Promoting Physical Activity After Stroke Via Self-management

Study Overview
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Brief Summary
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Practising physical activity after a stroke is essential for the secondary prevention of stroke. However, the major individuals after stroke are sedentary. Individuals after stroke with mild disabilities could have fewer barriers to this practice. Thus, finding ways to promote physical activity after stroke in these individuals is important for them and public health. Interventions that consider behaviour change strategies are a good way to change a habit and could improve physical activity levels. Self-management interventions have been used to promote behaviour change in the stroke population. The aim of this pilot trial will be to determine the efficacy of a self-management program to increase physical activity levels in stroke survivors with mild disability through 6 home-based sessions of self-management exercise over 3 and 6 months in a low-income country. Our secondary aims are to evaluate the effect of a self-management program on walking, exercise self-efficacy, participation, quality of life, depression and cardiovascular risks after 3 and 6 months.

Detailed Description
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One-quarter of stroke events in the world are recurrent. Stroke secondary prevention is essential for this population and health politics. The practice of a physical activity is a good option to reduce the chance to develop a second stroke. Self-management interventions have been used in the stroke population to increase physical activity. However, a review showed that the efficacy of this intervention to improve physical activity is inconclusive. Recently, a study of feasibility made in Brazil about the self-management approach showed positive results in this intervention to increase physical activity after stroke survivors with mild impairment. In addition, the results can be more beneficial for sedentary individuals. The aim of this study will be to test the efficacy of a home-based self-management exercise intervention to improve physical activity levels in sedentary individuals with a mild disability after stroke. The specific questions are: In sedentary individuals with a mild disability after stroke, Is a home-based self-management exercise effective in improving physical activity effective at increasing the number of steps taken per day? Does any improvement in physical activity carry over to improvements in cardiovascular risk, walking ability, depressive symptoms, exercise self-efficacy, social participation and quality of life?

Official Title
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A Randomized, Controlled Pilot Study of a Home-based Self-management Exercise Program for Sedentary Individuals With Mild Disability After Stroke

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: Home-based self-management exercise program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: time since stroke less than 6 months; ≥18 years of age; be able to walk 10 meters independently at a speed ≥ 0.8 m/s without any walk devices; had no cognitive impairments (determined by the cut-off scores on the Brazilian version of the Mini-Mental State Examination); be sedentary (steps counts less than 5000 steps/day). Exclusion Criteria: have other neurological diseases (e.g. Parkinson, Multiple Sclerosis); had comprehensive aphasia (evaluated by simple motor command: lift your good arm and raise your hand); have any other conditions that would prevent participation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home-based self-management exercise program<br>A home-based self-management exercise program will be implemented based on behaviour change techniques on the approach of Social-Cognitive Theory and Control Theory. In the present study, we will use the following behaviour changes techniques: health consequences, action planning, graded tasks, problem-solving/coping planning, modelling of the behaviour, vicarious reinforcement and non-specific encouragement, feedback on behaviour, self-monitoring on behaviour, review behaviour goals and goal setting (behaviour). The program will include six sessions of self-management with an average duration of 60 minutes. The intervention will be delivered individually and face-to-face in the participant's home by a physical therapist over 10 weeks. | Behavioral: Home-based self-management exercise program<br>* Session 1 will includes education about stroke. Session 2 will includes feedback on behaviour performance on initial measurement outcomes, health consequences of the physical inactivity, answering an exercise preferences questionnaire, generation of a list of goals, delivering a smartband and a diary to self-monitoring. Session 3 will includes reviewing of goals and strategies to self-monitoring, encouragement, rising barriers to exercise and potential solutions to them, development of a weekly schedule physical exercise, implementation of the physical exercise session with participant and delivering a paper-exercise guide. Session 4 will includes reviewing of goals and weekly schedule physical exercise, encouragement, problem solving/coping planning, reviewing strategies to self-monitoring and showing to participant a video with another stroke survivors which are physically active. Sessions 5 and 6 will be the same as session 4 with exception of vicarious reinforcement.<br>|
| No Intervention: Control Group<br>This group will receive one session about education on risk factors after stroke and usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline physical activity level at 3 months and 6 months | We will measure the level of physical activity through steps taken per day using the Actigraph wGT3X-BT. The participants will be informed to use the device during the waking hours, except during water activities. | 3 months, and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index | body mass index (BMI) (weight and height will be combined to report BMI in kg/m^2) | 3 months, and 6 months | 
| Waist circumference | waist circumference (centimeters) | 3 months, and 6 months | 
| Blood pressure | systolic and diastolic blood pressure (millimeters of mercury) | 3 months, and 6 months | 
| Depression | Will be measured with the short version of the Geriatric Depression Scale. The results will be expressed in scores of 0-15. The 0 is the worse score. | 3 months, and 6 months | 
| Walking capacity | Will be measured through the distance covered in the 6-Minute Walk Test. | 3 months, and 6 months | 
| Walking speed | Will be measured through the comfortable and maximum walking speed, with the 10- Meter Walk Test. | 3 months, and 6 months | 
| Self-Efficacy for exercise | Will be measured through the Self-Efficacy for Exercise. The results will be expressed in scores of 0-10. The 0 is the worse score. | 3 months, and 6 months | 
| Social participation | Will be measured through the participation domain of the Stroke Impact Scale. The results will be expressed in percentage 0-100%. Higher percentage demonstrate better social participation levels. | 3 months, and 6 months | 
| Perception of quality of life | Will be measured through EuroQual-5D. The results will be expressed in scores of 0-100. The 0 is the worse score. | 3 months, and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, self-management, physical activity