NCT07206147

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable stroke

Timeline
1mo left

Started Jan 2026

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Jan 2026Jun 2026

First Submitted

Initial submission to the registry

July 25, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 3, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

October 3, 2025

Status Verified

September 1, 2025

Enrollment Period

5 months

First QC Date

July 25, 2025

Last Update Submit

September 25, 2025

Conditions

StrokeFatigue Symptom

Keywords

Post-stroke fatigueStrokePhysical exercisePhysical activityPhysiotherapy

Outcome Measures

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.

    Baseline. End of treament at 8 weeks.

Secondary Outcomes (8)

  • Chair stand test.

    Baseline. End of treament at 8 weeks.

  • Activities-specific Balance Confidence Scale

    Baseline. End of treament at 8 weeks.

  • Patient health questionnaire

    Baseline. End of treament at 8 weeks.

  • 6 minute walking test

    Baseline. End of treament at 8 weeks.

  • RAND 36

    Baseline. End of treament at 8 weeks.

  • +3 more secondary outcomes

Study Arms (2)

FaStEx

EXPERIMENTAL
Other: FaStEx - Structured strength training

Control group

ACTIVE COMPARATOR
Other: Control group

Interventions

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.

FaStEx
Control groupOTHER

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

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Stroke ≥6 months, able to move independently ≥100 meters with or without a walking aid, speak Swedish, Fatigue assessment scale (FAS) ≥24 points

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Region Örebro county

Örebro, 70116, Sweden

Location

MeSH Terms

Conditions

StrokeFatigueMotor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

Sofia Kangedal, MSc

CONTACT

+46196029119sofia.kangedal@regionorebrolan.se

Gustav Jarl, Associate professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2025

First Posted

October 3, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

October 3, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)