StrokeNCT07206147
Physical Exercise as Treatment Post-stroke Fatigue - a Feasibilty Study.
A study testing FaStEx - Structured strength training in people with Stroke and Fatigue Symptom, run by Region Örebro County at 1 site in Sweden.
Trial summary
The goal of this clinical trial is to evaluate the feasibility the treatment FaStEx (FatigueStrokeExercise) which consists of strength exercise in people with brain fatigue after stroke, referred to as post-stroke fatigue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Fatigue Symptom
- What is being tested?
- FaStEx - Structured strength training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2026to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 ≥6 months, able to move independently ≥100 meters with or without a walking aid, speak Swedish, Fatigue assessment scale (FAS) ≥24 points
Who cannot join
- Other neurological disease. Severe impairment of vision, hearing and/or cognition that prevents participation in the intervention. Already performs structured strength training (e.g. gym, group training) regularly (at least 1 time/week).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Gustav Jarl, Associate professor contact
About this study
The goal of this clinical trial is to evaluate the feasibility the treatment FaStEx (FatigueStrokeExercise) which consists of strength exercise in people with brain fatigue after stroke, referred to as post-stroke fatigue. The main questions it aims to answer are:
- What is the feasibility of a study with the treatment FaStEx, structured physical training, for people with post-stroke fatigue?
- What factors are important for people with post-stroke fatigue to be able to complete the FaStEx treatment?
- How do people with post-stroke fatigue experience participation in the study with the FaStEx treatment?
Read more
Researchers will compare FaStEx to physical activity at home to see if FaStEx can reduce post-stroke fatigue.
Participants will
- Carry out strength training twice a week at a health care center.
- Carry out physical activity for at least 150 minutes per week on their own. Participants in the control group will carry out this physical activity as well.
- The treatment lasts for eight weeks.
Read the detailed description
Type of treatment FaStEx (FatigueStrokeExercise) - Structured physiotherapist-led exercise intervention.
Dose Strength training for 45 minutes, twice a week for eight weeks.
Components of exercises All training sessions will have the same structure and consist of warm-up, strength training and cool-down.
Each training session starts with a 10-minute warm-up on an exercise bike or through body movements. The strength training is performed as station training with one participant/station. The stations consist of eight different exercises. The participant performs 12 repetitions, 3 sets/exercise, 30 seconds rest between each set. Then rest and transfer to the next station, about 1 min. The load should be 10-12 RM and as a load are used body weight, dumbbells, gym machines, rubber bands, weight cuffs or kettlebells.
Exercises
- Legs - leg press, squat or raise.
- Arms - biceps curls (dumbbells or rubber bands).
- Legs - Knee extension with load (gym machine, weight cuff, rubber band, cable station).
- Shoulder - lat pull down (gym machine, rubber band).
- Core - sit-ups or other core training.
- Shoulder - rowing (cable station, rubber bands, dumbbells).
- Balance - stand on one leg, tandem standing.
- Legs - step-up board.
The training session ends with a cool-down through body movements and stretching.
Estimation of exertion with Borg RPE and brain fatigue with VAS before and after the session.
Place The training sessions are carried out in a training room at a health center.
Modifications Alternative exercises will be suggested by the instructor if necessary, e.g. the need for other equipment or support during the exercise. Participants are encouraged to perform the exercises to the best of their ability.
Choice of instructor The instructors are licensed physiotherapists who work in primary care in Region Örebro County who are used to instructing and individualizing training.
Home training In addition to the structured physiotherapist-led training, all participants in the study (control and intervention group) should independently perform aerobic physical activity of at least 150 min/v at a moderate intensity (Borg RPE 12-13). In connection with the start of the intervention, the participants receive an advisory conversation about physical activity to support how they can achieve 150 min/week.
Adherence Participation in strength training will be noted by the treating physiotherapist. Adherence to achieving physical activity for 150 min/w will be followed by participants filling out an activity diary.
- Conditions
- Stroke, Fatigue Symptom
- Being tested
- FaStEx - Structured strength training, Control group
- Keywords
- Post-stroke fatigue, Stroke, Physical exercise, Physical activity, Physiotherapy
- Medical subject headings
- Stroke, Fatigue, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FaStEx - Structured strength trainingOther
Strength training in group session, 2 times a week for 8 weeks. 150 minutes of physical activity per week that is carried out independently.
Control groupOther
150 minutes of physical activity per week that is carried out independently.
| Study group | Role | What they receive |
|---|---|---|
| FaStEx | Experimental | Not described Receives: Other: FaStEx - Structured strength training |
| Control group | Active comparator | Not described Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue assessment scale
Change in fatigue. 10-item Numerical Self-Rating Scale. Each item of the FAS is answered using a five-point, Likert-type scale ranging from 1 ("never") to 5 ("always"). Items 4 and 10 are reverse-scored. Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest.
Measured: Baseline. End of treament at 8 weeks.
Secondary outcomes (8)
Chair stand test.
Change in leg strength. Records the number of stands a person can complete in 30 seconds.
Measured: Baseline. End of treament at 8 weeks.
Activities-specific Balance Confidence Scale
Change in confidence in one's balance ability. 16-item Numerical Self-Rating Scale. Each item is answered using a scale ranging from 0 % ("No confidence") to 100 % ("Completely confident"). Total scores can range from 0, indicating the lowest level of confidence, to 100 , denoting the highest.
Measured: Baseline. End of treament at 8 weeks.
Patient health questionnaire
Change in depression. 9-item Numerical Self-Rating Scale. Each item is answered using a three-point, Likert-type scale ranging from "0" (not at all) to "3" (nearly every day). Total scores can range from 0, indicating no depression, to 27, denoting severe depression.
Measured: Baseline. End of treament at 8 weeks.
6 minute walking test
Change in aerobic capacity and walking ability. The test subject walks back and forth over a measured distance of 30 m at a self-selected speed. The test measures pulse, blood pressure, self-estimated exertion and distance walked.
Measured: Baseline. End of treament at 8 weeks.
RAND 36
Change in quality of life. 36-item Numerical Self-Rating Scale with multiple choice options. Total scores can range from 0, indicating worse quality of life, to 100, denoting better quality of life.
Measured: Baseline. End of treament at 8 weeks.
Levels of physical activity
Measured with accelerometer. The accelerometer is a small device worn on the thigh that measures movement in three planes.
Measured: Measurement will take place 1 week before baseline and 1 week after the intervention at 8 weeks.
Sedentary time
Measured with accelerometer. The accelerometer is a small device worn on the thigh that measures movement in three planes.
Measured: Measurement will take place 1 week before baseline and 1 week after the intervention at 8 weeks.
Levels of physical activity (self-reported)
Assessed with activity diary. The participants make notes of their physical activity during the treatment period.
Measured: Measurement will take place continuously from baseline to end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Collaborators
- Örebro University, Sweden, Strokeförbundet, Hjärnskadefonden
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07206147
- Sponsor's protocol ID
- 282165
- Status last verified
- Sep 2025
- First submitted
- 25 Jul 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Exercise as Treatment Post-stroke Fatigue - a Feasibilty Study.
- ClinicalTrials.gov ID
- NCT07206147
- Acronym / sponsor ID
- 282165
- Conditions
- Stroke, Fatigue Symptom
- Keywords
- Post-stroke fatigue, Stroke, Physical exercise, Physical activity, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Collaborators
- Örebro University, Sweden, Strokeförbundet, Hjärnskadefonden
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 3 Oct 2025 (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.
The goal of this clinical trial is to evaluate the feasibility the treatment FaStEx (FatigueStrokeExercise) which consists of strength exercise in people with brain fatigue after stroke, referred to as post-stroke fatigue. The main questions it aims to answer are:
- What is the feasibility of a study with the treatment FaStEx, structured physical training, for people with post-stroke fatigue?
- What factors are important for people with post-stroke fatigue to be able to complete the FaStEx treatment?
- How do people with post-stroke fatigue experience participation in the study with the FaStEx treatment?
Researchers will compare FaStEx to physical activity at home to see if FaStEx can reduce post-stroke fatigue.
Participants will
- Carry out strength training twice a week at a health care center.
- Carry out physical activity for at least 150 minutes per week on their own. Participants in the control group will carry out this physical activity as well.
- The treatment lasts for eight weeks.
Detailed description
Type of treatment FaStEx (FatigueStrokeExercise) - Structured physiotherapist-led exercise intervention.
Dose Strength training for 45 minutes, twice a week for eight weeks.
Components of exercises All training sessions will have the same structure and consist of warm-up, strength training and cool-down.
Each training session starts with a 10-minute warm-up on an exercise bike or through body movements. The strength training is performed as station training with one participant/station. The stations consist of eight different exercises. The participant performs 12 repetitions, 3 sets/exercise, 30 seconds rest between each set. Then rest and transfer to the next station, about 1 min. The load should be 10-12 RM and as a load are used body weight, dumbbells, gym machines, rubber bands, weight cuffs or kettlebells.
Exercises
- Legs - leg press, squat or raise.
- Arms - biceps curls (dumbbells or rubber bands).
- Legs - Knee extension with load (gym machine, weight cuff, rubber band, cable station).
- Shoulder - lat pull down (gym machine, rubber band).
- Core - sit-ups or other core training.
- Shoulder - rowing (cable station, rubber bands, dumbbells).
- Balance - stand on one leg, tandem standing.
- Legs - step-up board.
The training session ends with a cool-down through body movements and stretching.
Estimation of exertion with Borg RPE and brain fatigue with VAS before and after the session.
Place The training sessions are carried out in a training room at a health center.
Modifications Alternative exercises will be suggested by the instructor if necessary, e.g. the need for other equipment or support during the exercise. Participants are encouraged to perform the exercises to the best of their ability.
Choice of instructor The instructors are licensed physiotherapists who work in primary care in Region Örebro County who are used to instructing and individualizing training.
Home training In addition to the structured physiotherapist-led training, all participants in the study (control and intervention group) should independently perform aerobic physical activity of at least 150 min/v at a moderate intensity (Borg RPE 12-13). In connection with the start of the intervention, the participants receive an advisory conversation about physical activity to support how they can achieve 150 min/week.
Adherence Participation in strength training will be noted by the treating physiotherapist. Adherence to achieving physical activity for 150 min/w will be followed by participants filling out an activity diary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FaStEx | Experimental | Other: FaStEx - Structured strength training |
| Control group | Active comparator | Other: Control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Stroke ≥6 months, able to move independently ≥100 meters with or without a walking aid, speak Swedish, Fatigue assessment scale (FAS) ≥24 points
Key exclusion criteria (1 listed)
- Other neurological disease. Severe impairment of vision, hearing and/or cognition that prevents participation in the intervention. Already performs structured strength training (e.g. gym, group training) regularly (at least 1 time/week).
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 |
|---|---|---|
| FaStEx - Structured strength trainingStrength training in group session, 2 times a week for 8 weeks. 150 minutes of physical activity per week that is carried out independently. | Other | FaStEx |
| Control group150 minutes of physical activity per week that is carried out independently. | Other | Control group |
Primary outcome
Fatigue assessment scale
Time frame: Baseline. End of treament at 8 weeks.
Change in fatigue. 10-item Numerical Self-Rating Scale. Each item of the FAS is answered using a five-point, Likert-type scale ranging from 1 ("never") to 5 ("always"). Items 4 and 10 are reverse-scored. Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest.
8 secondary outcomes
Chair stand test.
Time frame: Baseline. End of treament at 8 weeks.
Activities-specific Balance Confidence Scale
Time frame: Baseline. End of treament at 8 weeks.
Patient health questionnaire
Time frame: Baseline. End of treament at 8 weeks.
6 minute walking test
Time frame: Baseline. End of treament at 8 weeks.
RAND 36
Time frame: Baseline. End of treament at 8 weeks.
Levels of physical activity
Time frame: Measurement will take place 1 week before baseline and 1 week after the intervention at 8 weeks.
Sedentary time
Time frame: Measurement will take place 1 week before baseline and 1 week after the intervention at 8 weeks.
Levels of physical activity (self-reported)
Time frame: Measurement will take place continuously from baseline to end of treatment at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: No
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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.
Gustav Jarl, Associate professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FaStEx - Structured strength training in people with Stroke and Fatigue Symptom, run by Region Örebro County 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 3 Oct 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sofia Kangedal, MSc (+46196029119, sofia.kangedal@regionorebrolan.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue assessment scale (time frame: Baseline. End of treament at 8 weeks.). 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 3 Oct 2025.