Powering Up Stroke Rehabilitation Through HIIT

NCT06554665 | Recruiting

• 1 other identifier: HSEARS20230720002
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: To investigate the effects of high-intensity interval training (HIIT) on musculoskeletal fitness in chronic stroke survivors. Hypothesis to be tested: HIIT, performed on a recumbent stepper, will significantly enhance muscle power in chronic stroke survivors when compared with moderate-intensity continuous training (MICT) Design and subjects: Assessor-blinded, stratified, randomised, placebo-controlled clinical trial involving eligible 66 chronic stroke survivors. Interventions: Participants will be randomly allocated to one of three groups: the HIIT group, the MICT group, or a stretching group (active control). Each group will attend sessions three times per week for 12 consecutive weeks, totaling 36 training sessions. Main outcome measures: Assessments will be conducted at baseline, at mid-term of the intervention (week 6), at the end of the intervention (week 12), and at a 12-week follow-up (week 24). The primary outcome measure will be muscle power. Secondary outcome measures will include muscle strength, body composition, biomarkers, motor function, balance function, cardiorespiratory response, and psychosocial response.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Muscle Power at Week 12

  Muscle power (watt) of knee extensors on both the paretic and nonparetic sides will be measured using the isokinetic dynamometer. Change=(Week 12 Level - Baseline Level)

  Baseline and Week 12

Secondary Outcomes (21)

• Change from Baseline in Muscle Power at Week 24

  Baseline and Week 24

• Change from Baseline in Muscle Strength (Nm) at Week 12

  Baseline and Week 12

• Change from Baseline in Muscle Strength (Nm) at Week 24

  Baseline and Week 24

• Change from Baseline in Muscle Strength (kg) at Week 12

  Baseline and Week 12

• Change from Baseline in Muscle Strength (kg) at Week 24

  Baseline and Week 24

Study Arms (3)

High-intensity interval training

EXPERIMENTAL

The HIIT session will consist of a 3-minute warm-up, a 20-minute main exercise, and a 2-minute cool-down. The main exercise for HIIT will include ten high-intensity intervals, interspersed with ten low-intensity intervals.

Behavioral: High-intensity Interval Training

Moderate-intensity continuous training

ACTIVE COMPARATOR

The MICT session will consist of a 3-minute warm-up, a main exercise that approximately matches the total workload of the HIIT session (lasting about 30 minutes), and a 2-minute cool-down. The intensity during the main exercise for MICT will remain below the vigorous level by progressively adjusting the workload throughout the intervention period.

Behavioral: Moderate-Intensity Continuous Training

Stretching

ACTIVE COMPARATOR

The stretching group will receive 25 minutes of whole-body stretching.

Behavioral: Stretching

Interventions

High-intensity Interval Training BEHAVIORAL

There will be three sessions per week for 12 consecutive weeks, totaling 36 training sessions.

High-intensity interval training

Moderate-Intensity Continuous Training BEHAVIORAL

There will be three sessions per week for 12 consecutive weeks, totaling 36 training sessions.

Moderate-intensity continuous training

Stretching BEHAVIORAL

There will be three sessions per week for 12 consecutive weeks, totaling 36 training sessions.

Stretching

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and postmenopausal women aged 50-80 years
• years following the first-ever stroke confirmed by magnetic resonance imaging or computed tomography
• Able to walk 10 meters independently with or without a walking aid
• Class I or II according to the New York Heart Association Functional Classification (no limitation or slight limitation of physical activity due to symptoms during ordinary physical activity)

You may not qualify if:

• Presence of other neurological comorbidities, significant liver or renal diseases, thyroid or parathyroid diseases, rheumatoid arthritis, or a fracture within the past 6 months
• Undergoing osteoporosis treatments within the past 3 years, use of oral corticosteroids for more than 3 months within the past year, or botulinum toxin injections in the paretic lower limb within the past 6 months
• Participation in ongoing stroke rehabilitation services or structured exercise programme
• Cognitive or communication issues that could limit the ability to follow instructions
• Contraindications to HIIT, graded exercise testing, or failure to pass medical clearance from a specialist

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Kowloon, Hong Kong

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Chen Xu, PhD student

CONTACT

00000000; rschen.xu@connect.polyu.hk

Meizhen Huang, PhD

CONTACT

00000000; mei-zhen.huang@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: SPONSOR

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 15, 2024
• Study Start: August 20, 2024
• Primary Completion: April 6, 2026
• Study Completion: April 30, 2026
• Last Updated: March 27, 2026

Record last verified: 2025-09

Locations

HK (1)