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Recruiting NCT06554665

Powering Up Stroke Rehabilitation Through HIIT

No phase Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High-intensity Interval Training, Moderate-Intensity Continuous Training, Stretching.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: 50 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Powering Up Stroke Rehabilitation Through High-Intensity Interval Training

Overview

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.

Interventions

  • Behavioral High-intensity Interval Training
    There will be three sessions per week for 12 consecutive weeks, totaling 36 training sessions.
  • Behavioral Moderate-Intensity Continuous Training
    There will be three sessions per week for 12 consecutive weeks, totaling 36 training sessions.
  • Behavioral Stretching
    There will be three sessions per week for 12 consecutive weeks, totaling 36 training sessions.

Primary outcome measures

  • Change from Baseline in Muscle Power at Week 12 [Time frame: Baseline and Week 12]
Secondary outcome measures (12)
  • Change from Baseline in Muscle Power at Week 24 [Time frame: Baseline and Week 24]
  • Change from Baseline in Muscle Strength (Nm) at Week 12 [Time frame: Baseline and Week 12]
  • Change from Baseline in Muscle Strength (Nm) at Week 24 [Time frame: Baseline and Week 24]
  • Change from Baseline in Muscle Strength (kg) at Week 12 [Time frame: Baseline and Week 12]
  • Change from Baseline in Muscle Strength (kg) at Week 24 [Time frame: Baseline and Week 24]
  • Change from Baseline in Body Composition (kg) at Week 12 [Time frame: Baseline and Week 12]
  • Change from Baseline in Body Composition (kg) at Week 24 [Time frame: Baseline and Week 24]
  • Change from Baseline in Body Composition (%) at Week 12 [Time frame: Baseline and Week 12]
  • Change from Baseline in Body Composition (%) at Week 24 [Time frame: Baseline and Week 24]
  • Change from Baseline in Biomarkers at Week 12 [Time frame: Baseline and Week 12]
  • Change from Baseline in Biomarkers at Week 6 [Time frame: Baseline and Week 6]
  • Change from Baseline in Motor Function at Week 12 [Time frame: Baseline and Week 12]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • The Hong Kong Polytechnic University — Kowloon

Identifiers

NCT: NCT06554665 · HSEARS20230720002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗