Effect of HIIT on Post-Stroke Fatigue

NCT ID: NCT07273058

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-15
• Study Completion Date: 2027-10-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

HIIT

Group Type: EXPERIMENTAL

HIIT

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

MICT

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

stretching

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Dr HUANG Mei Zhen

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Hong Kong Polytechnic University

Kowloon, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Mei Zhen Prof. Huang

Role: CONTACT

mei-zhen.huang@polyu.edu.hk

+852 00000000

Fong Sze Chung

Role: CONTACT

fschung@polyu.edu.hk

Facility Contacts

Meizhen Huang

Role: primary

mei-zhen.huang@polyu.edu.hk

+852 0000000

Other Identifiers

HSEARS20241002001

Identifier Type: -

Identifier Source: org_study_id