Physical Exercise as Treatment Post-stroke Fatigue - a Feasibilty Study.

NCT ID: NCT07206147

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2026-06-01

Brief 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. 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

1. Legs - leg press, squat or raise.

2. Arms - biceps curls (dumbbells or rubber bands).

3. Legs - Knee extension with load (gym machine, weight cuff, rubber band, cable station).

4. Shoulder - lat pull down (gym machine, rubber band).

5. Core - sit-ups or other core training.

6. Shoulder - rowing (cable station, rubber bands, dumbbells).

7. Balance - stand on one leg, tandem standing.

8. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FaStEx

Group Type: EXPERIMENTAL

FaStEx - Structured strength training

Intervention Type: 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.

Control group

Group Type: ACTIVE_COMPARATOR

Control group

Intervention Type: OTHER

150 minutes of physical activity per week that is carried out independently.

Interventions

FaStEx - Structured strength training

Strength training in group session, 2 times a week for 8 weeks. 150 minutes of physical activity per week that is carried out independently.

Intervention Type: OTHER

Control group

150 minutes of physical activity per week that is carried out independently.

Intervention Type: OTHER

Eligibility Criteria

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

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Örebro University, Sweden

OTHER

Sponsor Role: collaborator

Strokeförbundet

UNKNOWN

Sponsor Role: collaborator

Hjärnskadefonden

UNKNOWN

Sponsor Role: collaborator

Region Örebro County

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Region Örebro county

Örebro, , Sweden

Countries

Sweden

Central Contacts

Sofia Kangedal, MSc

Role: CONTACT

sofia.kangedal@regionorebrolan.se

+46196029119

Gustav Jarl, Associate professor

Role: CONTACT

Other Identifiers

282165

Identifier Type: -

Identifier Source: org_study_id