TreatmentNCT05573867
Digital Coaching With" Physical Activity on Prescription ( FaR) to Increase Physical Activity and Reduce Post Stroke Fatigue
A study testing Physical activity on prescription in people with Treatment, run by Region Gävleborg at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment
- What is being tested?
- Physical activity on prescription
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 12 Jun 2023to 12 Jun 2025
- 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
- Stroke 1 to 5 years ago
- Living in Gästrikland
- Post Stroke Fatigue ( S-FAS ≥ 24)
Who cannot join
- Severe stroke (Modified Rankin Scale >3)
- Depression ( Geriatric Depression Scale >5)
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Region Gävleborg
Gävle
Maria Svedjebrant, PhD, maria.svedjebrant@regiongavleborg.se
About this study
Official title: Individualized Digital Coaching Twice a Week for 12 Weeks With " Physical Activity on Prescription " (FaR) to Increase Physical Activity and Reduce Post Stroke Fatigue ( PSF)
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.
Read more
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.
Read the detailed description
Design: RCT with comparison between intervention and control group before and after 12 weeks of intervention and 6 months after completion
- Selection is made from the National Stroke Register ( Riksstroke) based on data at 3-month follow-up. Those who do not live in their own accommodation and people with a severe stroke (>3 according to the Modified Rankin Scale) are excluded.
- Persons who meet the inclusion criteria receive written information about the study, consent form and inclusion questions sent to their home address. The inclusion questions aim to ensure that the person has access to a computer/mobile phone with a camera and sound and does not participate in professionally led rehabilitation that includes physical training. Those who are interested send answers including written consent in the attached reply envelope to the researcher in charge.
- Two self-rating scales are sent home together with addressed and stamped response envelopes to screen for PSF and depression. The scales are the Swedish Fatigue Assessment Scale (S-FAS) and the Geriatric Depression Scale (GDS-15).
- Those who meet the inclusion criteria on the PSF (S-FAS ≥ 24) and are not judged to have depression (0-5 points on the GDS-15) proceed to the next step. Those judged to have depression are excluded and offered a referral to their health center written by the responsible physician.
- Blood test analysis is carried out to rule out other causes of fatigue. A referral is prescribed by a physician in the project group and sent via the strokeunit, the hospital in Gävle, to the person's home address. The blood sample is taken at the person's health center and then analyzed by physician in the project group.
- Persons who is not excluded are randomized (1:1, block size 2:4). Group affiliation is only revealed during the home visit that all included receive and after the assessment scales used as baseline measurement are completed.
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.
- Conditions
- Treatment
- Being tested
- Physical activity on prescription
- Keywords
- post stroke fatigue, digital coaching, physical activity, physical activity on prescription
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity on prescriptionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Physical activity on prescription |
| Control group | No intervention | Control group receive routine written and verbal information about PSF and information about recommended level of physical activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: Change between the 3 time points ( baseline, post and 6 months post intervention)
Secondary outcomes (3)
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.
Measured: Change between the 3 time points ( baseline, post and 6 months post intervention)
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.
Measured: 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
Measured: Change between the 3 time points ( baseline, post and 6 months post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start12 Jun 2023
- Primary completion12 Jun 2025 (estimated)
- Study completion12 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TreatmentStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Gävleborg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ylva Nilsagård, MD, Study chair, County of Örebro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573867
- Sponsor's protocol ID
- 279072
- Status last verified
- Feb 2024
- First submitted
- 27 Sep 2022
- Last updated
- 23 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Digital Coaching Twice a Week for 12 Weeks With " Physical Activity on Prescription " (FaR) to Increase Physical Activity and Reduce Post Stroke Fatigue ( PSF)
- ClinicalTrials.gov ID
- NCT05573867
- Acronym / sponsor ID
- 279072
- Conditions
- Treatment
- Keywords
- post stroke fatigue, digital coaching, physical activity, physical activity on prescription
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Region GävleborgUniversity, hospital or other
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 12 Jun 2025 (estimated)
- Study completion
- 12 Jun 2025 (estimated)
- First posted
- 10 Oct 2022 (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.
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.
Detailed description
Design: RCT with comparison between intervention and control group before and after 12 weeks of intervention and 6 months after completion
- Selection is made from the National Stroke Register ( Riksstroke) based on data at 3-month follow-up. Those who do not live in their own accommodation and people with a severe stroke (>3 according to the Modified Rankin Scale) are excluded.
- Persons who meet the inclusion criteria receive written information about the study, consent form and inclusion questions sent to their home address. The inclusion questions aim to ensure that the person has access to a computer/mobile phone with a camera and sound and does not participate in professionally led rehabilitation that includes physical training. Those who are interested send answers including written consent in the attached reply envelope to the researcher in charge.
- Two self-rating scales are sent home together with addressed and stamped response envelopes to screen for PSF and depression. The scales are the Swedish Fatigue Assessment Scale (S-FAS) and the Geriatric Depression Scale (GDS-15).
- Those who meet the inclusion criteria on the PSF (S-FAS ≥ 24) and are not judged to have depression (0-5 points on the GDS-15) proceed to the next step. Those judged to have depression are excluded and offered a referral to their health center written by the responsible physician.
- Blood test analysis is carried out to rule out other causes of fatigue. A referral is prescribed by a physician in the project group and sent via the strokeunit, the hospital in Gävle, to the person's home address. The blood sample is taken at the person's health center and then analyzed by physician in the project group.
- Persons who is not excluded are randomized (1:1, block size 2:4). Group affiliation is only revealed during the home visit that all included receive and after the assessment scales used as baseline measurement are completed.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Physical activity on prescriptionIndividualized, 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stroke 1 to 5 years ago
- Living in Gästrikland
- Post Stroke Fatigue ( S-FAS ≥ 24)
Key exclusion criteria (2 listed)
- Severe stroke (Modified Rankin Scale >3)
- Depression ( Geriatric Depression Scale >5)
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 |
|---|---|---|
| Physical activity on prescriptionAll 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. | Other | Intervention group |
Primary outcome
Swedish Fatigue Assessment Scale ( S-FAS)
Time frame: Change between the 3 time points ( baseline, post and 6 months post intervention)
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.
ActivPaL
Time frame: Change between the 3 time points ( baseline, post and 6 months post intervention)
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)
3 secondary outcomes
GIH stationary single-item question ( SED-GIH) and activity level.
Time frame: Change between the 3 time points ( baseline, post and 6 months post intervention)
Activities-specific Balance Confidence scale ( ABC)
Time frame: Change between the 3 time points ( baseline, post and 6 months post intervention)
Exercise self-efficacy scale
Time frame: Change between the 3 time points ( baseline, post and 6 months post intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
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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.
Ylva Nilsagård, MD study chair
County of Örebro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity on prescription in people with Treatment, run by Region Gävleborg 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 23 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Svedjebrant, PhD (+46722282142, maria.svedjebrant@regiongavleborg.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Swedish Fatigue Assessment Scale ( S-FAS) (time frame: Change between the 3 time points ( baseline, post and 6 months post intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2024.