effects were reported, suggesting that Cr supplementation may offer a safe and acceptable adjunct treatment for attenuating muscle loss; this treatment may be beneficial for patients experiencing severe rheumatoid cachexia.
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Artrite Reumatoide/tratamento farmacológico , Creatina/uso terapêutico , Músculo Esquelético/efeitos dos fármacos , Absorciometria de Fóton , Adulto , Idoso , Suplementos Nutricionais , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Força Muscular/efeitos dos fármacosRESUMO
BACKGROUND: Proximal femoral fracture is a common, major health problem in old age resulting in loss of functional independence and a high-cost burden on society, with estimated health and social care costs of £2.3 billion per year in the UK. Rehabilitation has the potential to maximise functional recovery and maintain independent living, but evidence of effectiveness is lacking. Usual rehabilitation care is delivered by a multi-disciplinary team in the hospital and in the community. An 'enhanced rehabilitation' intervention has been developed consisting of a workbook, goal-setting diary and extra therapy sessions, designed to improve self-efficacy and increase the amount and quality of the practice of physical exercise and activities of daily living. METHODS/DESIGN: This paper describes the design of a phase II study comprising an anonymous cohort of all proximal femoral fracture patients admitted to the three acute hospitals in Betsi Cadwaladr University Health Board over a 6-month period with a randomised feasibility study comparing the enhanced rehabilitation intervention with usual care. These will assess the feasibility of a future definitive randomised controlled trial and concurrent economic evaluation in terms of recruitment, retention, outcome measure completion, compliance with the intervention and fidelity of delivery, health service use data, willingness to be randomised and effect size for a future sample size calculation. Focus groups will provide qualitative data to contribute to the assessment of the acceptability of the intervention amongst patients, carers and rehabilitation professionals and the feasibility of delivering the planned intervention. The primary outcome measure is function assessed by the Barthel Index. Secondary outcomes measure the ability to perform activities of daily living, anxiety and depression, potential mediators of outcomes such as hip pain, self-efficacy and fear of falling, health utility, health service use, objectively assessed physical function and adverse events. Participants' preference for rehabilitation services will be assessed in a discrete choice experiment. DISCUSSION: Phase II studies are an opportunity to not only assess the feasibility of trial methods but also to compare different methods of outcome measurement and novel methods of obtaining health service use data from routinely collected patient information. TRIAL REGISTRATION: Current Controlled Trials ISRCTN22464643, UKCRN16677.
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OBJECTIVE: Rheumatoid arthritis (RA) and ankylosing spondylitis (AS) lead to inflammation in tendons and peritendinous tissues, but effects on biomechanical tendon function are unknown. This study investigated patellar tendon (PT) properties in stable, established RA and AS patients. METHODS: We compared 18 RA patients (13 women, 59.0 ± 2.8 years, mean ± SEM) with 18 age- and sex-matched healthy controls (58.2 ± 3.2 years), and 12 AS patients (4 women, 52.9 ± 3.4 years) with 12 matched controls (54.5 ± 4.7 years). Assessments with electromyography, isokinetic dynamometry, and ultrasound included quadriceps muscle force and cross-sectional area (CSA), PT stiffness, and PT CSA. Additionally, measures of physical function and disease activity were performed. RESULTS: PT stiffness and physical function were lower in RA and AS patients compared to healthy controls, without a significant difference in force production. PT CSA was significantly larger leading to reduction in Young's modulus (YM) in AS, but not in RA. CONCLUSION: The adverse changes in PT properties in RA and AS may contribute to their impaired physical function. AS, but not RA, leads to PT thickening without increasing PT stiffness, suggesting that PT thickening in AS is a disorganised repair process. Longitudinal studies need to investigate the time course of these changes and their response to exercise training.
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Artrite Reumatoide/fisiopatologia , Marcha , Perna (Membro)/fisiopatologia , Atividade Motora , Músculo Esquelético/fisiopatologia , Ligamento Patelar/fisiopatologia , Espondilite Anquilosante/fisiopatologia , Estudos Transversais , Módulo de Elasticidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Tamanho do Órgão , Valores de Referência , Estresse MecânicoRESUMO
Unaccustomed strenuous physical exertion in hot environments can result in heat stroke and acute kidney injury (AKI). Both exercise-induced muscle damage and AKI are associated with the release of interleukin-6, but whether muscle damage causes AKI in the heat is unknown. We hypothesized that muscle-damaging exercise, before exercise in the heat, would increase kidney stress. Ten healthy euhydrated men underwent a randomized, crossover trial involving both a 60-min downhill muscle-damaging run (exercise-induced muscle damage; EIMD), and an exercise intensity-matched non-muscle-damaging flat run (CON), in random order separated by 2 wk. Both treatments were followed by heat stress elicited by a 40-min run at 33°C. Urine and blood were sampled at baseline, after treatment, and after subjects ran in the heat. By design, EIMD induced higher plasma creatine kinase and interleukin-6 than CON. EIMD elevated kidney injury biomarkers (e.g., urinary neutrophil gelatinase-associated lipocalin (NGAL) after a run in the heat: EIMD-CON, mean difference [95% CI]: 12 [5, 19] ng/ml) and reduced kidney function (e.g., plasma creatinine after a run in the heat: EIMD-CON, mean difference [95% CI]: 0.2 [0.1, 0.3] mg/dl), where CI is the confidence interval. Plasma interleukin-6 was positively correlated with plasma NGAL (r = 0.9, P = 0.001). Moreover, following EIMD, 5 of 10 participants met AKIN criteria for AKI. Thus for the first time we demonstrate that muscle-damaging exercise before running in the heat results in a greater inflammatory state and kidney stress compared with non-muscle-damaging exercise. Muscle damage should therefore be considered a risk factor for AKI when performing exercise in hot environments.
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Injúria Renal Aguda/fisiopatologia , Biomarcadores/sangue , Exercício Físico , Transtornos de Estresse por Calor/etiologia , Temperatura Alta/efeitos adversos , Rim/fisiopatologia , Doenças Musculares/etiologia , Proteínas de Fase Aguda/urina , Adulto , Creatinina/sangue , Estudos Cross-Over , Humanos , Interleucina-6/urina , Lipocalina-2 , Lipocalinas/urina , Masculino , Doenças Musculares/patologia , Esforço Físico , Proteínas Proto-Oncogênicas/urina , Corrida/lesões , Regulação para CimaRESUMO
BACKGROUND: There is evidence of prolonged poor function in patients following total hip replacement (THR). Studies of progressive resistance training (PRT) interventions to improve function are often compared to 'standard' practice which is not well defined. This study aimed to investigate 'standard' rehabilitation care in the UK after total hip replacement (THR) as well as determine whether PRT was part of 'standard' care. METHODS: After ethical approval, questionnaire item development about rehabilitation practice was guided by a focus group interview (after informed consent) with physiotherapists (n = 4; >5 years post-qualification) who regularly treated THR patients. An online questionnaire investigating the exercises prescribed and rehabilitation practice following THR was developed and sent to physiotherapists working in hospitals in the UK. The survey was performed from January to May 2011. The survey results were analysed (frequency (%) of responses) focusing on the exercises the physiotherapists considered important, as well as their use of PRT in prescribed regimes. RESULTS: 106 responses were obtained from physiotherapists in the UK. The survey respondents considered that the most important muscles to target in all phases of rehabilitation were the hip abductors (62.2%), followed by the quadriceps (16.9%), and other muscles (21%). Exercise type prescribed revealed no consensus, with weight bearing (42%), functional (45%) and Bed-based/Bridging/Postural exercises (13%) favoured. 83.7% were able to define the basis of progressive resistance training (PRT), but only 33% prescribed it. CONCLUSIONS: Standard physiotherapy rehabilitation in the UK after THR is variable, and appears to rarely include PRT. This may be a factor in prolonged poor function in some patients after this common operation.
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Artroplastia de Quadril , Articulação do Quadril/cirurgia , Fisioterapeutas/normas , Treinamento Resistido/normas , Padrão de Cuidado , Artroplastia de Quadril/efeitos adversos , Atitude do Pessoal de Saúde , Fenômenos Biomecânicos , Continuidade da Assistência ao Paciente/normas , Grupos Focais , Pesquisas sobre Atenção à Saúde , Conhecimentos, Atitudes e Prática em Saúde , Articulação do Quadril/fisiopatologia , Humanos , Internet , Fisioterapeutas/psicologia , Cuidados Pós-Operatórios/normas , Recuperação de Função Fisiológica , Medicina Estatal/normas , Inquéritos e Questionários , Resultado do Tratamento , Reino UnidoRESUMO
Purpose. Exercise tests represent an important clinical tool to evaluate cardio-respiratory fitness and to predict future adverse cardiovascular events. However, use of such tests in patients with rheumatoid arthritis (RA) is relatively uncommon despite well-established evidence that low exercise capacity and high CVD mortality are features of this disease. Therefore, this study examined the validity and reliability of a sub-maximal step test for use in RA patients. Methods. Thirty patients (24 females) (mean ± SD age 53 ± 10 years) performed a sub-maximal step test on two occasions to estimate the criterion measure of cardio-respiratory fitness ([Formula: see text]). A further maximal cycling test provided a direct fitness measurement ([Formula: see text]). Pearson correlation coefficient, intraclass correlation coefficient (ICC), Bland and Altman plots, and 95% limits of agreement (LOA) were used to determine the validity and reliability of the sub-maximal test. Results. Estimated [Formula: see text] correlated well with directly measured [Formula: see text] (r = 0.79, LoA ±5.7 mL·kg(-1) ·min(-1)). Test-retest reproducibility for estimated [Formula: see text] was excellent (ICC = 0.97, LoA ±2.2 mL·kg(-1) ·min(-1)). Conclusion. The sub-maximal step test studied here represents a valid and reproducible method to estimate cardio-respiratory fitness in RA patients. This test may be useful for the assessment and management of CVD risk in a clinical setting.
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AIM: We sought to determine if an acute kidney injury biomarker, neutrophil gelatinaseassociated lipocalin (NGAL), would be up-regulated by high-intensity proteinuria-inducing exercise. METHODS: A prospective cohort design was utilised. 100 healthy, active adults (mean age 24 ± 4 (SD) years) were screened for post-exercise proteinuria (PeP); 10 PeP positive and 10 PeP negative participants then completed a high-intensity exercise protocol involving an 800 meter sprint. Plasma and urinary NGAL, urinary creatinine, urinary albumin and urine volume were obtained at the following time points: pre-run, immediately post-, 25 minutes, one hour and two hours post-run. RESULTS: Following high-intensity exercise, 64% of participants had urinary NGAL concentrations above the normal range, particularly at 25 minutes post (P = 0.002). However, there was no difference in NGAL response between PeP positive and negative groups and plasma NGAL was decreased, not elevated, following exercise (P = 0.002). In some individuals normalizing urinary NGAL for urinary creatinine attenuated elevations. Urinary NGAL was also negatively correlated with urine volume (r = -0.701, P = 0.005). CONCLUSION: Proteinuria susceptibility did not influence an acute injury biomarker response to exercise. Nevertheless, urinary NGAL was elevated by exercise, possibly due to increased production by the proximal tubule, increased plasma clearance (given the decrease in plasma NGAL) and/or a concentrating effect of exercise-induced oliguria. Until correct normalisation of urinary biomarkers is determined, NGAL should be interpreted cautiously in exercise and acute kidney injury-induced oliguria. The inter-individual NGAL response to exercise also warrants further investigation.
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Injúria Renal Aguda/metabolismo , Proteínas de Fase Aguda/metabolismo , Lipocalinas/metabolismo , Atividade Motora/fisiologia , Proteinúria/etiologia , Proteinúria/metabolismo , Proteínas Proto-Oncogênicas/metabolismo , Injúria Renal Aguda/fisiopatologia , Adulto , Albuminúria/epidemiologia , Albuminúria/urina , Biomarcadores/metabolismo , Estudos de Coortes , Creatinina/metabolismo , Feminino , Humanos , Incidência , Lipocalina-2 , Masculino , Oligúria/epidemiologia , Oligúria/metabolismo , Estudos Prospectivos , Regulação para Cima/fisiologiaRESUMO
This study aimed to systematically review the literature with regards to studies of rehabilitation programmes that have tried to improve function after total hip replacement (THR) surgery. 15 randomised controlled trials were identified of which 11 were centre-based, 2 were home based and 2 were trials comparing home and centre based interventions. The use of a progressive resistance training (PRT) programme led to significant improvement in muscle strength and function if the intervention was carried out early (< 1 month following surgery) in a centre (6/11 centre-based studies used PRT), or late (> 1 month following surgery) in a home based setting (2/2 home based studies used PRT). In direct comparison, there was no difference in functional measures between home and centre based programmes (2 studies), with PRT not included in the regimes prescribed. A limitation of the majority of these intervention studies was the short period of follow up. Centre based program delivery is expensive as high costs are associated with supervision, facility provision, and transport of patients. Early interventions are important to counteract the deficit in muscle strength in the affected limb, as well as persistent atrophy that exists around the affected hip at 2 years post-operatively. Studies of early home-based regimes featuring PRT with long term follow up are needed to address the problems currently associated with rehabilitation following THR.
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OBJECTIVE: Rheumatoid arthritis (RA) patients were reassessed for body composition and physical function mean ± SD 39 ± 6 months after commencing a randomized controlled trial involving 24 weeks of either high-intensity progressive resistance training (PRT) or low-intensity range of movement exercise (control) to determine whether the benefits of PRT (i.e., reduced fat mass [FM], increased lean mass [LM], and improved function) were retained. METHODS: Nine PRT and 9 control subjects were reassessed for body composition (dual x-ray absorptiometry) and function (knee extensor strength, chair test, arm curl test, 50-foot walk) approximately 3 years after resuming normal activity following the exercise intervention. RESULTS: At followup, PRT subjects remained significantly leaner than control subjects (P = 0.03), who conversely had accumulated considerable FM during the study period (approximately -1.0 kg versus +2.4 kg, PRT versus controls). PRT subjects also retained most of the improvement in walking speed gained from training (P = 0.03 versus controls at followup). In contrast, the PRT-induced gains in LM and strength-related function were completely lost. Data from the controls suggest that established and stable RA patients have similar rates of LM loss but elevated rates of FM accretion relative to age-matched sedentary non-RA controls. CONCLUSION: We found that long-term resumption of normal activity resulted in loss of PRT-induced improvements in LM and strength-related function, but substantial retention of the benefits in FM reduction and walking ability. The relatively long-term benefit of reduced adiposity, in particular, is likely to be clinically significant, as obesity is very prevalent among RA patients and is associated with their disability and exacerbated cardiovascular disease risk.