Powering Up Stroke Rehabilitation Through HIIT

NCT ID: NCT06554665

Last Updated: 2025-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-20

Study Completion Date

2026-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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High-intensity interval training

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.

Group Type EXPERIMENTAL

High-intensity Interval Training

Intervention Type BEHAVIORAL

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

Moderate-intensity continuous training

The MICT session will consist of a 3-minute warm-up, a main exercise that is isoenergetic with the HIIT session (lasting approximately 30 minutes), and a 2-minute cool-down. The intensity during the main exercise for MICT will remain constant throughout the session.

Group Type ACTIVE_COMPARATOR

Moderate-Intensity Continuous Training

Intervention Type BEHAVIORAL

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

Stretching

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

Group Type ACTIVE_COMPARATOR

Stretching

Intervention Type BEHAVIORAL

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

Interventions

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High-intensity Interval Training

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

Intervention Type BEHAVIORAL

Moderate-Intensity Continuous Training

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

Intervention Type BEHAVIORAL

Stretching

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Men and postmenopausal women aged 50-80 years
* 1-5 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)

Exclusion Criteria

* 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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Hong Kong Polytechnic University

Kowloon, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Chen Xu, PhD student

Role: CONTACT

Meizhen Huang, PhD

Role: CONTACT

Facility Contacts

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Chen Xu, PhD student

Role: primary

Meizhen Huang, PhD

Role: backup

Other Identifiers

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HSEARS20230720002

Identifier Type: -

Identifier Source: org_study_id

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