ClinicalTrials.gg
RecruitingNCT05573867Updated Feb 23, 2024

Digital Coaching With" Physical Activity on Prescription ( FaR) to Increase Physical Activity and Reduce Post Stroke Fatigue

An interventional study of Physical activity on prescription in Treatment, sponsored by Region Gävleborg. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-23.

Sponsored by Region Gävleborg · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 5 months ago, but the record still lists the study as recruiting.
  • Started Jun 2023; still recruiting 3 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 193 studies in Motor Activity with a site in Sweden — 43 open to participants now, 57 under way, none of them phase 3. Motor Activity · Sweden.

Planned enrollment
141st of 160
20 · median 98
Started
2023
with 12 others
No phase
148 of 193
35 open now
Primary completion
2025-06
later than 8 of 56 live
Registered
135th of 193
by date

Among the 193 studies in Motor Activity with a site in Sweden, this one is the 141st largest by planned enrollment of the 160 interventional ones, is one of 13 that started in 2023, is one of 148 with no phase, reaches primary completion later than 8 of the 56 other live ones, and was the 135th registered.

By phase

193 studies; the count open now beside each. This study's row is marked.

No phasethis study148 · 35 open
Observational33 · 7 open
Phase 26 · 1 open
Phase 13 · 0 open
Phase 32 · 0 open
Phase 41 · 0 open

By the year they started

First in 2002; this study’s year is marked. 13 started in 2023.

Size and results

Median enrollment 98 across the 160 interventional studies, 141 across the 33 observational. Of the 112 that completed or were terminated, 8 (7%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 193 studies in Motor Activity with a site in Sweden, or all of them as a file.
02

Study 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. 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.

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

  1. 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.
  2. 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.
  3. 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).
  4. 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.
  5. 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.
  6. 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.

03

Conditions studied

  • Treatment

Browse trials for

Keywords

  • post stroke fatigue
  • digital coaching
  • physical activity
  • physical activity on prescription
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Stroke 1 to 5 years ago
  • Living in Gästrikland
  • Post Stroke Fatigue ( S-FAS ≥ 24)

Exclusion criteria

Exclusion Criteria:

  • Severe stroke (Modified Rankin Scale >3)
  • Depression ( Geriatric Depression Scale >5)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Intervention group

    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: Physical activity on prescription

  • No intervention
    Control group

    Control group receive routine written and verbal information about PSF and information about recommended level of physical activity.

Interventions

  • OtherPhysical activity on prescription

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Change between the 3 time points ( baseline, post and 6 months post intervention)

  2. 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)

    Time frame: Change between the 3 time points ( baseline, post and 6 months post intervention)

Secondary outcomes

  1. 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.

    Time frame: Change between the 3 time points ( baseline, post and 6 months post intervention)

  2. 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.

    Time frame: Change between the 3 time points ( baseline, post and 6 months post intervention)

  3. Exercise self-efficacy scale

    Exercise self-efficacy scale is a self administrated questionnaire to assess one's own ability to cope with physical activity

    Time frame: Change between the 3 time points ( baseline, post and 6 months post intervention)

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2023 (actual). Primary completion is estimated for Jun 2025, 24 months after the start.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 24 months is above that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 27, 2022
First posted
Oct 10, 2022
StartActual
Jun 12, 2023
Primary completionEst.
Jun 12, 2025
CompletionEst.
Jun 12, 2025
Last update
Feb 23, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05573867
Lead sponsor
Region Gävleborg
Responsible party
Sponsor
First posted
Oct 10, 2022
Start date
Jun 12, 2023
Primary completion
Jun 12, 2025 (estimated)
Completion
Jun 12, 2025 (estimated)
Last update
Feb 23, 2024

Study contacts

Maria Svedjebrant, PhD
Contact
maria.svedjebrant@regiongavleborg.se
+46722282142
Ylva Nilsagård, MD
Contact
ylva.nilsagard@regionorebrolan.se
+46706093737
Ylva Nilsagård, MD
study chair · County of Örebro

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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