An interventional study of HIIT and MICT in Stroke, sponsored by The Hong Kong Polytechnic University. Recruiting at 1 site in Hong Kong. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-12-09.
Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Treatment
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →The Hong Kong Polytechnic University is the lead sponsor of 659 studies on the registry; 250 are open to participants now.
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Exclusion criteria:
Behavioral: HIIT
Behavioral: MICT
Behavioral: stretching
The HIIT intervention will consist of a 3-minute warm-up, a 25-minute main exercise, and a 2-minute cool-down. The main exercise will include four 4-minute high-intensity intervals, each interspersed with a 3-minute low-intensity recovery period. Participants will attend three supervised sessions per week over a 12-week period.
The MICT intervention will include a 3-minute warm-up, 25 minutes of continuous exercise performed at a moderate intensity, and a 2-minute cool-down. Participants will attend three supervised sessions per week over a 12-week period.
The stretching intervention will consist of 30 minutes of whole-body stretching. Participants will attend three sessions per week over a 12-week period.
Eligibility rate (%)
Time frame: Through study completion, an average of 12 weeks.
Recruitment rate (number of participants per month)
Time frame: Through study completion, an average of 12 weeks.
Compliance with HIIT (%)
Time frame: From baseline to week 12
Fidelity to the HIIT protocol (%)
Time frame: From baseline to week 12
Retention of the intervention (%)
Time frame: From baseline to week 12
Adverse events (number of events)
Time frame: From baseline to week 12
Acceptability (qualitative)
Time frame: At week 12
Fatigue Severity Scale (FSS)
The FSS consists of 9 items rated on a 7-point Likert scale from 1 (highly disagree) to 7 (highly agree). Higher scores indicate greater fatigue severity.
Time frame: Blinded assessors will conduct evaluations at baseline, week 12 , and week 20.
Multidimensional Fatigue Inventory (MDI)
The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report questionnaire designed to assess fatigue across five dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation, and Reduced Activity. Each subscale contains 4 items rated on a 5-point Likert scale. Higher scores indicate greater fatigue. The total score ranges from 20 to 100.
Time frame: Blinded assessors will conduct evaluations at baseline, week 12 , and week 20.
Short Form-36 Health Survey (SF-36)
The SF-36 includes 36 items and one additional item assessing perceived change in health over time. Each domain is scored on a scale from 0 to 100, with higher scores indicating better health status.
Time frame: Blinded assessors will conduct evaluations at baseline, week 6, and week 12.
Inflammatory biomarkers
Inflammatory biomarkers will be quantified using enzyme-linked immunosorbent assay (ELISA) kits obtained from commercial suppliers, following the manufacturer's instructions.
Time frame: Blinded assessors will conduct evaluations at baseline, week 6, and week 12.
Hospital Anxiety and Depression Scale (HADS)
The HADS consists of 14 items, divided into two subscales: anxiety (HADS-A) and depression (HADS-D), each containing 7 items. Each item is scored on a 4-point Likert scale (0-3), resulting in subscale scores ranging from 0 to 21. Higher scores indicate greater severity of anxiety or depression.
Time frame: Blinded assessors will conduct evaluations at baseline, week 12 , and week 20.
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is consists of 19 items grouped into seven components. Each component is scored from 0 to 3, yielding a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality.
Time frame: Blinded assessors will conduct evaluations at baseline, week 12 , and week 20.
Stroke Self-Efficacy Questionnaire (SSEQ)
The SSEQ is a 13-item self-report scale assessing stroke survivors' confidence in performing daily activities and managing post-stroke challenges. Each item is rated from 0 (not at all confident) to 4 (very confident). Total score ranges from 0 to 52. Higher scores indicate greater self-efficacy.
Time frame: Blinded assessors will conduct evaluations at baseline, week 12 , and week 20.
Fugl-Meyer Motor Assessment-Lower Extremity
To assess motor recovery, Fugl-Meyer Motor Assessment-Lower Extremity will be used, it score rangefrom 0 to 34; a high score is indicative of good motor recovery
Time frame: Blinded assessors will conduct evaluations at baseline, week 12 , and week 20.
6-Minute Walk Test
Walking endurance will be assessed using the 6-Minute Walk Test. The participants will be allowed to use assistive devices, which will be documented and kept consistent across all of the time points.
Time frame: Blinded assessors will conduct evaluations at baseline, week 12 , and week 20.
Physical Activity Enjoyment Scale (PAES)
The PAES will be used to measure the participants' exercise enjoyment (score range: 0-56). A high score indicates a high level of activity enjoyment.
Time frame: Blinded assessors will conduct evaluations at week 6 and at week 12.
Behavioral Regulation In Exercise Questionnaire (BREQ-2)
The BREQ-2 includes 19 items. Each item is rated on a 5-point Likert scale ranging from 0 ("not true for me") to 4 ("very true for me"). Higher scores reflect higher exercise motivation.
Time frame: Blinded assessors will conduct evaluations at week 1, week 12, and week 20.
Mini Balance Evaluation Systems Test (MiniBEST)
The Mini-BESTest consists of 14 items, including the Timed Up and Go test, with a maximum total score of 28 points. Higher scores indicate better balance performance.
Time frame: Blinded assessors will conduct evaluations at baseline, week 12 , and week 20.
Short Physical Performance Battery (SPPB)
The SPPB comprises three components: balance tests (including side-by-side, semi-tandem, and tandem stances), a gait speed test, and a five-times sit-to-stand test. Each component is scored on a scale from 0 to 4, with a total possible score ranging from 0 to 12. Higher scores indicate better physical performance.
Time frame: Blinded assessors will conduct evaluations at baseline, week 12 , and week 20.
Plan to share: Undecided
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The Hong Kong Polytechnic University