Effect of HIIT on Post-Stroke Fatigue

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

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 Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Behavioral: HIIT; Behavioral: MICT; Behavioral: stretching

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mei Zhen Prof. Huang; Phone Number: +852 00000000; Email: mei-zhen.huang@polyu.edu.hk
• Study Contact Backup: Name: Fong Sze Chung; Email: fschung@polyu.edu.hk

Study Locations

• Hong Kong
  • Kowloon, Hong Kong
    • Recruiting
    • The Hong Kong Polytechnic University
    • Contact: Meizhen Huang; Phone Number: +852 0000000; Email: mei-zhen.huang@polyu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MICT	Behavioral: MICT; 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.
Active Comparator: Stretching	Behavioral: stretching; The stretching intervention will consist of 30 minutes of whole-body stretching. Participants will attend three sessions per week over a 12-week period.
Experimental: HIIT	Behavioral: HIIT; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Eligibility rate (%)	Through study completion, an average of 12 weeks.
Recruitment rate (number of participants per month)	Through study completion, an average of 12 weeks.
Compliance with HIIT (%)	From baseline to week 12
Fidelity to the HIIT protocol (%)	From baseline to week 12
Retention of the intervention (%)	From baseline to week 12
Adverse events (number of events)	From baseline to week 12
Acceptability (qualitative)	At week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Blinded assessors will conduct evaluations at baseline, week 6, and week 12.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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	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.	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.	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.	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.	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.	Blinded assessors will conduct evaluations at baseline, week 12 , and week 20.

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: September 16, 2025
• First Submitted That Met QC Criteria: December 8, 2025
• First Posted (Estimated): December 9, 2025

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: HSEARS20241002001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No