ACTRN12619000626167Completed未知
Reducing fatigue after stroke: A randomised controlled trial
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Enrollment
- 200
Study Overview
Brief Summary
Results are not yet available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to o limit (—)
- Sex
- All
Inclusion Criteria
- •To be eligible to take part in the study, potential participants must meet the following criteria:
- •(a) CT/MRI confirmed stroke to enable exclusion of stroke-mimic conditions;
- •(b) clinically significant fatigue at 3 to 24-months after stroke;
- •(c) residing in the study areas (Auckland, Waikato) to ensure feasibility;
- •(d) ability to converse in English to support understanding of group discussions and materials; and
- •(e) able to provide informed consent.
Exclusion Criteria
- •Pre-stroke fatigue, given differing aetiology requiring a different intervention approach; significant cognitive (MMSE <23 or Montreal Cognitive Assessment <26) or behavioural impairments (e.g. agitation, major depressive criteria measured by the CES-D revised - depression scale); significant disability (mRS 4-5) due to high dependence for basic Acitivities of Daily Living making some Fatigue Severity Scale (FSS) items not applicable (i.e. ‘my fatigue prevents sustained physical functioning) making it difficult to accurately detect changes in fatigue; identified causes of chronic fatigue (e.g. sleep apnea); medical instability, or other health condition (e.g. dementia, drug/alcohol abuse) that would preclude full participation; and participation in another clinical trial.
Investigators
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