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Stroke is the leading cause in the world considering disabilities and approximately half of the patient population experience post stroke fatigue (PSF). PSF affects the patients level of activity and their quality of life. Even patients with mild stroke claim that PSF is one of the main reasons hindering them from being physically active.
People suffering from stroke generally have lower physical capacity compared to healthy individuals of the same age and they are spending more time in sedentary. Physical inactivity is considered to be one of the main modifiable risk factors for stroke. There is strong evidence that physical activity will improve health and reduce the risk of future strokes.
Evaluation of interventions to reduce PSF is a prioritized research field since it is currently lacking evidence. There is a possibility that physical training can have a positive effect on PSF.
Digital alternatives to on-site visits will increase the availability and can strengthen the patients independence which is according to the government and Sveriges Kommuner och Regioner ( SKR) common vision for e-health.
The aim of this study is to evaluate the feasibility of individualized, digital coaching twice a week for 12 weeks with "Physical activity on prescription" (FaR) to increase physical activity and reduce PSF after stroke.
Design: RCT with comparison between intervention and control group before and after 12 weeks of intervention and 6 months after completion
All participants, regardless of group affiliation, receive a home visit when routine written and oral information about PSF and information about the recommended level of physical activity according to national guidelines is given Those who have been randomized to the intervention group receive "Physical activity on prescription" (FaR) as a supplement. FaR is a prescription based on Physical Activity in the Prevention and Treatment of Disease ( FYSS in Swedish) and consists of three main parts: individual counseling, individually tailored written prescription (intensity, duration and frequency) and individually tailored follow-up. The advisory conversation is based on Motivational Interviewing (MI) and is based on the person's needs and motivation for change, as well as the person's knowledge of physical activity related to their condition. After the conversation, they agree on the type of physical activity and dose (intensity, duration and frequency). Based on the conversation, the person receives "Physical activity on prescription" (FaR) a written, individually adapted prescription. Digital coaching then takes place based on the individual's FaR twice a week for 12 weeks. FaR is given by PhD student in the project who is a registered physiotherapist and has extensive clinical experience in stroke rehabilitation as well as training in the method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Individualized, digital coaching twice a week for 12 weeks with "Physical activity on prescription" (FaR) to increase physical activity and reduce PSF after stroke. |
|
| Control group | No Intervention | Control group receive routine written and verbal information about PSF and information about recommended level of physical activity. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical activity on prescription | Other | All participants, regardless of group affiliation, receive routine written and verbal information about PSF and information about recommended level of physical activity. Intervention group receive as add on individualized, digital coaching twice a week for 12 weeks with "Physical activity on prescription" (FaR) to increase physical activity and reduce PSF after stroke. |
| Measure | Description | Time Frame |
|---|---|---|
| Swedish Fatigue Assessment Scale ( S-FAS) | The S-FAS is a self administrated questionnaire to assess fatigue. The total scores ranges from 10 to 50. A total S-FAS score ≥24 indicates fatigue. | Change between the 3 time points ( baseline, post and 6 months post intervention) |
| ActivPaL | The ActivPaL activity monitor is a small device worn on the thigh that uses information about static and dynamic acceleration to 1) distinguish body posture as sitting/lying, standing and stepping and 2) estimate energy expenditure (EE) (expressed as metabolic equivalents (METs) | Change between the 3 time points ( baseline, post and 6 months post intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| GIH stationary single-item question ( SED-GIH) and activity level. | For assessment of activity level, the National Board of Health and Welfare's indicator questions for physical activity are used, which is a self-assessment scale of time spent on physical training and everyday exercise. Self-assessment in sedentary behavior (SED-GIH), is used for assesment of sedentary behavior. | Change between the 3 time points ( baseline, post and 6 months post intervention) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Svedjebrant, PhD | Contact | +46722282142 | maria.svedjebrant@regiongavleborg.se | |
| Ylva Nilsagård, MD | Contact | +46706093737 | ylva.nilsagard@regionorebrolan.se |
| Name | Affiliation | Role |
|---|---|---|
| Ylva Nilsagård, MD | County of Örebro | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Region Gävleborg | Recruiting | Gävle | Sweden |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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|
| Activities-specific Balance Confidence scale ( ABC) | The Activities-specific Balance Confidence Scale (ABC Scale) is a structured questionnaire that measures an individual's confidence in performing activities without losing balance. The activities are rated on a 0-100% scale where a high percentage means full confidence and low percentage implies no confidence. | Change between the 3 time points ( baseline, post and 6 months post intervention) |
| Exercise self-efficacy scale | Exercise self-efficacy scale is a self administrated questionnaire to assess one's own ability to cope with physical activity | Change between the 3 time points ( baseline, post and 6 months post intervention) |