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Not yet recruiting NCT07041138

Effect of a Multidimensional Intervention Programme on Post-stroke Fatigue

No phase Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: cognitive behavioural programme with physical training, health education with physical training, Usual Care.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: 50 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Interventions

  • Behavioral cognitive 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.
  • Behavioral health education with physical training
    Participants will receive 7 sessions of health education over 8 weeks and have physical training at home for 8 weeks.
  • Behavioral Usual Care
    Participants will maintain their usual life and activities for 8 weeks.

Primary outcome measures

  • Fatigue Assessment Scale [Time frame: baseline, end of week 4, end of week 8, and 3-month after the completion of the intervention]
Secondary outcome measures (4)
  • Pittsburgh Sleep Quality Index [Time frame: baseline, end of week 4, end of week 8, and 3-month after the completion of the intervention]
  • Geriatric Depression Scale [Time frame: baseline, end of week 4, end of week 8, and 3-month after the completion of the intervention]
  • 6-minute walk test [Time frame: baseline, end of week 4, end of week 8, and 3-month after the completion of the intervention]
  • Cardio-ankle vascular index [Time frame: baseline, end of week 4, end of week 8, and 3-month after the completion of the intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • The Hong Kong Polytechnic University — Hong Kong

Identifiers

NCT: NCT07041138 · CBTPT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗