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NCT Number: NCT07041138

Effect of a Multidimensional Intervention Programme on Post-stroke Fatigue

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

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cognitive behavioural programme with physical training

Behavioral

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

health education with physical training

Behavioral

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

Usual Care

Behavioral

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

Primary outcomes

  1. Fatigue Assessment Scale

    Time frame: baseline, end of week 4, end of week 8, and 3-month after the completion of the intervention

    The scale scores range from 10-50, with higher score indicating higher level of fatigue.

Secondary outcomes

  1. Pittsburgh Sleep Quality Index

    Time frame: baseline, end of week 4, end of week 8, and 3-month after the completion of the intervention

    The scale scores range from 0-21, with higher score indicating poorer sleep quality.

  2. Geriatric Depression Scale

    Time frame: baseline, end of week 4, end of week 8, and 3-month after the completion of the intervention

    The scale scores range from 0-15, with higher score indicating worse depressive symptoms.

  3. 6-minute walk test

    Time frame: baseline, end of week 4, end of week 8, and 3-month after the completion of the intervention

  4. Cardio-ankle vascular index

    Time frame: baseline, end of week 4, end of week 8, and 3-month after the completion of the intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Shamay NG

CONTACT

[email protected]

852-2766-4889

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 27, 2025
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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