StrokeENAbLE-SweNCT05111951
Mobile Health to Promote Physical Activity Post Stroke
A study testing Mobile health-delivered physical exercise and support for physical activity and Mobile health-delivered behavior change techniques. in people with Stroke and Transient Ischemic Attack, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Transient Ischemic Attack
- What is being tested?
- Mobile health-delivered physical exercise and support for physical activity and Mobile health-delivered behavior change techniques.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteSweden
- Study dates
- 1 Nov 2021to 22 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Sweden1 site
Division of Physiotherapy, Department of Neurobiology, Care Sciences and Society Karolinska Institutet
Stockholm, 14183
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Transient Ischemic Attack
- Being tested
- Mobile health-delivered physical exercise and support for physical activity, Mobile health-delivered behavior change techniques.
- Keywords
- Mobile health, Information and Communication Technology, Health promotion, Physical activity, Physical exercise, Secondary stroke prevention
- Medical subject headings
- Stroke, Ischemic Attack, Transient, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile health-delivered physical exercise and support for physical activityBehavioural
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.Behavioural
Mobile health-delivered behavior change techniques following the core elements of the Swedish model for physical activity on prescription.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Mobile health-delivered behavior change techniques. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Throughout the intervention period (0-6 months)
Sample representativeness
Contrasting the demographic details of study sample with national data.
Measured: Throughout the intervention period (0-6 months)
Compliance to the clinical trial
Number of participants who will not complete the trial.
Measured: Throughout the intervention period (0-6 months)
Compliance to the intervention protocol
Number of intervention sessions not completed and the reason for uncompleted sessions.
Measured: Throughout the intervention period (0-6 months)
Fidelity - exercise dose
Performed exercise dose (i.e. number of sessions).
Measured: 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).
Measured: Throughout the intervention period (0-6 months)
Fidelity - individual physical activity counseling
Performance of individual physical activity counseling.
Measured: Throughout the intervention period (0-6 months)
Fidelity - information on physical activity and health
Provision of information on physical activity and health.
Measured: Throughout the intervention period (0-6 months)
Fidelity - individual physical activity goals
Establishment of individual physical activity goals.
Measured: Throughout the intervention period (0-6 months)
Fidelity - structured follow-ups of goal fulfillment
Performance of structured follow-ups of goal fulfillment.
Measured: Throughout the intervention period (0-6 months)
Compliance to treatment protocols
Adherence to treatment schedules.
Measured: Throughout the intervention period (0-6 months)
Compliance to the assessment protocols
Adherence to assessment schedules.
Measured: 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.
Measured: Throughout the study period (0-12 months)
Secondary outcomes (11)
Systolic blood pressure
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).
Measured: 3 months, 6 months, and 12 months after baseline assessment
Physical activity - walking time
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)
Measured: 3 months, 6 months, and 12 months after baseline assessment
Physical activity - number of daily steps
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)
Measured: 3 months, 6 months, and 12 months after baseline assessment
Physical activity - standing time
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)
Measured: 3 months, 6 months, and 12 months after baseline assessment
Sedentary - sitting time
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)
Measured: 3 months, 6 months, and 12 months after baseline assessment
Walking abilities
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).
Measured: 3 months, 6 months, and 12 months after baseline assessment
Confidence performing daily activities
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).
Measured: 3 months, 6 months, and 12 months after baseline assessment
Self-efficacy for exercise
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).
Measured: 3 months, 6 months, and 12 months after baseline assessment
Fatigue
Fatigue Severity Scale
- 9 item scores summed to a total score with a possible range between 9 and 63 (higher score = greater fatigue severity).
Measured: 3 months, 6 months, and 12 months after baseline assessment
Depression, anxiety and stress
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).
Measured: 3 months, 6 months, and 12 months after baseline assessment
Health-related Quality of life
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).
Measured: 6 months, and 12 months after baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start1 Nov 2021
- Primary completion22 Dec 2023
- Study completion22 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Moulaee Conradsson, Karolinska Institutet
- Investigators
- David Moulaee Conradsson, PhD, Principal investigator, Division of Physiotherapy, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111951
- Sponsor's protocol ID
- Dnr 2020-05062
- Other IDs
- 2022-01403, 2021-01018
- Acronym
- ENAbLE-Swe
- Status last verified
- Dec 2023
- First submitted
- 28 Sep 2021
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33895733Thurston 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.
PubMed 36978045Thurston 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.
PubMed 39800974
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENAbLE-Sweden. Secondary Prevention of Stroke: Mobile Health to Promote Physical Activity in People Post Stroke or Transient Ischemic Attack
- ClinicalTrials.gov ID
- NCT05111951
- Acronym / sponsor ID
- ENAbLE-Swe / Dnr 2020-05062
- Conditions
- Stroke, Transient Ischemic Attack
- Keywords
- Mobile health, Information and Communication Technology, Health promotion, Physical activity, Physical exercise, Secondary stroke prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 22 Dec 2023 (actual)
- Study completion
- 22 Dec 2023 (actual)
- First posted
- 8 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile health-delivered physical exercise and physical activity | Experimental | Behavioral: Mobile health-delivered physical exercise and support for physical activity* 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. |
| Mobile health-delivered behavioural change techniques for physical activity | Active comparator | Behavioral: Mobile health-delivered behavior change techniques.* 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile health-delivered physical exercise and support for physical activityMobile health-delivered physical exercise sessions, prescription of an individual exercise-regime and support for physical activity through behavior change techniques. | Behavioural | Mobile health-delivered physical exercise and physical activity |
| Mobile health-delivered behavior change techniques.Mobile health-delivered behavior change techniques following the core elements of the Swedish model for physical activity on prescription. | Behavioural | Mobile health-delivered behavioural change techniques for physical activity |
Primary outcome
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.
Sample representativeness
Time frame: Throughout the intervention period (0-6 months)
Contrasting the demographic details of study sample with national data.
Compliance to the clinical trial
Time frame: Throughout the intervention period (0-6 months)
Number of participants who will not complete the trial.
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.
Fidelity - exercise dose
Time frame: Throughout the intervention period (0-6 months)
Performed exercise dose (i.e. number of sessions).
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).
Fidelity - individual physical activity counseling
Time frame: Throughout the intervention period (0-6 months)
Performance of individual physical activity counseling.
Fidelity - information on physical activity and health
Time frame: Throughout the intervention period (0-6 months)
Provision of information on physical activity and health.
Fidelity - individual physical activity goals
Time frame: Throughout the intervention period (0-6 months)
Establishment of individual physical activity goals.
Fidelity - structured follow-ups of goal fulfillment
Time frame: Throughout the intervention period (0-6 months)
Performance of structured follow-ups of goal fulfillment.
Compliance to treatment protocols
Time frame: Throughout the intervention period (0-6 months)
Adherence to treatment schedules.
Compliance to the assessment protocols
Time frame: Throughout the intervention period (0-6 months)
Adherence to assessment schedules.
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.
11 secondary outcomes
Systolic blood pressure
Time frame: 3 months, 6 months, and 12 months after baseline assessment
Physical activity - walking time
Time frame: 3 months, 6 months, and 12 months after baseline assessment
Physical activity - number of daily steps
Time frame: 3 months, 6 months, and 12 months after baseline assessment
Physical activity - standing time
Time frame: 3 months, 6 months, and 12 months after baseline assessment
Sedentary - sitting time
Time frame: 3 months, 6 months, and 12 months after baseline assessment
Walking abilities
Time frame: 3 months, 6 months, and 12 months after baseline assessment
Confidence performing daily activities
Time frame: 3 months, 6 months, and 12 months after baseline assessment
Self-efficacy for exercise
Time frame: 3 months, 6 months, and 12 months after baseline assessment
Fatigue
Time frame: 3 months, 6 months, and 12 months after baseline assessment
Depression, anxiety and stress
Time frame: 3 months, 6 months, and 12 months after baseline assessment
Health-related Quality of life
Time frame: 6 months, and 12 months after baseline assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Background: PubMed 33895733English 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.
- Background: PubMed 36978045Thurston 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.
- Derived from this study: PubMed 39800974Thurston 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.
- Individual participant dataSharing planned: No
Related trials for Stroke
Recruiting
Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
Stroke, Acute
RecruitingPhase 4
Xeomin® and Gait Related Mobility After Stroke
Stroke
RecruitingObservational study
Implementing Transcranial Direct Current Stimulation in a Rehabilitation Setting
Aphasia, Stroke
Not yet recruiting
EEG Feedback-Based Vagus Nerve Stimulation for Post-Stroke Dysphagia
Ischemic Stroke, Post-stroke Dysphagia
RecruitingObservational study
Development and Validation of Risk Prediction Models for Stroke and Cognitive Impairment in Moyamoya Disease and Moyamoya Syndrome
Moyamoya Disease, Moyamoya Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Moulaee Conradsson, PhD principal investigator
Division of Physiotherapy, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile health-delivered physical exercise and support for physical activity and Mobile health-delivered behavior change techniques. in people with Stroke and Transient Ischemic Attack, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Throughout the intervention period (0-6 months)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05111951, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2023.