Effect of HIIT on Post-Stroke Fatigue

The Hong Kong Polytechnic University

Status: Enrolling

Conditions: Stroke

Treatments: Behavioral: MICT; Behavioral: stretching; Behavioral: HIIT

Study type: Interventional

Funder types: Other

Identifiers

NCT07273058

HSEARS20241002001

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

HIIT

Experimental group

Treatment:

Behavioral: HIIT

MICT

Active Comparator group

Treatment:

Behavioral: MICT

Stretching

Active Comparator group

Treatment:

Behavioral: stretching