Effect of a Multidimensional Intervention Programme on Post-stroke Fatigue
1 other identifier
interventional
90
1 country
1
Brief Summary
This study aims to evaluate the effects of a multidimensional intervention programme on fatigue and related outcomes among people with stroke.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Jun 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2025
CompletedFirst Submitted
Initial submission to the registry
June 11, 2025
CompletedFirst Posted
Study publicly available on registry
June 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
June 27, 2025
June 1, 2025
1 year
June 11, 2025
June 18, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Fatigue Assessment Scale
The scale scores range from 10-50, with higher score indicating higher level of fatigue.
baseline, end of week 4, end of week 8, and 3-month after the completion of the intervention
Secondary Outcomes (4)
Pittsburgh Sleep Quality Index
baseline, end of week 4, end of week 8, and 3-month after the completion of the intervention
Geriatric Depression Scale
baseline, end of week 4, end of week 8, and 3-month after the completion of the intervention
6-minute walk test
baseline, end of week 4, end of week 8, and 3-month after the completion of the intervention
Cardio-ankle vascular index
baseline, end of week 4, end of week 8, and 3-month after the completion of the intervention
Study Arms (3)
cognitive behavioural programme with physical training
EXPERIMENTALhealth education with physical training
ACTIVE COMPARATORUsual care
OTHERInterventions
Participants will receive 7 sessions of cognitive behavioural programme over 8 weeks and have physical training at home for 8 weeks.
Participants will receive 7 sessions of health education over 8 weeks and have physical training at home for 8 weeks.
Participants will maintain their usual life and activities for 8 weeks.
Eligibility Criteria
You may qualify if:
- diagnosed with stroke at least 6 months ago
- Fatigue Assessment Scale score ≥20
- cognitively intact
You may not qualify if:
- Unstable medical conditions
- with any other neurological diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Hong Kong Polytechnic University
Hong Kong, Hong Kong
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof
Study Record Dates
First Submitted
June 11, 2025
First Posted
June 27, 2025
Study Start
June 1, 2025
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
June 27, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share