Clinical trial NCT06554665: Powering Up Stroke Rehabilitation Through HIIT
Official title: Powering Up Stroke Rehabilitation Through High-Intensity Interval Training
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 66
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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, cardio-autonomic response, and psychosocial response.


Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in Muscle Power at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change from Baseline in Muscle Power at Week 24
timeFrame: Baseline and Week 24
measure: Change from Baseline in Muscle Strength (Nm) at Week 12
timeFrame: Baseline and Week 12
measure: Change from Baseline in Muscle Strength (Nm) at Week 24
timeFrame: Baseline and Week 24
measure: Change from Baseline in Muscle Strength (kg) at Week 12
timeFrame: Baseline and Week 12
measure: Change from Baseline in Muscle Strength (kg) at Week 24
timeFrame: Baseline and Week 24
measure: Change from Baseline in Body Composition (kg) at Week 12
timeFrame: Baseline and Week 12
measure: Change from Baseline in Body Composition (kg) at Week 24
timeFrame: Baseline and Week 24
measure: Change from Baseline in Body Composition (%) at Week 12
timeFrame: Baseline and Week 12
measure: Change from Baseline in Body Composition (%) at Week 24
timeFrame: Baseline and Week 24
measure: Change from Baseline in Biomarkers at Week 12
timeFrame: Baseline and Week 12
measure: Change from Baseline in Biomarkers at Week 24
timeFrame: Baseline and Week 24
measure: Change from Baseline in Motor Function at Week 12
timeFrame: Baseline and Week 12
measure: Change from Baseline in Motor Function at Week 24
timeFrame: Baseline and Week 24
measure: Change from Baseline in Motor Function (meters) at Week 12
timeFrame: Baseline and Week 12
measure: Change from Baseline in Motor Function (meters) at Week 24
timeFrame: Baseline and Week 24
measure: Change from Baseline in Balance Function at Week 12
timeFrame: Baseline and Week 12
measure: Change from Baseline in Balance Function at Week 24
timeFrame: Baseline and Week 24
measure: Change from Baseline in Cardiopulmonary Response at Week 12
timeFrame: Baseline and Week 12
measure: Change from Baseline in Cardiopulmonary Response at Week 24
timeFrame: Baseline and Week 24
measure: Change from Baseline in Cardio-autonomic Response at Week 12
timeFrame: Baseline and Week 12
measure: Change from Baseline in Cardio-autonomic Response at Week 24
timeFrame: Baseline and Week 24
measure: Change from Baseline in Psychosocial Responses at Week 12
timeFrame: Baseline and Week 12
measure: Change from Baseline in Psychosocial Responses at Week 24
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
city: Kowloon
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
References: