Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
116 participants
INTERVENTIONAL
2021-11-01
2023-12-22
Brief Summary
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The present project builds on experiences of telehealth-delivered physical activity in Australia where restricted access to health-care services is a longstanding problem. Collaborating researchers in Australia have developed a telehealth program (i-REBOUND- Let's get moving) which has been designed and tested in collaboration with end users, through a series of feasibility and pilot studies. The i-REBOUND program provides support for physical activity through physical exercises supervised by a physiotherapist and behavior change techniques for physical activity (i.e. individual counseling, information, recommendations, goal-setting, self-monitoring and structured follow-ups) across 6 months. The intervention is delivered to people post stroke or TIA in their own homes via video-meeting.
This study, which is conducted in Sweden, aims to evaluate if the i-REBOUND program supported by a new mobile application could be delivered as intended through a pilot randomized controlled trial in order to determine the feasibility and preliminary effects in people post stroke or TIA living in urban and rural regions of Sweden.
Detailed Description
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Study participants will be randomized to 1) an experimental group (n=60) receiving the mobile health version of the i-REBOUND program or 2) a control group (n=60) receiving behavioural change techniques for physical activity. The randomization schedule; 1:1, will be blocked and stratified by mobility status (independent/mobility device users) and geographical region (urban/rural areas).
Recruitment: Participants will be recruited through a national network of clinical sites across Sweden, social media and patient organizations.
Screening: Potential participants will be contacted via phone and verbal consent will be sought to provide further information. During this phone conversation, trial eligibility will be assessed according to the inclusion/exclusion criteria using a standardized checklist, including questions regarding cognitive functioning and the individual's usage of mobile applications.
Sample size: The anticipated sample size of 60 participants per group (total 120) builds on the ambition to test the feasibility of the i-REBOUND program among people post stroke/TIA with variation in disability, age and sex, and geographical location within Sweden (i.e. cities and rural areas).
Analysis: Outcomes of feasibility and safety (see primary outcomes) will primarily be analyzed using descriptive statistics in order to explore if the digital version of the i-REBOUND program could be delivered as intended. Preliminary effects of the intervention (see secondary outcomes) will be analyzed using a mixed-model analysis (or equivalent non-parametric statistics if the data is not normally distributed) to target differences in changes between the groups (experimental vs control) and time (baseline, and the 3, 6 and 12-months follow-up) on clinical outcomes.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Mobile health-delivered physical exercise and physical activity
* Duration: 6 months
* Supervised online exercise sessions (30-45 min/session) performed as individual or as group sessions. Exercises are tailored to individual needs in physical fitness and target at least moderate exercise intensity to obtain positive effects on cardiovascular health. Targeted dose: 2 sessions/week during months 1-3 and 1 session/week months 4-6.
* Prescription of an individual exercise-regime through the mobile-application (dose is determined based on participants needs).
* Application of behavior change techniques for physical activity. Two person-centered interviews with a physiotherapist seeking to assess motivation, exercise preferences and barriers to physical activity, and to identify 1-2 individual physical activity goals. The goals are followed-up and revised if needed months 1-6. Educational videos regarding physical activity and health are prescribed.
Mobile health-delivered physical exercise and support for physical activity
Mobile health-delivered physical exercise sessions, prescription of an individual exercise-regime and support for physical activity through behavior change techniques.
Mobile health-delivered behavioural change techniques for physical activity
* Duration: 6 months
* Remote service and contact with physiotherapists (video and chat) through a mobile application designed for this study.
* Behavioural change techniques for physical activity including general advice about physical activity, goal-setting, information and two follow-ups across the intervention period.
Mobile health-delivered behavior change techniques.
Mobile health-delivered behavior change techniques following the core elements of the Swedish model for physical activity on prescription.
Interventions
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Mobile health-delivered physical exercise and support for physical activity
Mobile health-delivered physical exercise sessions, prescription of an individual exercise-regime and support for physical activity through behavior change techniques.
Mobile health-delivered behavior change techniques.
Mobile health-delivered behavior change techniques following the core elements of the Swedish model for physical activity on prescription.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with stroke/TIA between 3 months to 10 years prior to study enrollment
* Living at home
* Have sufficient cognitive ability and/or support from family member in order to engage in the interventions
* Being able to walk short distances indoors
* Ability to use a smartphone/tablet including access to stable internet connection.
Exclusion Criteria
* Severe neglect and aphasia compromising the ability to follow instructions
* Meeting the recommended physical activity levels of at least 150 min per week of moderate physical activity or at least 75 min per week of vigorous intensity physical activity
* Enrolled in another physical activity trial.
18 Years
ALL
No
Sponsors
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Karolinska Institutet
OTHER
Responsible Party
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David Moulaee Conradsson
Associate professor
Principal Investigators
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David Moulaee Conradsson, PhD
Role: PRINCIPAL_INVESTIGATOR
Division of Physiotherapy, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet
Locations
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Division of Physiotherapy, Department of Neurobiology, Care Sciences and Society Karolinska Institutet
Stockholm, , Sweden
Countries
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References
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English C, Attia JR, Bernhardt J, Bonevski B, Burke M, Galloway M, Hankey GJ, Janssen H, Kuys S, Lindley RI, Lynch E, Marsden DL, Nilsson M, Ramage ER, Said CM, Spratt NJ, Zacharia K, Macdonald-Wicks L, Patterson A. Secondary Prevention of Stroke: Study Protocol for a Telehealth-Delivered Physical Activity and Diet Pilot Randomized Trial (ENAbLE-Pilot). Cerebrovasc Dis. 2021;50(5):605-611. doi: 10.1159/000515689. Epub 2021 Apr 23.
Thurston C, Bezuidenhout L, Humphries S, Johansson S, von Koch L, Hager CK, Holmlund L, Sundberg CJ, Garcia-Ptacek S, Kwak L, Nilsson M, English C, Conradsson DM. Mobile health to promote physical activity in people post stroke or transient ischemic attack - study protocol for a feasibility randomised controlled trial. BMC Neurol. 2023 Mar 28;23(1):124. doi: 10.1186/s12883-023-03163-0.
Thurston C, Humphries S, Bezuidenhout L, Johansson S, Holmlund L, von Koch L, English C, Moulaee Conradsson D. Mobile health delivered physical activity after mild stroke or transient ischemic attack: Is it feasible and acceptable? Int J Stroke. 2025 Aug;20(7):801-811. doi: 10.1177/17474930251315628. Epub 2025 Jan 30.
Other Identifiers
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2022-01403
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2021-01018
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
Dnr 2020-05062
Identifier Type: -
Identifier Source: org_study_id