Mobile Health to Promote Physical Activity Post Stroke (ENAbLE-Swe)

Karolinska Institute

Status: Completed

Conditions: Stroke; Transient Ischemic Attack

Treatments: Behavioral: Mobile health-delivered physical exercise and support for physical activity; Behavioral: Mobile health-delivered behavior change techniques.

Study type: Interventional

Funder types: Other

Identifiers

NCT05111951

2022-01403 (Other Grant/Funding Number)

2021-01018 (Other Grant/Funding Number)

Dnr 2020-05062

Details and patient eligibility

About

Support for physical activity is necessary to sustain health and reduce the risk of stroke recurrence after stroke or transient ischemic attack (TIA). Still, rehabilitation services are not available to many of those who potentially would benefit from such services largely due to barriers related to accessibility. While mobile health is a promising strategy to support physical activity, there is a gap in knowledge regarding the implementation of technology that meet the needs of people post stroke or TIA in order to foster adherence and engagement in physical activity. This project therefore seeks to improve health and reduce the risk of recurrent stroke among people post stroke or TIA by increasing the access to physical activity through telehealth.

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.

Full description

In order to make the i-REBOUND program accessible to people post stroke or TIA across Sweden, a mobile application was developed in a co-design process with people post stroke or TIA, physiotherapists and stakeholders. The application enables monitoring and management of exercise (supervised online and prescribed exercise), communication through video calls and chat, self-monitoring of exercise compliance and physical activity, and scheduled digital surveys on function and health. The application will be used in this study to deliver the experimental and control intervention, but also for remote assessments of function and health (e.g. digital questionnaires).

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.

Enrollment: 116 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged over 18 years
• 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

• Medical conditions limiting the ability to exercise (e.g. unstable cardiac conditions or severe arthritis)
• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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116 participants in 2 patient groups

Mobile health-delivered physical exercise and physical activity

Experimental group

Description:

* 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.

Treatment:

Behavioral: Mobile health-delivered physical exercise and support for physical activity

Mobile health-delivered behavioural change techniques for physical activity

Active Comparator group

Description:

* 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.

Treatment:

Behavioral: Mobile health-delivered behavior change techniques.