About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
High-intensity Interval Training
BehavioralThere will be three sessions per week for 12 consecutive weeks, totaling 36 training sessions.
Moderate-Intensity Continuous Training
BehavioralThere will be three sessions per week for 12 consecutive weeks, totaling 36 training sessions.
Stretching
BehavioralThere will be three sessions per week for 12 consecutive weeks, totaling 36 training sessions.
Treatment groups
Trial outcomes
Primary outcomes
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)
Secondary outcomes
Change from Baseline in Muscle Power at Week 24
Muscle power (watt) of knee extensors on both the paretic and nonparetic sides will be measured using the isokinetic dynamometer. Change=(Week 24 Level - Baseline Level)
Change from Baseline in Muscle Strength (Nm) at Week 12
Muscle strength (Nm) of knee extensors on both the paretic and nonparetic sides will be measured using the isokinetic dynamometer. Change=(Week 12 Level - Baseline Level)
Change from Baseline in Muscle Strength (Nm) at Week 24
Muscle strength (Nm) of knee extensors on both the paretic and nonparetic sides will be measured using the isokinetic dynamometer. Change=(Week 24 Level - Baseline Level)
Change from Baseline in Muscle Strength (kg) at Week 12
Handgrip strength (kg) on both sides will be measured using a handheld dynamometer. Change=(Week 12 Level - Baseline Level)
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