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INTRODUCTION: Through interviews with 148 older persons from four countries and in four languages, the content for a 17-item measure of active living was developed. The purpose of this paper is to present further evidence of the extent to which this new measure, Older Persons Active Living (OPAL), is "fit-for-purpose" for measuring the extent of active living at one point in time. METHODS: A cross-sectional study was carried out on a population aged 65 + and living independently, drawn from a participant panel, HostedinCanada, sampling people from Canada, United States, United Kingdom, and Netherlands. The survey instrument comprised the OPAL questionnaire rated on importance and frequency, sociodemographics, and information on physical and mental function. The argument-based approach to validity framed the analyses. Logistic regression, structural equation modeling, ordinary least-squares regression, and correlation were used to generate estimates for parameters underpinning validity evidence. RESULTS: A total of 1612 people completed the survey, 100 to 400 people across the 6 country-language strata. The proportion of people rating the items as extremely or quite important ranged from 60 to 90%, with no important differences between men and women and few differences between strata. A single-factor structure was supported. The ordinality of the response options justified an additive total score yielding a near normal distribution (mean: 33.1; SD: 11.5; range 0-51). Correlations with other measures of converging constructs were of moderate strength (~ 0.50), and differences across groups known to affect functioning and health were observed, suggesting a Miminal Important Difference (MID) of 6 out of 51. CONCLUSION: The results of this study provide evidence that the 17-item OPAL measure is fit for the purpose of estimating the extent to which older persons are living actively at one point in time.
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AIMS: Many older persons do not think of themselves as "patients" but as persons wishing to live as actively as possible for as long as possible. However, most health-related quality of life (HRQL) measures were developed for use with clinical populations. The aim of this project was to fill that gap and to develop, for international use, a measure of what matters to older persons as they age and seek to remain as active as possible, Older Persons for Active Living (OPAL). METHODS: For content development, interviews about active living were conducted with older persons from Canada, USA, UK, and the Netherlands in English, French, Spanish and Dutch, respectively with subsequent thematic analysis and harmonization. RESULTS: Analyses of transcripts from 148 older persons revealed that active living was a "way of being" and not merely doing activities. Saturation was reached and a total of 59 content areas were identified. After grouping similar "ways" together and after conducting a consensus rating of importance, 19 unique and important "ways" remained. In some languages, formulating was challenging for three of the 19, resulting in changes to two English words and dropping two other words, yielding a final list of 17 "ways of being" with harmonized wording in 4 languages. CONCLUSION: This study underscores the significance of listening to older adults and highlights the importance of considering linguistic and cultural nuances in measure development.
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BACKGROUND: There are health and well-being benefits of community ambulation; however, many older adults do not regularly walk outside of their home. Objectives were to estimate the associations between latent constructs related to community ambulation in older adults aged 65-85 (65+), and in adults with osteoarthritis (OA) aged 45-85. METHODS: Secondary data analysis of the comprehensive baseline and maintaining contact questionnaire data from the Canadian Longitudinal Study of Aging (CLSA) was completed. Based on a previous model of community ambulation post-stroke, structural equation modeling (SEM) was used to develop measurement and structural models for two groups: older adults 65+ and people with OA. Multi-group SEM was conducted to test measurement invariance across sex and age groups. Measurement models were developed for the following latent factors: ambulation (frequency of walking outside/week, hours walked/day, ability to walk without help, frequency and aids used in different settings); health perceptions (general health, pain frequency/intensity); timed functional mobility (gait speed, timed up-and-go, sit-to-stand, balance). Variables of depression, falls, age, sex, and fear of walking alone at night were covariates in the structural models. RESULTS: Data were used from 11,619 individuals in the 65+ group (mean age 73 years ±6, 49% female) and 5546 individuals in the OA group (mean age 67 ± 10, 60% female). The final 65+ model had a close fit with RMSEA (90% CI) = 0.018 (0.017, 0.019), CFI = 0.91, SRMR = 0.09. For the OA group, RMSEA (90% CI) = 0.021 (0.020, 0.023), CFI = 0.92, SRMR = 0.07. Health perceptions and timed functional mobility had a positive association with ambulation. Depression was associated with ambulation through negative associations with health perceptions and timed functional mobility. Multi-group SEM results reveal the measurement model was retained for males and females in the 65+ group, for males and females and for age groups (65+, < 65) in the OA group. CONCLUSIONS: The community ambulation model post-stroke was verified with adults aged 65+ and for those with OA. The models of community ambulation can be used to frame and conceptualize community ambulation research and clinical interventions.
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Osteoartritis , Accidente Cerebrovascular , Masculino , Humanos , Femenino , Anciano , Canadá/epidemiología , Estudios Longitudinales , Caminata , Envejecimiento , Osteoartritis/diagnóstico , Osteoartritis/epidemiologíaRESUMEN
BACKGROUND: Mobility within and between life spaces is fundamental for health and well-being. Our objective was to verify a comprehensive framework for mobility. METHODS: This was a cross-sectional study. We used structural equation modeling to estimate associations between latent factors with data from the Canadian Longitudinal Study on Aging for participants 65-85 years of age (65+, n = 11,667) and for adults with osteoarthritis (OA) aged 45-85 (n = 5,560). Latent factors included life space mobility, and physical, psychosocial, environmental, financial, and cognitive elements. Personal variables (age, sex, education) were covariates. RESULTS: The models demonstrated good fit (65+: CFI = 0.90, RMSEA (90% CI) = 0.025 (0.024, 0.026); OA: CFI = 0.90, RMSEA (90% CI) = 0.032 (0.031, 0.033)). In both models, better psychosocial and physical health, and being less afraid to walk after dark (observed environmental variable) were associated with greater life space mobility. Greater financial status was associated with better psychosocial and physical health. Higher education was related to better cognition and finances. Older age was associated with lower financial status, cognition, and physical health. Cognitive health was positively associated with greater mobility only in the 65 + model. Models generated were equivalent for males and females. CONCLUSIONS: Associations between determinants described in the mobility framework were verified with adults 65-85 years of age and in an OA group when all factors were considered together using SEM. These results have implications for clinicians and researchers in terms of important outcomes when assessing life space mobility; findings support interdisciplinary analyses that include evaluation of cognition, depression, anxiety, environmental factors, and community engagement, as well as physical and financial health. Public policies that influence older adults and their abilities to access communities beyond their homes need to reflect the complexity of factors that influence life space mobility at both individual and societal levels.
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Envejecimiento , Masculino , Femenino , Humanos , Anciano , Anciano de 80 o más Años , Estudios Longitudinales , Estudios Transversales , Análisis de Clases Latentes , Canadá/epidemiologíaRESUMEN
BACKGROUND: Process evaluations of randomized controlled trials (RCTs) of community exercise programs are important to help explain the results of a trial and provide evidence of the feasibility for community implementation. The objectives of this process evaluation for a multi-centre RCT of outdoor walking interventions for older adults with difficulty walking outdoors, were to determine: 1) implementation fidelity (the extent to which elements of the intervention were delivered as specified in the original protocol) and 2) participant engagement (the receipt of intervention components by the participants) in the Getting Older Adults Outdoors (GO-OUT) trial. METHODS: GO-OUT participants attended an active 1-day workshop designed to foster safe, outdoor walking skills. After the workshop, 190 people at 4 sites were randomized to an outdoor walk group (OWG) (n = 98) which met 2x/week for 10 weeks, or the weekly reminders (WR) group (n = 92) which received a phone reminder 1x/week for 10 weeks. The OWG had 5 components - warm-up, continuous distance walk, task-oriented walking activities, 2nd continuous distance walk, and cool-down. Data on implementation fidelity and participant engagement were gathered during the study through site communications, use of standardized forms, reflective notes of the OWG leaders, and accelerometry and GPS assessment of participants during 2 weeks of the OWG. RESULTS: All sites implemented the workshop according to the protocol. Participants were engaged in all 8 activity stations of the workshop. WR were provided to 96% of the participants in the WR intervention group. The 5 components of the OWG sessions were implemented in over 95% of the sessions, as outlined in the protocol. Average attendance in the OWG was not high - 15% of participants did not attend any sessions and 64% of participants in the OWG attended > 50% of the sessions. Evaluations with accelerometry and GPS during week 3 and 9 OWG sessions suggest that participants who attended were engaged and active during the OWG. CONCLUSIONS: This process evaluation helps explain the main study findings and demonstrates the flexibility required in the protocol for safe and feasible community implementation. Future research could explore the use of additional behaviour change strategies to optimize attendance for community implementation. TRIAL REGISTRATION: ClinicalTrials.gov NCT03292510 Date of registration: September 25, 2017.
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Limitación de la Movilidad , Caminata , Anciano , Humanos , Ejercicio Físico , Terapia por Ejercicio/métodosRESUMEN
This study aimed to inform a measurement approach for older persons who wish to engage in active living such as participating in a walking program. The Patient Generated Index, an individualized measurement approach, and directed and summative content analyses were carried out. A sample size of 204 participants (mean age 75 years; 62% women) was recruited; it generated 934 text threads mapped to 460 unique categories within 45 domains with similarities and differences for women and men. The Capability, Opportunity, Motivation, and Behaviors Model best linked the domains. The results suggest that older persons identify the need to overcome impaired capacity, low motivation, and barriers to engagement to live actively. These are all areas that active living programs could address. How to measure the outcomes of these programs remains elusive.
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Vida Independiente , Calidad de Vida , Masculino , Humanos , Femenino , Anciano , Anciano de 80 o más Años , MotivaciónRESUMEN
PURPOSE: Item non-response (i.e., missing data) may mask the detection of differential item functioning (DIF) in patient-reported outcome measures or result in biased DIF estimates. Non-response can be challenging to address in ordinal data. We investigated an unsupervised machine-learning method for ordinal item-level imputation and compared it with commonly-used item non-response methods when testing for DIF. METHODS: Computer simulation and real-world data were used to assess several item non-response methods using the item response theory likelihood ratio test for DIF. The methods included: (a) list-wise deletion (LD), (b) half-mean imputation (HMI), (c) full information maximum likelihood (FIML), and (d) non-negative matrix factorization (NNMF), which adopts a machine-learning approach to impute missing values. Control of Type I error rates were evaluated using a liberal robustness criterion for α = 0.05 (i.e., 0.025-0.075). Statistical power was assessed with and without adoption of an item non-response method; differences > 10% were considered substantial. RESULTS: Type I error rates for detecting DIF using LD, FIML and NNMF methods were controlled within the bounds of the robustness criterion for > 95% of simulation conditions, although the NNMF occasionally resulted in inflated rates. The HMI method always resulted in inflated error rates with 50% missing data. Differences in power to detect moderate DIF effects for LD, FIML and NNMF methods were substantial with 50% missing data and otherwise insubstantial. CONCLUSION: The NNMF method demonstrated comparable performance to commonly-used non-response methods. This computationally-efficient method represents a promising approach to address item-level non-response when testing for DIF.
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Medición de Resultados Informados por el Paciente , Calidad de Vida , Simulación por Computador , Humanos , Funciones de Verosimilitud , Psicometría/métodos , Calidad de Vida/psicologíaRESUMEN
PURPOSE: Strongly framed research questions are clear as to the population (P), the exposures or interventions (E/I), comparison groups (C), outcomes (O), time when relevant (T), and what the investigator wants to know. A solid framework sets up the measurement model, analysis, and anticipated results. The purpose of this study was to estimate the extent to which research questions in journals that focused on patient-reported outcome measures (PROM) and quality of life (QOL) are clear. METHODS: All 440 research articles published in four PROM journals in 2020. excluding reviews, psychometric, and qualitative papers, were reviewed. Research questions were classified as: (i) adequately framed (ii) poorly framed; or (iii) unframed based on clarity criteria. Examples from each journal were presented and reframed to match results in the article. RESULTS: Of 440 articles, 195 (44.3%) were classified as adequately framed; 230 (52.2%) as poorly framed; and 15 (3.4%) as unframed. There was heterogeneity across journals (Chi-square: 20.8; 6 df; p = 0.002). Only 29% were framed according to what the investigators wanted to know; 72% were framed like a "to do" list; and 6% were framed as a research agenda. CONCLUSION: Almost half of the questions were poorly framed or unframed a practice that could contribute to research wastage. Even "adequately framed" questions rarely stated what they wanted to know a priori, increasing the risk of biased reporting. Researchers, reviewers, and editors should encourage the use established frameworks for research questions.
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Calidad de Vida , Humanos , Psicometría , Calidad de Vida/psicologíaRESUMEN
Safety guidelines resulting from the coronavirus disease 2019 pandemic may reduce physical activity participation of older adults, particularly prefrail and frail individuals. The objective was to explore older adults' experiences with physical activity during the coronavirus disease 2019 pandemic. Using a qualitative descriptive approach, interviews were conducted with 16 older adults. Data were analyzed thematically. Two themes emerged: (a) coming to a standstill and (b) small steps. Participants described that imposed provincial and federal recommendations caused them to reduce their physical activity with negative consequences. As time progressed, participants used emerging public health knowledge about coronavirus disease 2019 to safely increase physical activity. Many participants developed strategies to remain active during the pandemic (e.g., wearing a pedometer, walking outdoors at particular times of day). Findings from this study can better inform the development of programs, clinical practice, and policy for physical activity promotion in older adults during periods of physical distancing and isolation.
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COVID-19 , Actigrafía , Anciano , COVID-19/prevención & control , Ejercicio Físico , Humanos , Salud Pública , CaminataRESUMEN
Limited community ambulation, defined as independent mobility outside the home, predicts adverse outcomes in older adults. We performed a systematic review and meta-analysis to examine outdoor community ambulation intervention effectiveness in older adults. We searched six databases until October 2021. Studies with an evaluative research objective, older adult population, and outdoor community ambulation interventions were eligible. After reviewing 23,172 records, five studies were included. The meta-analysis found no significant difference in walking endurance and depression outcomes between outdoor community ambulation and comparison interventions. For outcomes not suitable for meta-analysis, studies showed no significant difference in walking activity, anxiety, and general and health-related quality of life, and possible improvements in gait speed and lower extremity function and strength. Most evidence was of low to very low certainty. Considering the limited evidence base, the design, implementation, and evaluation of outdoor community ambulation interventions in older adults should be prioritized in primary research.
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Salud Mental , Calidad de Vida , Humanos , Anciano , CaminataRESUMEN
PURPOSE: Results of patient-reported outcome measures (PROMs) are increasingly used to inform healthcare decision-making. Research has shown that response shift can impact PROM results. As part of an international collaboration, our goal is to provide a framework regarding the implications of response shift at the level of patient care (micro), healthcare institute (meso), and healthcare policy (macro). METHODS: Empirical evidence of response shift that can influence patients' self-reported health and preferences provided the foundation for development of the framework. Measurement validity theory, hermeneutic philosophy, and micro-, meso-, and macro-level healthcare decision-making informed our theoretical analysis. RESULTS: At the micro-level, patients' self-reported health needs to be interpreted via dialogue with the clinician to avoid misinterpretation of PROM data due to response shift. It is also important to consider the potential impact of response shift on study results, when these are used to support decisions. At the meso-level, individual-level data should be examined for response shift before aggregating PROM data for decision-making related to quality improvement, performance monitoring, and accreditation. At the macro-level, critical reflection on the conceptualization of health is required to know whether response shift needs to be controlled for when PROM data are used to inform healthcare coverage. CONCLUSION: Given empirical evidence of response shift, there is a critical need for guidelines and knowledge translation to avoid potential misinterpretations of PROM results and consequential biases in decision-making. Our framework with guiding questions provides a structure for developing strategies to address potential impacts of response shift at micro-, meso-, and macro-levels.
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Medición de Resultados Informados por el Paciente , Calidad de Vida , Atención a la Salud , Política de Salud , Humanos , Mejoramiento de la Calidad , Calidad de Vida/psicologíaRESUMEN
The aim of this study was to examine the construct and known-groups validity of the total score of five items adapted from the Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire to measure outdoor walking (CHAMPS-OUTDOORS) in older adults. Data from the baseline assessment of the Getting Older Adult OUTdoors (GO-OUT) trial were used. Construct validity of the CHAMPS-OUTDOORS used objective measures of outdoor walking (accelerometry-GPS), Ambulatory Self-Confidence Questionnaire, RAND-36, 6-min walk test, 10-m walk test, and Mini-Balance Evaluation System Test. For known-groups validity, we compared the CHAMPS-OUTDOORS of those who walked < or ≥1.2 m/s. Sixty-five participants had an average age of 76.5 ± 7.8 years. The CHAMPS-OUTDOORS was moderately correlated with total outdoor walking time (r = .33) and outdoor steps (r = .33) per week measured by accelerometry-GPS, and weakly correlated with Mini-Balance Evaluation System Test score (r = .27). The CHAMPS-OUTDOORS did not distinguish known groups based on crosswalk speed (p = .33). The CHAMPS-OUTDOORS may be used to assess outdoor walking in the absence of accelerometry GPS. Further research examining reliability is needed.
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Estado de Salud , Caminata , Acelerometría , Anciano , Anciano de 80 o más Años , Humanos , Reproducibilidad de los Resultados , Encuestas y CuestionariosRESUMEN
BACKGROUND: Stroke is caused by the interruption of blood flow to the brain (ischemic stroke) or the rupture of blood vessels within the brain (hemorrhagic stroke) and may lead to changes in perception, cognition, mood, speech, health-related quality of life, and function, such as difficulty walking and using the arm. Activity limitations (decreased function) of the upper extremity are a common finding for individuals living with stroke. Mental practice (MP) is a training method that uses cognitive rehearsal of activities to improve performance of those activities. OBJECTIVES: To determine whether MP improves outcomes of upper extremity rehabilitation for individuals living with the effects of stroke. In particular, we sought to (1) determine the effects of MP on upper extremity activity, upper extremity impairment, activities of daily living, health-related quality of life, economic costs, and adverse effects; and (2) explore whether effects differed according to (a) the time post stroke at which MP was delivered, (b) the dose of MP provided, or (c) the type of comparison performed. SEARCH METHODS: We last searched the Cochrane Stroke Group Trials Register on September 17, 2019. On September 3, 2019, we searched the Cochrane Central Register of Controlled Trials (the Cochrane Library), MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, Scopus, Web of Science, the Physiotherapy Evidence Database (PEDro), and REHABDATA. On October 2, 2019, we searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform. We reviewed the reference lists of included studies. SELECTION CRITERIA: We included randomized controlled trials (RCTs) of adult participants with stroke who had deficits in upper extremity function (called upper extremity activity). DATA COLLECTION AND ANALYSIS: Two review authors screened titles and abstracts of the citations produced by the literature search and excluded obviously irrelevant studies. We obtained the full text of all remaining studies, and both review authors then independently selected trials for inclusion. We combined studies when the review produced a minimum of two trials employing a particular intervention strategy and a common outcome. We considered the primary outcome to be the ability of the arm to be used for appropriate tasks, called upper extremity activity. Secondary outcomes included upper extremity impairment (such as quality of movement, range of motion, tone, presence of synergistic movement), activities of daily living (ADLs), health-related quality of life (HRQL), economic costs, and adverse events. We assessed risk of bias in the included studies and applied GRADE to assess the certainty of the evidence. We completed subgroup analyses for time since stroke, dosage of MP, type of comparison, and type of arm activity outcome measure. MAIN RESULTS: We included 25 studies involving 676 participants from nine countries. For the comparison of MP in addition to other treatment versus the other treatment, MP in combination with other treatment appears more effective in improving upper extremity activity than the other treatment without MP (standardized mean difference [SMD] 0.66, 95% confidence interval [CI] 0.39 to 0.94; I² = 39%; 15 studies; 397 participants); the GRADE certainty of evidence score was moderate based on risk of bias for the upper extremity activity outcome. For upper extremity impairment, results were as follows: SMD 0.59, 95% CI 0.30 to 0.87; I² = 43%; 15 studies; 397 participants, with a GRADE score of moderate, based on risk of bias. For ADLs, results were as follows: SMD 0.08, 95% CI -0.24 to 0.39; I² = 0%; 4 studies; 157 participants; the GRADE score was low due to risk of bias and small sample size. For the comparison of MP versus conventional treatment, the only outcome with available data to combine (3 studies; 50 participants) was upper extremity impairment (SMD 0.34, 95% CI -0.33 to 1.00; I² = 21%); GRADE for the impairment outcome in this comparison was low due to risk of bias and small sample size. Subgroup analyses of time post stroke, dosage of MP, or comparison type for the MP in combination with other rehabilitation treatment versus the other treatment comparison showed no differences. The secondary outcome of health-related quality of life was reported in only one study, and no study noted the outcomes of economic costs and adverse events. AUTHORS' CONCLUSIONS: Moderate-certainty evidence shows that MP in addition to other treatment versus the other treatment appears to be beneficial in improving upper extremity activity. Moderate-certainty evidence also shows that MP in addition to other treatment versus the other treatment appears to be beneficial in improving upper extremity impairment after stroke. Low-certainty evidence suggests that ADLs may not be improved with MP in addition to other treatment versus the other treatment. Low-certainty evidence also suggests that MP versus conventional treatment may not improve upper extremity impairment. Further study is required to evaluate effects of MP on time post stroke, the volume of MP required to affect outcomes, and whether improvement is maintained over the long term.
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Brazo , Imaginación/fisiología , Paresia/rehabilitación , Práctica Psicológica , Rehabilitación de Accidente Cerebrovascular/métodos , Accidente Cerebrovascular/complicaciones , Terapia Combinada/métodos , Femenino , Humanos , Masculino , Paresia/etiología , Ensayos Clínicos Controlados Aleatorios como Asunto , Recuperación de la FunciónRESUMEN
OBJECTIVE: To estimate, among people with multiple sclerosis, the extent to which a personally tailored exercise programme (MSTEP©) resulted in greater improvements in exercise capacity and related outcomes over 12 months in comparison with general exercise guidelines. DESIGN: Two-group randomized trial. SUBJECTS: Ambulatory and sedentary. INTERVENTIONS: MSTEP©, a personally adapted exercise regimen done on most days including two days of high intensity exercise; guidelines recommending 30 minutes of moderate intensity aerobic and strength training two times per week. MAIN MEASURES: Primary outcome was peak oxygen consumption (VO2peak) at 12 months; secondary outcomes were composite measures of physical function, fatigue, and health-related quality of life. RESULTS: In total, 137 people were randomized, 66 were lost over 12 months leaving 71 with outcome data, 34 in MSTEP© group, and 37 in the Guideline group. Exercise enjoyment and confidence and exercise-induced fatigue predicted retention. There were no differences between groups on the proportion making a 10% increase in VO2peak (27.1% MSTEP© vs 29.6% Guidelines; OR: 0.83; 95% CI: 0.23-3.08) by the 12 month assessment. The effect on fatigue was larger in the MSTEP© group than the Guideline groups (OR: 1.59; 95% CI: 0.93-2.74), the effect on physical function was more modest (OR: 1.35; 95% CI: 0.80-2.25), and null for health-related quality of life outcomes. CONCLUSIONS: The disappointing exercise retention suggests that people with multiple sclerosis may not consider exercise important to their brain health. Either type of exercise resulted in stable exercise capacity over 1 year in those sticking with the programme.
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Terapia por Ejercicio , Esclerosis Múltiple/psicología , Esclerosis Múltiple/rehabilitación , Cooperación del Paciente , Adulto , Tolerancia al Ejercicio , Femenino , Humanos , Masculino , Persona de Mediana Edad , Esclerosis Múltiple/fisiopatología , Pacientes Desistentes del Tratamiento , Calidad de Vida , Resultado del TratamientoRESUMEN
OBJECTIVE: To determine the optimal threshold, based on cadence and lifestyle counts per minute, to detect outdoor walking in mobility-limited older adults. METHODS: Older adults (N = 25, median age: 77.0 years, interquartile range: 10.5) wore activity monitors during 80 outdoor walks. Walking bouts were identified manually (reference standard) and compared with identification using cadence thresholds (≥30, ≥35, ≥40, ≥45, and ≥50 steps/min) and >760 counts per minute using low frequency extension analysis. RESULTS: Median walking bout duration was 10.5 min (interquartile range 4.8) and median outdoor walking speed was 0.70 m/s (interquartile range 0.20). Cadence thresholds of ≥30, ≥35, and ≥40 steps/min demonstrated high sensitivity (1.0, 95% confidence intervals [0.95, 1.0]) to detect walking bouts; estimates for specificity and positive predictive value were highest for ≥40 steps/min. CONCLUSION: A cadence threshold of ≥40 steps/min is recommended for detecting sustained outdoor walking in this population.
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Research in rehabilitation has grown from a rare phenomenon to a mature science and clinical trials are now common. The purpose of this study is to estimate the extent to which questions posed and methods applied in clinical trials published in Clinical Rehabilitation have evolved over three decades with respect to accepted standards of scientific rigour. Studies were identified by journal, database, and hand searching for the years 1986 to 2016.A total of 390 articles whose titles suggested a clinical trial of an intervention, with or without randomization to form groups, were reviewed. Questions often still focused on methods to be used (57%) rather than what knowledge was to be gained. Less than half (43%) of the studies delineated between primary and secondary outcomes; multiple outcomes were common; and sample sizes were relatively small (mean 83, range 5 to 3312). Blinding of assessors was common (72%); blinding of study subjects was rare (19%). In less than one-third of studies was intention-to-treat analysis done correctly; power was reported in 43%. There is evidence of publication bias as 83% of studies reported either a between-group or a within-group effect. Over time, there was an increase in the use of parameter estimation rather than hypothesis testing and there was evidence that methodological rigour improved.Rehabilitation trialists are answering important questions about their interventions. Outcomes need to be more patient-centred and a measurement framework needs to be explicit. More advanced statistical methods are needed as interventions are complex. Suggestions for moving forward over the next decades are given.
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Investigación Biomédica/tendencias , Ensayos Clínicos como Asunto , Publicaciones Periódicas como Asunto/tendencias , Edición/tendencias , Rehabilitación/tendencias , HumanosRESUMEN
BACKGROUND: Community ambulation refers to the ability of a person to walk in their own community, outside of their home and also indoors in private or public locations. Some people choose to walk for exercise or leisure and may walk with others as an important aspect of social functioning. Community ambulation is therefore an important skill for stroke survivors living in the community whose walking ability has been affected. OBJECTIVES: To determine: (1) whether interventions improve community ambulation for stroke survivors, and (2) if any specific intervention method improves community ambulation more than other interventions. SEARCH METHODS: We searched the Cochrane Stroke Group Trials Register (September 2014), the Cochrane Central Register of Controlled Trials (CENTRAL) (November 2013), PubMed (1946 to November 2013), EMBASE (1980 to November 2013), CINAHL (1982 to November 2013), PsycINFO (1887 to November 2013), Scopus (1960 to November 2013), Web of Science (1900 to November 2013), SPORTDiscus (1975 to November 2013), and PEDro, CIRRIE and REHABDATA (November 2013). We also searched ongoing trials registers (November 2013) and reference lists, and performed a cited reference search. SELECTION CRITERIA: Selection criteria included parallel-group randomised controlled trials (RCTs) and cross-over RCTs, studies in which participants are adult (aged 18 years or more) stroke survivors, and interventions that were aimed at improving community ambulation. We defined the primary outcome as participation; secondary outcomes included activity level outcomes related to gait and self-efficacy. DATA COLLECTION AND ANALYSIS: One review author independently screened titles. Two review authors screened abstracts and full text articles, with a third review author was available to resolve any disagreements. Two review authors extracted data and assessed risk of bias. All outcomes were continuous. The analysis for the primary outcome used the generic inverse variance methods for meta-analysis, using the standardised mean difference (SMD) and standard error (SE) from the participation outcomes. Analyses for secondary outcomes all used SMD or mean difference (MD). We completed analyses for each outcome with all studies, and by type of community ambulation intervention (community or outdoor ambulation practice, virtual practice, and imagery practice). We considered trials for each outcome to be of low quality due to some trial design considerations, such as who knew what group the participants were in, and the number of people who dropped out of the studies. MAIN RESULTS: We included five studies involving 266 participants (136 intervention; 130 control). All participants were adult stroke survivors, living in the community or a care home. Programmes to improve community ambulation consisted of walking practice in a variety of settings and environments in the community, or an indoor activity that mimicked community walking (including virtual reality or mental imagery). Three studies were funded by government agencies, and two had no funding.From two studies of 198 people there was low quality evidence for the effect of intervention on participation compared with control (SMD, 0.08, 95% confidence interval (CI) -0.20 to 0.35 (using inverse variance). The CI for the effect of the intervention on gait speed was wide and does not exclude no difference (MD 0.12, 95% CI -0.01 to 0.24; four studies, 98 participants, low quality evidence). We considered the quality of the evidence to be low for all the remaining outcomes in our review: Community Walk Test (MD -6.35, 95% CI -21.59 to 8.88); Walking Ability Questionnaire (MD 0.53, 95% CI -5.59 to 6.66); Six-Minute Walk Test (MD 39.62 metres, 95% CI -8.26 to 87.51) and self-efficacy (SMD 0.32, 95% CI -0.09 to 0.72). We downgraded the quality of the evidence because of a high risk of bias and imprecision. AUTHORS' CONCLUSIONS: There is currently insufficient evidence to establish the effect of community ambulation interventions or to support a change in clinical practice. More research is needed to determine if practicing outdoor or community walking will improve participation and community ambulation skills for stroke survivors living in the community.
Asunto(s)
Rehabilitación de Accidente Cerebrovascular , Caminata/fisiología , Actividades Cotidianas , Adulto , Planificación Ambiental , Marcha/fisiología , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto , Características de la Residencia , Autoeficacia , Factores de TiempoRESUMEN
OBJECTIVE: To develop a model of community ambulation after stroke based on: Canadian data from community-dwelling individuals post-stroke; the experiences and opportunities for community ambulation expressed by individuals with stroke; and current literature. The model presents a visual depiction of the relationships between the different factors of community ambulation after stroke. DESIGN: A quantitative/qualitative explanatory sequential mixed-methods design was utilized. Secondary data analysis with structural equation modeling resulted in a community ambulation model. Two focus groups of individuals with stroke were conducted to verify and explain the model. SETTING: Community. SUBJECTS: Quantitative data from 227 participants: 142 (63%) male; 63.4 (12.0) years of age and 2.6 (2.5) years post stroke. Eleven individuals participated in the focus groups: 6 (55%) male; 61.4 (6.9) years of age and 5.8 (3.3) years since stroke. MAIN MEASURES: Model variables: items from the EuroQol, Preference Based Stroke Index, gait speed, Reintegration to Normal Living Index, the Community Health Activities Model Program for Seniors, and the Geriatric Depression Scale. RESULTS: The model had reasonable fit with three latent variables: ambulation, gait speed, and health perceptions (normed χ(2)=1.8, root mean square error of approximation = 0.060 (0.043; 0.075)). Depression was also a component of community ambulation. Participants verified the model and added endurance and the environment as additional components. Participants used self-awareness and knowledge of the environment to engage in cognitive strategies related to community ambulation. CONCLUSIONS: A model of community ambulation after stroke was developed and verified. Recognizing important components of community ambulation may assist physiotherapists in determining community ambulation goals, needs, and opportunities in partnership with clients.
Asunto(s)
Características de la Residencia , Rehabilitación de Accidente Cerebrovascular , Caminata , Anciano , Canadá , Emociones , Femenino , Grupos Focales , Humanos , Masculino , Persona de Mediana Edad , Recuperación de la Función , Autoimagen , Medio Social , Accidente Cerebrovascular/fisiopatología , Accidente Cerebrovascular/psicologíaRESUMEN
OBJECTIVE: To enhance participation post stroke through a structured, community-based program. DESIGN: A controlled trial with random allocation to immediate or four-month delayed entry. SETTING: Eleven community sites in seven Canadian cities. SUBJECTS: Community dwelling persons within five years of stroke onset, cognitively intact, able to toilet independently. INTERVENTIONS: Evidence-based program delivered in three 12-week sessions including exercise and project-based activities, done as individuals and in groups. MAIN MEASURES: Hours spent per week in meaningful activities outside of the home and Reintegration to Normal Living Index; Stroke-Specific Geriatric Depression Scale, Apathy Scale, gait speed, EuroQuol EQ-5D, and Preference-Based Stroke Index. All measures were transformed to a scale from 0 to 100. Assessments prior to randomization, after the first session at three months, six months, 12 months, and 15 months. RESULTS: A total of 186 persons were randomized. The between-group analysis showed no disadvantage to waiting and so groups were combined and a within-person analysis was carried out at three time points. There were statistically significant increases in all study outcomes on average over all persons. Over 45% of people met or exceeded the pre-specified target of a three hour per week increase in meaningful activity and this most often took a full year of intervention to achieve. Greatest gains were in satisfaction with community integration (mean 4.78; 95% CI: 2.01 to 7.55) and stroke-specific health-related quality of life (mean 4.14; 95% CI: 2.31 to 5.97). CONCLUSIONS: Community-based programs targeting participation are feasible and effective, but stroke survivors require time to achieve meaningful gains.