- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05111951
Mobile Health to Promote Physical Activity Post Stroke (ENAbLE-Swe)
ENAbLE-Sweden. Secondary Prevention of Stroke: Mobile Health to Promote Physical Activity in People Post Stroke or Transient Ischemic Attack
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.
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Stockholm, Sweden, 14183
- Division of Physiotherapy, Department of Neurobiology, Care Sciences and Society Karolinska Institutet
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mobile health-delivered physical exercise and physical activity
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Mobile health-delivered physical exercise sessions, prescription of an individual exercise-regime and support for physical activity through behavior change techniques.
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Active Comparator: Mobile health-delivered behavioural change techniques for physical activity
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Mobile health-delivered behavior change techniques following the core elements of the Swedish model for physical activity on prescription.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recruitment rate
Time Frame: Throughout the intervention period (0-6 months)
|
The proportion of participants screened who will be deemed eligible for the trial and the proportion of those consented who will be randomized to the trial.
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Throughout the intervention period (0-6 months)
|
Sample representativeness
Time Frame: Throughout the intervention period (0-6 months)
|
Contrasting the demographic details of study sample with national data.
|
Throughout the intervention period (0-6 months)
|
Compliance to the clinical trial
Time Frame: Throughout the intervention period (0-6 months)
|
Number of participants who will not complete the trial.
|
Throughout the intervention period (0-6 months)
|
Compliance to the intervention protocol
Time Frame: Throughout the intervention period (0-6 months)
|
Number of intervention sessions not completed and the reason for uncompleted sessions.
|
Throughout the intervention period (0-6 months)
|
Fidelity - exercise dose
Time Frame: Throughout the intervention period (0-6 months)
|
Performed exercise dose (i.e.
number of sessions).
|
Throughout the intervention period (0-6 months)
|
Fidelity - physical intensity
Time Frame: Throughout the intervention period (0-6 months)
|
Performed exercise intensity assessed using the Borg Rating of Perceived Exertion Scale.
The Borg Rating of Perceived Exertion Scale assess perceived exertion based on a 6 to 20 rating scale (higher score = higher perceived exertion).
|
Throughout the intervention period (0-6 months)
|
Fidelity - individual physical activity counseling
Time Frame: Throughout the intervention period (0-6 months)
|
Performance of individual physical activity counseling.
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Throughout the intervention period (0-6 months)
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Fidelity - information on physical activity and health
Time Frame: Throughout the intervention period (0-6 months)
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Provision of information on physical activity and health.
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Throughout the intervention period (0-6 months)
|
Fidelity - individual physical activity goals
Time Frame: Throughout the intervention period (0-6 months)
|
Establishment of individual physical activity goals.
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Throughout the intervention period (0-6 months)
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Fidelity - structured follow-ups of goal fulfillment
Time Frame: Throughout the intervention period (0-6 months)
|
Performance of structured follow-ups of goal fulfillment.
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Throughout the intervention period (0-6 months)
|
Compliance to treatment protocols
Time Frame: Throughout the intervention period (0-6 months)
|
Adherence to treatment schedules.
|
Throughout the intervention period (0-6 months)
|
Compliance to the assessment protocols
Time Frame: Throughout the intervention period (0-6 months)
|
Adherence to assessment schedules.
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Throughout the intervention period (0-6 months)
|
Adverse events
Time Frame: Throughout the study period (0-12 months)
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Adverse events may include falls, injuries, gastrointestinal issues requiring medical review or cardiac events.
Trial therapists will record any adverse events that occur during telehealth sessions, and participants will answer a study specific questionnaire at the commencement of each exercise session, and at each assessment to self-report any adverse events that occur at other times during the study.
|
Throughout the study period (0-12 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Systolic blood pressure
Time Frame: 3 months, 6 months, and 12 months after baseline assessment
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Systolic blood pressure measured with a portable blood pressure monitor (Omron M7 Intelli IT-AFIB), to be measured 3 times in the morning and afternoon for 7 days consecutively (minimum 3 days or 6 measures required to be used in the project evaluation).
|
3 months, 6 months, and 12 months after baseline assessment
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Physical activity - walking time
Time Frame: 3 months, 6 months, and 12 months after baseline assessment
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Walking time (minutes) per day as measured by the ActivPal accelerometer to be worn continuously for 7 consecutive days (minimum of 3 days data required to be used in the evaluation)
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3 months, 6 months, and 12 months after baseline assessment
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Physical activity - number of daily steps
Time Frame: 3 months, 6 months, and 12 months after baseline assessment
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Number of daily steps as measured by the ActivPal accelerometer to be worn continuously for 7 consecutive days (minimum of 3 days data required to be used in the evaluation)
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3 months, 6 months, and 12 months after baseline assessment
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Physical activity - standing time
Time Frame: 3 months, 6 months, and 12 months after baseline assessment
|
Standing time (minutes) per day as measured by the ActivPal accelerometer to be worn continuously for 7 consecutive days (minimum of 3 days data required to be used in the evaluation)
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3 months, 6 months, and 12 months after baseline assessment
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Sedentary - sitting time
Time Frame: 3 months, 6 months, and 12 months after baseline assessment
|
Sitting time (minutes) per day as measured by the ActivPal accelerometer to be worn continuously for 7 consecutive days (minimum of 3 days data required to be used in the evaluation)
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3 months, 6 months, and 12 months after baseline assessment
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Walking abilities
Time Frame: 3 months, 6 months, and 12 months after baseline assessment
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Generic Walk-12 Scale: - 12 item scores summed to a total score with a possible range between 0 and 42 (higher score = more walking difficulties). |
3 months, 6 months, and 12 months after baseline assessment
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Confidence performing daily activities
Time Frame: 3 months, 6 months, and 12 months after baseline assessment
|
Activities-Specific Balance Confidence scale - 16 item scores averaged to a mean score with a possible range between 0 to 100 (higher score = higher balance confidence). |
3 months, 6 months, and 12 months after baseline assessment
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Self-efficacy for exercise
Time Frame: 3 months, 6 months, and 12 months after baseline assessment
|
Exercise Self-Efficacy Scale - 9 item scores averaged to a mean score with a possible range between 0 to 100 (higher score = highly confident to exercise). |
3 months, 6 months, and 12 months after baseline assessment
|
Fatigue
Time Frame: 3 months, 6 months, and 12 months after baseline assessment
|
Fatigue Severity Scale - 9 item scores summed to a total score with a possible range between 9 and 63 (higher score = greater fatigue severity). |
3 months, 6 months, and 12 months after baseline assessment
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Depression, anxiety and stress
Time Frame: 3 months, 6 months, and 12 months after baseline assessment
|
Depression Anxiety Stress Scale (DASS-21) - DASS-21 contains 21 questions divided in 3 subscales (depression, anxiety and stress) with 7 items on each scale. Each sub-scale is summed into a total score with a possible range between 0 and 24 (higher score = higher levels of symptoms related to depression/anxiety/stress). |
3 months, 6 months, and 12 months after baseline assessment
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Health-related Quality of life
Time Frame: 6 months, and 12 months after baseline assessment
|
EuroQuol-5 Dimensions (EQ5D) EQ5D comprises:
|
6 months, and 12 months after baseline assessment
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David Moulaee Conradsson, PhD, Division of Physiotherapy, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dnr 2020-05062
- 2022-01403 (Other Grant/Funding Number: Swedish Research Council)
- 2021-01018 (Other Grant/Funding Number: The Swedish Research Council for Health, Working Life and Welfare)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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