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Completed

NCT Number: NCT05111951

Mobile Health to Promote Physical Activity Post Stroke

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Stockholm, 14183, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 behavior change techniques.

Behavioral

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

Primary outcomes

  1. 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.

  2. Sample representativeness

    Time frame: Throughout the intervention period (0-6 months)

    Contrasting the demographic details of study sample with national data.

  3. Compliance to the clinical trial

    Time frame: Throughout the intervention period (0-6 months)

    Number of participants who will not complete the trial.

  4. 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.

  5. Fidelity - exercise dose

    Time frame: Throughout the intervention period (0-6 months)

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

  6. 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).

  7. Fidelity - individual physical activity counseling

    Time frame: Throughout the intervention period (0-6 months)

    Performance of individual physical activity counseling.

  8. Fidelity - information on physical activity and health

    Time frame: Throughout the intervention period (0-6 months)

    Provision of information on physical activity and health.

  9. Fidelity - individual physical activity goals

    Time frame: Throughout the intervention period (0-6 months)

    Establishment of individual physical activity goals.

  10. Fidelity - structured follow-ups of goal fulfillment

    Time frame: Throughout the intervention period (0-6 months)

    Performance of structured follow-ups of goal fulfillment.

  11. Compliance to treatment protocols

    Time frame: Throughout the intervention period (0-6 months)

    Adherence to treatment schedules.

  12. Compliance to the assessment protocols

    Time frame: Throughout the intervention period (0-6 months)

    Adherence to assessment schedules.

  13. Adverse events

    Time frame: Throughout the study period (0-12 months)

    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.

Secondary outcomes

  1. Systolic blood pressure

    Time frame: 3 months, 6 months, and 12 months after baseline assessment

    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).

  2. Physical activity - walking time

    Time frame: 3 months, 6 months, and 12 months after baseline assessment

    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)

  3. Physical activity - number of daily steps

    Time frame: 3 months, 6 months, and 12 months after baseline assessment

    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)

  4. 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)

  5. 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)

  6. Walking abilities

    Time frame: 3 months, 6 months, and 12 months after baseline assessment

    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).
  7. 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).
  8. 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).
  9. 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).
  10. 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).
  11. Health-related Quality of life

    Time frame: 6 months, and 12 months after baseline assessment

    EuroQuol-5 Dimensions (EQ5D)

    EQ5D comprises:

    • 5-items survey (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), resulting in a 5-digit summary index which describes the patient's health state.
    • Assessment of the person's self-rated health on a vertical visual analogue scale (VAS), where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS scale (ranging between 0 to 100, higher value = better self-rated health).

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

ENAbLE-Sweden. Secondary Prevention of Stroke: Mobile Health to Promote Physical Activity in People Post Stroke or Transient Ischemic Attack

Acronym: ENAbLE-Swe

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 8, 2021
Registry last updated
Dec 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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