TY - JOUR
T1 - Home-based self-management for sedentary individuals with mild walking disability after stroke
T2 - protocol for a randomised pilot study
AU - Alvarenga, Maria Tereza Mota
AU - Ada, Louise
AU - Preston, Elisabeth
AU - Caetano, Lívia Cristina Guimarães
AU - Teixeira-Salmela, Luci Fuscaldi
AU - Scianni, Aline A.
N1 - Funding Information:
This study has been funded by Brazilian Government Funding Agencies: CAPES–code 001, CNPq: 304434/2014–0 and FAPEMIG: APQ-00061–22, and monitoring is supported by the Federal University of Minas Gerais. These government funding bodies are independent and have no role in the design of the study or collection, analysis, and interpretation of data or in writing the manuscript.
Publisher Copyright:
© 2023, The Author(s).
PY - 2023/11
Y1 - 2023/11
N2 - Background: A Phase I study showed that it is feasible to implement a home-based self-management program aimed at increasing physical activity in individuals after stroke with mild walking disability in Brazil. The next step is to test this program against a control group in order to provide a power analysis for a fully-powered Phase III clinical trial. Methods: A Phase II pilot randomised clinical trial with concealed allocation, blinded measurement, and intention-to-treat analyses will be carried out. The inclusion criteria will be individuals diagnosed with stroke, in the acute or subacute phase, with mild walking disability, sedentary, and no significant language impairment. The participants will be randomly allocated to the experimental or control group. The experimental group will receive six sessions of a home-based self-management program based on behaviour change techniques through the Social-Cognitive Theory and Control Theory over 11 weeks. The control group will receive one session of education about stroke (regarding the importance of practising physical activity after a stroke) and usual care. A total of 24 participants will be recruited. The primary outcome will be physical activity, measured through steps taken per day by an activity monitor (Actigraph wGT3X-BT, Pensacola, FL, USA). The mean of daily steps will be analysed to compare groups after intervention. Secondary outcomes will be cardiovascular risk (body mass index, waist circumference, and blood pressure), depressive symptoms (Geriatric Depression Scale), walking ability (6-Minute Walk Test and 10-Meter Walk Test), exercise self-efficacy (Self-Efficacy for Exercise scale), social participation (Stroke Impact Scale) and quality of life (EuroQual-5D). Two-way analyses of variance will be implemented for all parametric outcomes, and the Kruskal–Wallis test for non-parametric outcomes will be used to determine the statistical significance of the between-group differences and reported as mean differences between groups (95% CI). All analyses will be conducted intention-to-treat. All outcomes will be measured at baseline (Week 0), post-intervention (Week 12), and follow-up (Week 24). This pilot clinical trial was registered online at Clinical Trials under number NCT05461976 on 4th April 2022. Discussion: If beneficial, this Phase II pilot randomised trial will provide data to plan a fully powered future Phase III clinical trial aimed at verifying the efficacy of this program to promote physical activity after stroke. Trial registration: Clinical Trials NCT05461976 on 4th April 2022.
AB - Background: A Phase I study showed that it is feasible to implement a home-based self-management program aimed at increasing physical activity in individuals after stroke with mild walking disability in Brazil. The next step is to test this program against a control group in order to provide a power analysis for a fully-powered Phase III clinical trial. Methods: A Phase II pilot randomised clinical trial with concealed allocation, blinded measurement, and intention-to-treat analyses will be carried out. The inclusion criteria will be individuals diagnosed with stroke, in the acute or subacute phase, with mild walking disability, sedentary, and no significant language impairment. The participants will be randomly allocated to the experimental or control group. The experimental group will receive six sessions of a home-based self-management program based on behaviour change techniques through the Social-Cognitive Theory and Control Theory over 11 weeks. The control group will receive one session of education about stroke (regarding the importance of practising physical activity after a stroke) and usual care. A total of 24 participants will be recruited. The primary outcome will be physical activity, measured through steps taken per day by an activity monitor (Actigraph wGT3X-BT, Pensacola, FL, USA). The mean of daily steps will be analysed to compare groups after intervention. Secondary outcomes will be cardiovascular risk (body mass index, waist circumference, and blood pressure), depressive symptoms (Geriatric Depression Scale), walking ability (6-Minute Walk Test and 10-Meter Walk Test), exercise self-efficacy (Self-Efficacy for Exercise scale), social participation (Stroke Impact Scale) and quality of life (EuroQual-5D). Two-way analyses of variance will be implemented for all parametric outcomes, and the Kruskal–Wallis test for non-parametric outcomes will be used to determine the statistical significance of the between-group differences and reported as mean differences between groups (95% CI). All analyses will be conducted intention-to-treat. All outcomes will be measured at baseline (Week 0), post-intervention (Week 12), and follow-up (Week 24). This pilot clinical trial was registered online at Clinical Trials under number NCT05461976 on 4th April 2022. Discussion: If beneficial, this Phase II pilot randomised trial will provide data to plan a fully powered future Phase III clinical trial aimed at verifying the efficacy of this program to promote physical activity after stroke. Trial registration: Clinical Trials NCT05461976 on 4th April 2022.
KW - Behaviour change techniques
KW - Home-based intervention
KW - Physical activity
KW - Pilot clinical trial
KW - Self-management
KW - Stroke
UR - http://www.scopus.com/inward/record.url?scp=85177193505&partnerID=8YFLogxK
U2 - 10.1186/s12883-023-03461-7
DO - 10.1186/s12883-023-03461-7
M3 - Article
C2 - 37986149
AN - SCOPUS:85177193505
SN - 1471-2377
VL - 23
SP - 1
EP - 9
JO - BMC Neurology
JF - BMC Neurology
IS - 1
M1 - 412
ER -