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NCT Number: NCT07273058

Effect of HIIT on Post-Stroke Fatigue

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Kowloon, Hong Kong

Location status: Recruiting

Location contact

Meizhen Huang

CONTACT

[email protected]

+852 0000000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HIIT

Behavioral

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.

MICT

Behavioral

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.

Stretching

Behavioral

The stretching intervention will consist of 30 minutes of whole-body stretching. Participants will attend three sessions per week over a 12-week period.

Primary outcomes

  1. Eligibility rate (%)

    Time frame: Through study completion, an average of 12 weeks.

  2. Recruitment rate (number of participants per month)

    Time frame: Through study completion, an average of 12 weeks.

  3. Compliance with HIIT (%)

    Time frame: From baseline to week 12

  4. Fidelity to the HIIT protocol (%)

    Time frame: From baseline to week 12

  5. Retention of the intervention (%)

    Time frame: From baseline to week 12

  6. Adverse events (number of events)

    Time frame: From baseline to week 12

  7. Acceptability (qualitative)

    Time frame: At week 12

Secondary outcomes

  1. Fatigue Severity Scale (FSS)

    Time frame: 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.

  2. Multidimensional Fatigue Inventory (MDI)

    Time frame: 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.

  3. Short Form-36 Health Survey (SF-36)

    Time frame: 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.

  4. Inflammatory biomarkers

    Time frame: 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 outcomes

  1. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 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.

  2. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 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.

  3. Stroke Self-Efficacy Questionnaire (SSEQ)

    Time frame: 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.

  4. Fugl-Meyer Motor Assessment-Lower Extremity

    Time frame: 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

  5. 6-Minute Walk Test

    Time frame: 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.

  6. Physical Activity Enjoyment Scale (PAES)

    Time frame: 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.

  7. Behavioral Regulation In Exercise Questionnaire (BREQ-2)

    Time frame: 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.

  8. Mini Balance Evaluation Systems Test (MiniBEST)

    Time frame: 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.

  9. Short Physical Performance Battery (SPPB)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fong Sze Chung

CONTACT

[email protected]

Mei Zhen Prof. Huang

CONTACT

[email protected]

+852 00000000

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

Effect of High-Intensity Interval Training Intervention on Post-Stroke Fatigue in Chronic Stroke Survivors: A Pilot Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 9, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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