Physical Exercise as Treatment Post-stroke Fatigue - a Feasibilty Study.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Örebro County
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
FaStEx - Structured strength training
Other interventionStrength training in group session, 2 times a week for 8 weeks. 150 minutes of physical activity per week that is carried out independently.
Control group
Other intervention150 minutes of physical activity per week that is carried out independently.
Treatment groups
16 Participants
are divided into 2 treatment groupsGroup A: FaStExExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline. End of treament at 8 weeks.Secondary outcomes
1
Chair stand test.
Change in leg strength. Records the number of stands a person can complete in 30 seconds.
Time frame
Baseline. End of treament at 8 weeks.2
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.
Time frame
Baseline. End of treament at 8 weeks.3
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.
Time frame
Baseline. End of treament at 8 weeks.4
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.
Time frame
Baseline. End of treament at 8 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Region Örebro County
Lead sponsor
Örebro University, Sweden
Collaborator
Strokeförbundet
Collaborator
Hjärnskadefonden
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: