Powering Up Stroke Rehabilitation Through HIIT

The Hong Kong Polytechnic University

Status: Enrolling

Conditions: Stroke

Treatments: Behavioral: High-intensity Interval Training; Behavioral: Moderate-Intensity Continuous Training; Behavioral: Stretching

Study type: Interventional

Funder types: Other

Identifiers

NCT06554665

HSEARS20230720002

Details and patient eligibility

About

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.

Enrollment: 66 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 3 patient groups

High-intensity interval training

Experimental group

Description:

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.

Treatment:

Behavioral: High-intensity Interval Training

Moderate-intensity continuous training

Active Comparator group

Description:

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.

Treatment:

Behavioral: Moderate-Intensity Continuous Training

Stretching

Active Comparator group

Description:

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

Treatment:

Behavioral: Stretching