Stroke
Conditions
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.
Interventions
BEHAVIORALHIIT
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.
BEHAVIORALMICT
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.
BEHAVIORALstretching
The stretching intervention will consist of 30 minutes of whole-body stretching. Participants will attend three sessions per week over a 12-week period.
Sponsors
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Eligibility rate (%) | Through study completion, an average of 12 weeks. |
| Acceptability (qualitative) | At week 12 |
| Adverse events (number of events) | From baseline to week 12 |
| Retention of the intervention (%) | From baseline to week 12 |
| Fidelity to the HIIT protocol (%) | From baseline to week 12 |
| Compliance with HIIT (%) | From baseline to week 12 |
| Recruitment rate (number of participants per month) | Through study completion, an average of 12 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Multidimensional Fatigue Inventory (MDI) | Blinded assessors will conduct evaluations at baseline, week 12 , and week 20. | 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. |
| Fatigue Severity Scale (FSS) | Blinded assessors will conduct evaluations at baseline, week 12 , and week 20. | 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. |
| Short Form-36 Health Survey (SF-36) | Blinded assessors will conduct evaluations at baseline, week 6, and week 12. | 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. |
| Inflammatory biomarkers | Blinded assessors will conduct evaluations at baseline, week 6, and week 12. | Inflammatory biomarkers will be quantified using enzyme-linked immunosorbent assay (ELISA) kits obtained from commercial suppliers, following the manufacturer's instructions. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Stroke Self-Efficacy Questionnaire (SSEQ) | Blinded assessors will conduct evaluations at baseline, week 12 , and week 20. | 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. |
| Pittsburgh Sleep Quality Index (PSQI) | Blinded assessors will conduct evaluations at baseline, week 12 , and week 20. | 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. |
| Mini Balance Evaluation Systems Test (MiniBEST) | Blinded assessors will conduct evaluations at baseline, week 12 , and week 20. | 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. |
| Behavioral Regulation In Exercise Questionnaire (BREQ-2) | Blinded assessors will conduct evaluations at week 1, week 12, and week 20. | 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. |
| Physical Activity Enjoyment Scale (PAES) | Blinded assessors will conduct evaluations at week 6 and at week 12. | 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. |
| 6-Minute Walk Test | Blinded assessors will conduct evaluations at baseline, week 12 , and week 20. | 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. |
| Short Physical Performance Battery (SPPB) | Blinded assessors will conduct evaluations at baseline, week 12 , and week 20. | 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. |
| Fugl-Meyer Motor Assessment-Lower Extremity | Blinded assessors will conduct evaluations at baseline, week 12 , and week 20. | 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 |
| Hospital Anxiety and Depression Scale (HADS) | Blinded assessors will conduct evaluations at baseline, week 12 , and week 20. | 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. |
Countries
Hong Kong
Contacts
Primary ContactMei Zhen Prof. Huang
Backup ContactFong Sze Chung
Outcome results
None listed