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Effect of a Multidimensional Intervention Programme on Post-stroke Fatigue

Effect of a Multidimensional Intervention Programme on Post-stroke Fatigue

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07041138
Enrollment
90
Registered
2025-06-27
Start date
2025-06-30
Completion date
2026-06-30
Last updated
2025-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Brief summary

This study aims to evaluate the effects of a multidimensional intervention programme on fatigue and related outcomes among people with stroke.

Interventions

BEHAVIORALcognitive behavioural programme with physical training

Participants will receive 7 sessions of cognitive behavioural programme over 8 weeks and have physical training at home for 8 weeks.

BEHAVIORALhealth education with physical training

Participants will receive 7 sessions of health education over 8 weeks and have physical training at home for 8 weeks.

BEHAVIORALUsual Care

Participants will maintain their usual life and activities for 8 weeks.

Sponsors

The Hong Kong Polytechnic University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* diagnosed with stroke at least 6 months ago * Fatigue Assessment Scale score ≥20 * cognitively intact

Exclusion criteria

* Unstable medical conditions * with any other neurological diseases

Design outcomes

Primary

MeasureTime frameDescription
Fatigue Assessment Scalebaseline, end of week 4, end of week 8, and 3-month after the completion of the interventionThe scale scores range from 10-50, with higher score indicating higher level of fatigue.

Secondary

MeasureTime frameDescription
Pittsburgh Sleep Quality Indexbaseline, end of week 4, end of week 8, and 3-month after the completion of the interventionThe scale scores range from 0-21, with higher score indicating poorer sleep quality.
Geriatric Depression Scalebaseline, end of week 4, end of week 8, and 3-month after the completion of the interventionThe scale scores range from 0-15, with higher score indicating worse depressive symptoms.
6-minute walk testbaseline, end of week 4, end of week 8, and 3-month after the completion of the intervention
Cardio-ankle vascular indexbaseline, end of week 4, end of week 8, and 3-month after the completion of the intervention

Countries

Hong Kong

Contacts

Primary ContactShamay NG
shamay.ng@polyu.edu.hk852-2766-4889

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026