Home-based self-management for sedentary individuals with mild walking disability after stroke: protocol for a randomised pilot study
Abstract 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...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2023-11-01
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| Series: | BMC Neurology |
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| Online Access: | https://doi.org/10.1186/s12883-023-03461-7 |
| _version_ | 1797452178841927680 |
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| author | Maria Tereza Mota Alvarenga Louise Ada Elisabeth Preston Lívia Cristina Guimarães Caetano Luci Fuscaldi Teixeira-Salmela Aline A Scianni |
| author_facet | Maria Tereza Mota Alvarenga Louise Ada Elisabeth Preston Lívia Cristina Guimarães Caetano Luci Fuscaldi Teixeira-Salmela Aline A Scianni |
| author_sort | Maria Tereza Mota Alvarenga |
| collection | DOAJ |
| description | Abstract 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. |
| first_indexed | 2024-03-09T15:05:02Z |
| format | Article |
| id | doaj.art-8696eaab250440ee94ad3c065d86e8a4 |
| institution | Directory Open Access Journal |
| issn | 1471-2377 |
| language | English |
| last_indexed | 2024-03-09T15:05:02Z |
| publishDate | 2023-11-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Neurology |
| spelling | doaj.art-8696eaab250440ee94ad3c065d86e8a42023-11-26T13:41:58ZengBMCBMC Neurology1471-23772023-11-012311910.1186/s12883-023-03461-7Home-based self-management for sedentary individuals with mild walking disability after stroke: protocol for a randomised pilot studyMaria Tereza Mota Alvarenga0Louise Ada1Elisabeth Preston2Lívia Cristina Guimarães Caetano3Luci Fuscaldi Teixeira-Salmela4Aline A Scianni5Department of Physiotherapy, Federal University of Minas GeraisFaculty of Medicine and Health, The University of SydneySchool of Rehabilitation and Exercise Science, University of CanberraDepartment of Physiotherapy, Federal University of Minas GeraisDepartment of Physiotherapy, Federal University of Minas GeraisDepartment of Physiotherapy, Federal University of Minas GeraisAbstract 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.https://doi.org/10.1186/s12883-023-03461-7StrokePhysical activitySelf-managementBehaviour change techniquesHome-based interventionPilot clinical trial |
| spellingShingle | Maria Tereza Mota Alvarenga Louise Ada Elisabeth Preston Lívia Cristina Guimarães Caetano Luci Fuscaldi Teixeira-Salmela Aline A Scianni Home-based self-management for sedentary individuals with mild walking disability after stroke: protocol for a randomised pilot study BMC Neurology Stroke Physical activity Self-management Behaviour change techniques Home-based intervention Pilot clinical trial |
| title | Home-based self-management for sedentary individuals with mild walking disability after stroke: protocol for a randomised pilot study |
| title_full | Home-based self-management for sedentary individuals with mild walking disability after stroke: protocol for a randomised pilot study |
| title_fullStr | Home-based self-management for sedentary individuals with mild walking disability after stroke: protocol for a randomised pilot study |
| title_full_unstemmed | Home-based self-management for sedentary individuals with mild walking disability after stroke: protocol for a randomised pilot study |
| title_short | Home-based self-management for sedentary individuals with mild walking disability after stroke: protocol for a randomised pilot study |
| title_sort | home based self management for sedentary individuals with mild walking disability after stroke protocol for a randomised pilot study |
| topic | Stroke Physical activity Self-management Behaviour change techniques Home-based intervention Pilot clinical trial |
| url | https://doi.org/10.1186/s12883-023-03461-7 |
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