Mobile Health to Promote Physical Activity Post Stroke

NCT05111951 | Completed

• 3 other identifiers: Dnr 2020-050622022-014032021-01018
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Transient Ischemic Attack

Keywords

Mobile health; Information and Communication Technology; Health promotion; Physical activity; Physical exercise; Secondary stroke prevention

Outcome Measures

Primary Outcomes (13)

• Recruitment rate

  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.

  Throughout the intervention period (0-6 months)

• Sample representativeness

  Contrasting the demographic details of study sample with national data.

  Throughout the intervention period (0-6 months)

• Compliance to the clinical trial

  Number of participants who will not complete the trial.

  Throughout the intervention period (0-6 months)

• Compliance to the intervention protocol

  Number of intervention sessions not completed and the reason for uncompleted sessions.

  Throughout the intervention period (0-6 months)

• Fidelity - exercise dose

  Performed exercise dose (i.e. number of sessions).

  Throughout the intervention period (0-6 months)

• Fidelity - physical intensity

  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

  Performance of individual physical activity counseling.

  Throughout the intervention period (0-6 months)

• Fidelity - information on physical activity and health

  Provision of information on physical activity and health.

  Throughout the intervention period (0-6 months)

• Fidelity - individual physical activity goals

  Establishment of individual physical activity goals.

  Throughout the intervention period (0-6 months)

• Fidelity - structured follow-ups of goal fulfillment

  Performance of structured follow-ups of goal fulfillment.

  Throughout the intervention period (0-6 months)

• Compliance to treatment protocols

  Adherence to treatment schedules.

  Throughout the intervention period (0-6 months)

• Compliance to the assessment protocols

  Adherence to assessment schedules.

  Throughout the intervention period (0-6 months)

• Adverse events

  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 Outcomes (11)

• Systolic blood pressure

  3 months, 6 months, and 12 months after baseline assessment

• Physical activity - walking time

  3 months, 6 months, and 12 months after baseline assessment

• Physical activity - number of daily steps

  3 months, 6 months, and 12 months after baseline assessment

• Physical activity - standing time

  3 months, 6 months, and 12 months after baseline assessment

• Sedentary - sitting time

  3 months, 6 months, and 12 months after baseline assessment

Study Arms (2)

Mobile health-delivered physical exercise and physical activity

EXPERIMENTAL

* 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.

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

Mobile health-delivered behavioural change techniques for physical activity

ACTIVE COMPARATOR

* 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.

Behavioral: Mobile health-delivered behavior change techniques.

Interventions

Mobile health-delivered physical exercise and support for physical activity BEHAVIORAL

Mobile health-delivered physical exercise sessions, prescription of an individual exercise-regime and support for physical activity through behavior change techniques.

Mobile health-delivered physical exercise and physical activity

Mobile health-delivered behavior change techniques. BEHAVIORAL

Mobile health-delivered behavior change techniques following the core elements of the Swedish model for physical activity on prescription.

Mobile health-delivered behavioural change techniques for physical activity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Division of Physiotherapy, Department of Neurobiology, Care Sciences and Society Karolinska Institutet

Stockholm, 14183, Sweden

Location

Related Publications (3)

• 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.

  PMID: 33895733 BACKGROUND

• 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.

  PMID: 36978045 BACKGROUND

• 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.

  PMID: 39800974 DERIVED

MeSH Terms

Conditions

Stroke; Ischemic Attack, Transient; Motor Activity

Interventions

Palliative Care; Exercise

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Behavior

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• David Moulaee Conradsson, PhD

  Division of Physiotherapy, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The researcher responsible for data management and analysis of the secondary outcomes will be blinded to group allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: November 8, 2021
• Study Start: November 1, 2021
• Primary Completion: December 22, 2023
• Study Completion: December 22, 2023
• Last Updated: December 29, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)