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| Name | Class |
|---|---|
| Örebro University, Sweden | OTHER |
| Strokeförbundet | UNKNOWN |
| Hjärnskadefonden | UNKNOWN |
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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:
Researchers will compare FaStEx to physical activity at home to see if FaStEx can reduce post-stroke fatigue.
Participants will
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FaStEx | Experimental |
| |
| Control group | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FaStEx - Structured strength training | Other | Strength training in group session, 2 times a week for 8 weeks. 150 minutes of physical activity per week that is carried out independently. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline. End of treament at 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Chair stand test. | Change in leg strength. Records the number of stands a person can complete in 30 seconds. | Baseline. End of treament at 8 weeks. |
| Activities-specific Balance Confidence Scale |
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Inclusion Criteria:
- Stroke ≥6 months, able to move independently ≥100 meters with or without a walking aid, speak Swedish, Fatigue assessment scale (FAS) ≥24 points
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sofia Kangedal, MSc | Contact | +46196029119 | sofia.kangedal@regionorebrolan.se | |
| Gustav Jarl, Associate professor | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Region Örebro county | Örebro | 70116 | Sweden |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D005221 | Fatigue |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Control group | Other | 150 minutes of physical activity per week that is carried out independently. |
|
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.
| 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. | 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. | 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. | 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. | 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. | 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. | Measurement will take place continuously from baseline to end of treatment at 8 weeks |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D008722 | Methods |