Effect of High-Intensity Interval Training Intervention on Post-Stroke Fatigue in Chronic Stroke Survivors: A Pilot Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Eligibility rate (%)
Study Overview
Brief Summary
This study aims to investigate the effect of high-intensity interval training (HIIT) on fatigue severity among individuals with chronic stroke. Participants will be randomly assigned to the HIIT group, the moderate-intensity continuous training (MICT) group, or the stretching group (active control). Each group will participate in supervised exercise sessions three times per week over a 12-week period, totaling 36 sessions. Outcome assessments will be conducted at baseline, mid-intervention (week 6), post-intervention (week 12), and follow-up (week 20). The primary outcome will be fatigue severity. Secondary outcomes will include inflammatory biomarkers and additional health-related indicators.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age of 40-80 years;
- •a history of ischemic stroke resulting in unilateral limb impairment 6-60 months prior to consent to participate in the pilot trial;
- •a stable medical condition;
- •a subjective feeling of fatigue, defined as a period of apparent fatigue, decreased energy, increased need for rest, or fatigue out of proportion to physical activity for at least 2 weeks during the past month;
- •ability to communicate with the investigators and lack of significant cognitive deficits;
- •able to walk for 10 meters with or without a walking aid.
Exclusion Criteria
- •An FSS score of < 4 (20);
- •other neurological conditions;
- •other musculoskeletal comorbidities that would prevent safe participation in exercises;
- •a medical diagnosis of significant cardiovascular, pulmonary, or metabolic disease(s);
- •signs or symptoms indicative of significant cardiovascular, pulmonary, or metabolic disease(s) during the previous 3 months;
- •severe lower limb spasticity (Ashworth Scale score ≥ 3);
- •Botulinum toxin use in the affected lower limb within the past six months;
- •current or previous use of drugs intended to resolve post-stroke fatigue;
- •active engagement in other stroke rehabilitation trials.
Outcomes
Primary Outcomes
Eligibility rate (%)
Time Frame: Through study completion, an average of 12 weeks.
Compliance with HIIT (%)
Time Frame: From baseline to week 12
Recruitment rate (number of participants per month)
Time Frame: Through study completion, an average of 12 weeks.
Fidelity to the HIIT protocol (%)
Time Frame: From baseline to week 12
Adverse events (number of events)
Time Frame: From baseline to week 12
Retention of the intervention (%)
Time Frame: From baseline to week 12
Acceptability (qualitative)
Time Frame: At week 12
Secondary Outcomes
- Multidimensional Fatigue Inventory (MDI)(Blinded assessors will conduct evaluations at baseline, week 12 , and week 20.)
- Short Form-36 Health Survey (SF-36)(Blinded assessors will conduct evaluations at baseline, week 6, and week 12.)
- Fatigue Severity Scale (FSS)(Blinded assessors will conduct evaluations at baseline, week 12 , and week 20.)
- Inflammatory biomarkers(Blinded assessors will conduct evaluations at baseline, week 6, and week 12.)
Investigators
Dr HUANG Mei Zhen
Assistant professor
The Hong Kong Polytechnic University