Effect of HIIT on Post-Stroke Fatigue

NCT07273058 | Recruiting

• 1 other identifier: HSEARS20241002001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (4)

• Fatigue Severity Scale (FSS)

  Blinded assessors will conduct evaluations at baseline, week 12 , and week 20.

• 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.

• Inflammatory biomarkers

  Blinded assessors will conduct evaluations at baseline, week 6, and week 12.

Other Outcomes (9)

• Hospital Anxiety and Depression Scale (HADS)

  Blinded assessors will conduct evaluations at baseline, week 12 , and week 20.

• Pittsburgh Sleep Quality Index (PSQI)

  Blinded assessors will conduct evaluations at baseline, week 12 , and week 20.

• Stroke Self-Efficacy Questionnaire (SSEQ)

  Blinded assessors will conduct evaluations at baseline, week 12 , and week 20.

Study Arms (3)

HIIT

EXPERIMENTAL

Behavioral: HIIT

MICT

ACTIVE COMPARATOR

Behavioral: MICT

Stretching

ACTIVE COMPARATOR

Behavioral: stretching

Interventions

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.

HIIT

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.

MICT

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.

Stretching

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Kowloon, Hong Kong

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Mei Zhen Prof. Huang

CONTACT

+852 00000000; mei-zhen.huang@polyu.edu.hk

Fong Sze Chung

CONTACT

fschung@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: December 9, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: December 9, 2025

Record last verified: 2025-11

Locations

HK (1)