Clinical trial registration has become more prevalent in physical therapy but it is still inadequate: A meta-research study.

BACKGROUND: A study using data from 2009 showed low prevalence and inadequate trial registration in physiotherapy. In 2013, a joint editorial recommended prospective registration in physiotherapy journals. Ten years later it is unclear whether the joint editorial achieved its intended benefit. OBJECTIVES: To investigate the proportion of randomized trials adequately registered and the extent of selective reporting of outcomes in trials of physiotherapy interventions published in 2019 and to compare these data with equivalent published data from 2009. DESIGN: Meta-research study. METHOD: A random sample of 200 trials published in 2019 was used. Evidence of registration was sought on trial registers and by contacting authors. Data from the article was compared with data from the trial registration. Data from this sample of trial published in 2019 were compared with equivalent published data from 2009. RESULTS: In 2019, the proportion of trials that were registered was 63% versus 34% in 2009 (absolute difference 29%). In 2019, 18% of the trials were prospectively registered compared to 6% in 2009 (absolute difference 12%). Unambiguous primary outcomes (i.e., method and timepoints of measurement clearly defined in the trial registry entry) were registered for 30% in 2019. Registration was adequate (i.e., prospective with unambiguous primary outcomes) for 8%, compared with 3% in 2009 (absolute difference 5%). Selective outcome reporting occurred in 73% of the trials in which it was assessable; in 2009 this proportion was 47% (absolute difference 26%). CONCLUSIONS: Registration of randomized trials in physiotherapy increased in the past decade, but it is still inadequate. More effort is still required to implement and enforce adequate registration.

Association Between Domain-Specific Physical Activity and Chronic Low Back Pain in Community-Dwelling Older Adults: A Cross-Sectional Study.

To investigate the association between physical activity (PA) domains and chronic low back pain (LBP) in older adults. A cross-sectional study where sociodemographic, behavioral, and health variables; PA; and presence of chronic LBP were collected. Higher scores of PA defined the "more active" participants. Binary logistic regression was used to test the association between PA domains and chronic LBP. A total of 516 participants were included. The mean age was 71.8 (95% confidence interval, CI, [71.1, 72.5]) years, and 29%, 27%, 25%, and 31% were identified as "more active" in the household, sports, leisure-time, and total PA domains, respectively. "More active" participants in sports (odds ratio = 0.62, 95% CI [0.40, 0.97]), leisure-time (odds ratio = 0.54, 95% CI [0.35, 0.85]) and total (odds ratio = 0.60, 95% CI [0.39, 0.92]) PA domains were less likely to report chronic LBP. High levels of sports, leisure-time, and total PA were inversely associated with chronic LBP.

Perceptions and preferences of patients with cardiac conditions to the inclusion of virtual reality-based therapy with conventional cardiovascular rehabilitation: A qualitative study.

BACKGROUND: Virtual reality-based therapy (VRBT) has been recently used in rehabilitation programs, as it can improve patient's adherence to treatment. However, patients' acceptance of VRBT has been scarcely investigated. OBJECTIVE: To qualitatively analyze the perceptions and preferences of patients about the inclusion of VRBT to a conventional cardiovascular rehabilitation program (CRP). METHODS: Fifteen patients from a randomized clinical trial participated in focus groups for qualitative assessment. RESULTS: Patients demonstrated good acceptance and satisfaction of VRBT. Physical and psychosocial benefits were highlighted, and patients reported the perception of higher exercise intensity in VRBT then when doing conventional training. In addition, the frequency of VRBT (once a week), associated with conventional treatment was reported as satisfactory. Cognitive aspects that influenced participation to the new approach were also raised by study participants. CONCLUSION: Patients with cardiac conditions demonstrated satisfaction with the inclusion of VRBT in a conventional CRP, demonstrating that VRBT has the potential to be a new approach for this patient population, allowing training diversification. Benefits perceived by patients include physical, mental, and social aspects. TRIAL REGISTERED: NCT04336306 (https://clinicaltrials.gov/ct2/show/NCT04336306).

Critical evaluation of physical activity questionnaires translated to Brazilian-Portuguese: a systematic review on cross-cultural adaptation and measurements properties.

BACKGROUND: The number of questionnaires that measures physical activity levels has increased considerably. For Brazilian population it becomes a challenge, due to the need of a rigorous translation, adaptation and testing of measurement properties. OBJECTIVE: Evaluate the methodological quality and criteria of physical activity questionnaires translated to Brazilian-Portuguese. METHODS: Methodological quality and quality criteria was assessed using the COnsensus-based Standards for the selection of health Measurement INstruments checklist. RESULTS: Sixty-nine studies were included, the most frequent questionnaires investigated were the International Physical Activity Questionnaire (n=16) and the Baecke Physical Activity Questionnaire (n=12). Translation (n=13), reliability (n=37) and construct validity (n=44) were the measurement properties commonly investigated. For reliability, most studies were rated as 'adequate' for methodological quality. The Intraclass Correlation Coefficient of the questionnaires ranged from 0.20 to 1.0. For construct validity, 31 analyses showed 'inadequate' methodological quality, due to poor description of the comparator instrument. High level of evidence on reliability were found for Baecke Physical Activity Questionnaire, Self-administered Physical Activity Checklist and Physical Activity Questionnaire of the Surveillance System of Risk Factors and Protection for Chronic Diseases; on construct validity for Self-administered Physical Activity Checklist, Physical activity Questionnaire for Adolescents, Physical activity Questionnaire for Older Children and Saúde naBoa Questionnaire. CONCLUSION: Most questionnaires showed poor methodological quality and measurement properties. The Baecke Physical Activity Questionnaire and Self-administred Physical Activity Checklist showed better scorings for methodological quality and quality criteria. Further high methodological quality studies are still warranted.

Effect of interventions using physical activity trackers on physical activity in people aged 60 years and over: a systematic review and meta-analysis.

BACKGROUND: Older people are at high risk of physical inactivity. Activity trackers can facilitate physical activity. We aimed to investigate the effect of interventions using activity trackers on physical activity, mobility, quality of life and mental health among people aged 60+ years. METHODS: For this systematic review, we searched eight databases, including MEDLINE, Embase and CENTRAL from inception to April 2018. Randomised controlled trials of interventions that used activity trackers to promote physical activity among people aged 60+ years were included in the analyses. The study protocol was registered with PROSPERO, number CRD42017065250. RESULTS: We identified 23 eligible trials. Interventions using activity trackers had a moderate effect on physical activity (23 studies; standardised mean difference (SMD)=0.55; 95% CI 0.40 to 0.70; I2=86%) and increased steps/day by 1558 (95% CI 1099 to 2018 steps/day; I2=92%) compared with usual care, no intervention and wait-list control. Longer duration activity tracker-based interventions were more effective than short duration interventions (18 studies, SMD=0.70; 95% CI 0.47 to 0.93 vs 5 studies, SMD=0.14; 95% CI -0.26 to 0.54, p for comparison=0.02). Interventions that used activity trackers improved mobility (three studies; SMD=0.61; 95% CI 0.31 to 0.90; I2=10%), but not quality of life (nine studies; SMD=0.09; 95% CI -0.07 to 0.25; I2=45%). Only one trial included mental health outcomes and it reported similar effects of the activity tracker intervention compared with control. CONCLUSIONS: Interventions using activity trackers improve physical activity levels and mobility among older people compared with control. However, the impact of activity tracker interventions on quality of life, and mental health is unknown.

The perceptions of physical therapists about facilitators and challenges in the use of different tools for resistance training in COPD patients: a mixed-method study / Percepção de fisioterapeutas sobre facilitadores e barreiras no uso de diferentes ferramentas para treinamento resistido em pacientes com DPOC: estudo de método mistos / Percepción de fisioterapeutas sobre facilitadores y barreras en el uso de diferentes herramientas de entrenamiento de resistencia en pacientes con EPOC: estudio de método mixto

ABSTRACT This study sought to quantify and qualitatively analyze the perception of physical therapists about facilitators and the challenges in the use of different types of tools for resistance training in chronic obstructive pulmonary disease (COPD) patients. This was a mixed-model study with qualitative analysis developed in a rehabilitation center. Six physical therapists who performed a randomized clinical trial were interviewed. The protocol consisted of the evaluation of three types of resistance training: elastic tubes, elastic bands, and training with conventional weight machines. After completion of the randomized trial, therapists were invited to participate in a focus group to collect qualitative data. Physical therapists also answered a quantitative questionnaire containing closed questions. The main outcome measures were the opinion of physical therapists about the advantages and disadvantages in clinical practice of each of the analyzed tools. The focus group analysis resulted in eight themes: Insecurities regarding load and handling tools, implementation of home-based treatment, improvements of tools, advantages and disadvantages of tools, incidence of injuries with elastic tools, patient's preferences, and particularities of the tools. Physical therapists pointed out different challenges and facilitators for resistance training. Characteristics of the tools such as costs, portability, handling and practicality were cited as factors that influence clinical practice. In the quantitative analysis, no differences were observed when comparing the scores of each instrument. The three tools analyzed are applicable and feasible in the clinical practice of physical therapists; moreover, they present different characteristics and particularities that should be considered, such as cost, clinical applicability, portability and perception of the patient and therapists.

RESUMO O objetivo do estudo foi quantificar e analisar qualitativamente a percepção de fisioterapeutas sobre facilitadores e barreiras no uso de diferentes ferramentas para treinamento resistido em pacientes com doença pulmonar obstrutiva crônica (DPOC). O método utilizado foi desenvolvido em um centro de reabilitação. Seis fisioterapeutas que participaram como terapeutas de um ensaio clínico randomizado foram entrevistados. O protocolo consistiu na avaliação de três ferramentas para treinamento resistido: tubos elásticos, bandas elásticas e treinamento convencional com equipamentos de musculação. Depois da finalização do ensaio clínico randomizado, os fisioterapeutas foram convidados a participar de um grupo focal para análise qualitativa e responder questionário fechado para análise quantitativa. Os profissionais opinaram sobre vantagens e desvantagens de cada uma das três ferramentas na prática clínica. A análise do grupo focal resultou em oito temas: insegurança em relação à carga e manuseio das ferramentas; implementação de tratamento domiciliar; melhorias para ferramentas; vantagens e desvantagens das ferramentas; incidência de lesões com ferramentas elásticas; preferência dos pacientes; e particularidades de cada ferramenta. Fisioterapeutas apontaram diferentes barreiras e facilitadores para o treinamento resistido. Características das ferramentas - como custo, portabilidade, manuseio, praticidade e percepção do paciente e fisioterapeuta - foram citadas como fatores que influenciam a prática clínica. Na análise quantitativa, nenhuma diferença foi observada quando comparados os escores para cada instrumento. As três ferramentas são aplicáveis na prática clínica do fisioterapeuta. Adicionalmente, as características e particularidades de cada uma delas devem ser consideradas.

RESUMEN El objetivo del estudio fue cuantificar y analizar cualitativamente la percepción de fisioterapeutas sobre facilitadores y barreras en el uso de diferentes herramientas de entrenamiento de resistencia en pacientes con enfermedad pulmonar obstructiva crónica (EPOC). El método utilizado fue desarrollado en un centro de rehabilitación. Seis profesionales que participaron como terapeutas en un ensayo clínico aleatorizado fueron entrevistados. El protocolo consistió en la evaluación de tres herramientas de entrenamiento de resistencia: tubos elásticos, bandas elásticas y entrenamiento convencional con equipo de entrenamiento con pesas. Después del ensayo clínico aleatorizado, se invitó a los fisioterapeutas a participar en un grupo focal para análisis cualitativo y a responder un cuestionario cerrado para análisis cuantitativo. Los profesionales opinaron sobre las ventajas y desventajas de cada una de las tres herramientas en la práctica clínica. El análisis del grupo resultó en ocho temas: falta de fiabilidad en lo referente a la carga y al manejo de las herramientas; puesta en práctica del tratamiento domiciliario; mejoras en las herramientas; ventajas y desventajas de las herramientas; incidencia de lesiones con las herramientas elásticas; preferencia de los pacientes; particularidades de cada herramienta. Los fisioterapeutas señalaron diferentes barreras y facilitadores para el entrenamiento de resistencia. Características de la herramienta - como costo, portabilidad, manejo, practicidad y percepción del paciente y del fisioterapeuta - fueron mencionadas como factores que influyen en la práctica clínica. En el análisis cuantitativo no se observaron diferencias de puntaje entre los instrumentos. Las tres herramientas son aplicables en la práctica clínica del fisioterapeuta. Además, se deben considerar las características y particularidades de cada una de ellas.

Psychometric Properties of the Photograph Series of Daily Activities-Short Electronic Version (PHODA-SeV) in Patients With Chronic Low Back Pain.

Background The Photograph Series of Daily Activities-short electronic version (PHODA-SeV) assesses perceived harmfulness of daily activities in patients with low back pain (LBP). Although there is some evidence that the PHODA-SeV is a reliable and valid tool, its psychometric properties have not been fully investigated. Objectives To investigate the test-retest reliability, measurement error, interpretability, construct validity, and internal and external responsiveness of the PHODA-SeV in patients with chronic LBP. Methods Ninety-one patients were included in the analysis for this prospective cohort study. For reliability purposes, the PHODA-SeV was administered twice, with a 1-week interval before beginning treatment. Pain, disability, and measures of pain-related fear (ie, PHODA-SeV, Fear-Avoidance Beliefs Questionnaire [FABQ], and Tampa Scale of Kinesiophobia [TSK]) were collected before and after the 8-week treatment period. Results The PHODA-SeV showed excellent reliability (intraclass correlation coefficient model 2,1 = 0.91), without evidence of ceiling and floor effects. The construct validity analysis demonstrated fair correlations (r = 0.25-0.50) of the PHODA-SeV with the FABQ, but no correlation with the TSK (r<0.25). For internal responsiveness, the PHODA-SeV showed an effect size of 0.87 and a standardized response mean of 0.92, interpreted as a large effect (greater than 0.80). For external responsiveness, the correlations between the PHODA-SeV and changes in the TSK and FABQ were considered low, and the receiver operating characteristic curve analyses revealed an area under the curve lower than the proposed threshold of 0.70. Conclusion The PHODA-SeV is a reliable tool that can detect changes over time in pain-related fear in patients with chronic LBP undergoing physical therapy treatment. This tool, however, failed to identify those patients who did or did not improve, according to other pain-related fear measures. J Orthop Sports Phys Ther 2018;48(9):719-727. Epub 23 May 2018. doi:10.2519/jospt.2018.7864.

Cross-cultural adaptation and measurement properties testing of the Iconographical Falls Efficacy Scale (Icon-FES).

BACKGROUND: The Iconographical Falls Efficacy Scale (Icon-FES) is an innovative tool to assess concern of falling that uses pictures as visual cues to provide more complete environmental contexts. Advantages of Icon-FES over previous scales include the addition of more demanding balance-related activities, ability to assess concern about falling in highly functioning older people, and its normal distribution. OBJECTIVE: To perform a cross-cultural adaptation and to assess the measurement properties of the 30-item and 10-item Icon-FES in a community-dwelling Brazilian older population. METHODS: The cross-cultural adaptation followed the recommendations of international guidelines. We evaluated the measurement properties (i.e. internal consistency, test-retest reproducibility, standard error of the measurement, minimal detectable change, construct validity, ceiling/floor effect, data distribution and discriminative validity), in 100 community-dwelling people aged ≥60 years. RESULTS: The 30-item and 10-item Icon-FES-Brazil showed good internal consistency (alpha and omega >0.70) and excellent intra-rater reproducibility (ICC2,1=0.96 and 0.93, respectively). According to the standard error of the measurement and minimal detectable change, the magnitude of change needed to exceed the measurement error and variability were 7.2 and 3.4 points for the 30-item and 10-item Icon-FES, respectively. We observed an excellent correlation between both versions of the Icon-FES and Falls Efficacy Scale - International (rho=0.83, p<0.001 [30-item version]; 0.76, p<0.001 [10-item version]). Icon-FES versions showed normal distribution, no floor/ceiling effects and were able to discriminate between groups relating to fall risk factors. CONCLUSION: Icon-FES-Brazil is a semantically and linguistically appropriate tool with acceptable measurement properties to evaluate concern about falling among the community-dwelling older population.

Physical activity in older people - Case studies of how to make change happen.

Enhancing physical activity (PA) is recognized as a powerful intervention for the prevention and treatment of chronic diseases and disability in older people. Furthermore, there is an agreement that increased PA in daily life is a key determinant of active and healthy ageing and should be recommended for frail and sedentary older people. Unfortunately, relatively few older people engage in regular PA or stay active in the long term. This article summarizes and discusses PA recommendations for older adults without focussing on specific diseases, presents the main barriers and facilitators for increasing PA levels, and considers the implementation of these recommendations on the basis of the existing evidence. Finally, we provide case studies of PA programmes for older people that were successfully implemented and highlight the current lessons learned.

The quality of clinical practice guidelines for chronic respiratory diseases and the reliability of the AGREE II: an observational study.

OBJECTIVES: To survey the quality of evidence-based clinical practice guidelines for chronic respiratory diseases relevant to physiotherapy practice using the Appraisal of Guidelines for Research and Evaluation version II instrument (AGREE II) and to evaluate the inter-rater reliability of AGREE II. DESIGN: Observational survey. PROCEDURES: Guidelines indexed in the Physiotherapy Evidence Database (PEDro) on chronic respiratory diseases were evaluated by four assessors using AGREE II. MAIN OUTCOME MEASURES: The six domains and two global items of AGREE II. RESULTS: Thirty-three guidelines were evaluated (58% were published in the last 5 years and 36% were for chronic obstructive pulmonary disease). The domains with the highest scores were scope and purpose (79%, SD 10%) and clarity of presentation (79%, SD 10%). The domain with the lowest score was applicability (37%, SD 23%). Mean overall quality was five out of seven (SD 1). Intraclass correlation coefficients ranged from 0.66 to 0.93 for the six domains and first global item, suggesting good to excellent reliability. The second global item had very poor reliability (Kappa 0.097). CONCLUSION: The quality of evidence-based clinical practice guidelines for chronic respiratory diseases relevant to physiotherapy could be improved, particularly in consideration with applicability. The number of assessors for AGREE II could be reduced because of the good inter-rater reliability.

How big does the effect of an intervention have to be? Application of two novel methods to determine the smallest worthwhile effect of a fall prevention programme: a study protocol.

INTRODUCTION: This project concerns the identification of the smallest worthwhile effect (SWE) of exercise-based programmes to prevent falls in older people. The SWE is the smallest effect that justifies the costs, risks and inconveniences of an intervention and is used to inform the design and interpretation of systematic reviews and randomised clinical trials. METHODS AND ANALYSIS: This study will comprise two different methodological approaches: the benefit-harm trade-off method and the discrete choice experiment to estimate the SWE of exercise interventions to prevent falls in older people. In the benefit-harm trade-off method, hypothetical scenarios with the benefits, costs, risks and inconveniences associated with the intervention will be presented to each participant. Then, assuming a treatment effect of certain magnitude, the participant will be asked if he or she would choose to have the intervention. The size of the hypothetical benefit will be varied up and down until it is possible to identify the SWE for which the participant would choose to have the intervention. In the discrete choice experiment, the same attributes (benefits, costs, risks and inconveniences) with varying levels will be presented as choice sets, and participants will be asked to choose between these choice sets. With this approach, we will determine the probability that a person will consider the effects of an intervention to be worthwhile, given the particular costs, risks and inconveniences. For each of the two approaches, participants will be interviewed in person and on different occasions. A subsample of the total cohort will participate in both interviews. ETHICS AND DISSEMINATION: This project has received Ethics Approval from the University of Sydney Human Ethics Committee (Protocol number: 14404). Findings will be disseminated through conference presentations, seminars and peer-reviewed scientific journals.

The effect of lumbar posture on abdominal muscle thickness during an isometric leg task in people with and without non-specific low back pain.

This study investigated the effect of lumbar posture on function of transversus abdominis (TrA) and obliquus internus (OI) in people with and without non-specific low back pain (LBP) during a lower limb task. Rehabilitative ultrasound was used to measure thickness change of TrA and OI during a lower limb task that challenged the stability of the spine. Measures were taken in supine in neutral and flexed lumbar postures in 30 patients and 30 healthy subjects. Data were analysed using a two-way (groups, postures) ANOVA. Our results showed that lumbar posture influenced percent thickness change of the TRA muscle but not for OI. An interaction between group and posture was found for TrA thickness change (F(1,56) = 6.818, p = 0.012). For this muscle, only healthy participants showed greater thickness change with neutral posture compared to flexed (mean difference = 6.2%; 95% CI: 3.1-9.3%; p < 0.001). Comparisons between groups for both muscles were not significant. Neutral lumbar posture can facilitate an increase in thickness of the TrA muscle while performing a leg task, however this effect was not observed for this muscle in patients with LBP. No significant difference in TrA and OI thickness change between people with and without non-specific LBP was found.

Fatores limitadores à reabilitação da musculatura do assoalho pélvico em pacientes com incontinência urinária de esforço / Limiting factors in pelvic floor rehabilitation of patients with stress urinary incontinence

A reabilitação da musculatura do assoalho pélvico tem sido preconizada por diversos autores como uma terapia de primeira linha para o tratamento da incontinência urinária de esforço. Apresenta vantagens por ser não invasiva, de baixo custo e sem efeitos colaterais. Porém, fatores como aderência, motivação, compreensão da terapia e deficiência esfincteriana podem interferir nos resultados dessa abordagem terapêutica. A fim de se conhecer o impacto dos fatores citados acima e se investigar o efeito de cada um destes na intervenção fisioterápica foi feita uma revisão da literatura.

The rehabilitation of the pelvic floor muscles has been postulated by many authors as a first-line therapy for the treatment of stress urinary incontinence. It has advantages, such as being a non-invasive, low-cost therapy without side effects. However, factors such as adherence, motivation, therapy understanding and intrinsic sphincter deficiency can interfere with the results of this therapeutic approach. A literature review was carried out to understand the impact of aforementioned factors and investigate the effect of each one of them on the physical therapy intervention.