Clinical trial NCT05111951: Mobile Health to Promote Physical Activity Post Stroke
Official title: ENAbLE-Sweden. Secondary Prevention of Stroke: Mobile Health to Promote Physical Activity in People Post Stroke or Transient Ischemic Attack
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Transient Ischemic Attack
Keywords: Mobile health
Information and Communication Technology
Health promotion
Physical activity
Physical exercise
Secondary stroke prevention
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recruitment rate
timeFrame: Throughout the intervention period (0-6 months)
measure: Sample representativeness
timeFrame: Throughout the intervention period (0-6 months)
measure: Compliance to the clinical trial
timeFrame: Throughout the intervention period (0-6 months)
measure: Compliance to the intervention protocol
timeFrame: Throughout the intervention period (0-6 months)
measure: Fidelity - exercise dose
timeFrame: Throughout the intervention period (0-6 months)
measure: Fidelity - physical intensity
timeFrame: Throughout the intervention period (0-6 months)
measure: Fidelity - individual physical activity counseling
timeFrame: Throughout the intervention period (0-6 months)
measure: Fidelity - information on physical activity and health
timeFrame: Throughout the intervention period (0-6 months)
measure: Fidelity - individual physical activity goals
timeFrame: Throughout the intervention period (0-6 months)
measure: Fidelity - structured follow-ups of goal fulfillment
timeFrame: Throughout the intervention period (0-6 months)
measure: Compliance to treatment protocols
timeFrame: Throughout the intervention period (0-6 months)
measure: Compliance to the assessment protocols
timeFrame: Throughout the intervention period (0-6 months)
measure: Adverse events
timeFrame: Throughout the study period (0-12 months)
Secondary outcomes:
measure: Systolic blood pressure
timeFrame: 3 months, 6 months, and 12 months after baseline assessment
measure: Physical activity - walking time
timeFrame: 3 months, 6 months, and 12 months after baseline assessment
measure: Physical activity - number of daily steps
timeFrame: 3 months, 6 months, and 12 months after baseline assessment
measure: Physical activity - standing time
timeFrame: 3 months, 6 months, and 12 months after baseline assessment
measure: Sedentary - sitting time
timeFrame: 3 months, 6 months, and 12 months after baseline assessment
measure: Walking abilities
timeFrame: 3 months, 6 months, and 12 months after baseline assessment
measure: Confidence performing daily activities
timeFrame: 3 months, 6 months, and 12 months after baseline assessment
measure: Self-efficacy for exercise
timeFrame: 3 months, 6 months, and 12 months after baseline assessment
measure: Fatigue
timeFrame: 3 months, 6 months, and 12 months after baseline assessment
measure: Depression, anxiety and stress
timeFrame: 3 months, 6 months, and 12 months after baseline assessment
measure: Health-related Quality of life
timeFrame: 6 months, and 12 months after baseline assessment
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Division of Physiotherapy, Department of Neurobiology, Care Sciences and Society Karolinska Institutet
Study officials:
affiliation: Division of Physiotherapy, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet
name: David Moulaee Conradsson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.