Powering Up Stroke Rehabilitation Through High-Intensity Interval Training
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change from Baseline in Muscle Power at Week 12
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: High-intensity Interval Training (Behavioral)
Moderate-intensity continuous training
The MICT session will consist of a 3-minute warm-up, a main exercise that approximately matches the total workload of the HIIT session (lasting about 30 minutes), and a 2-minute cool-down. The intensity during the main exercise for MICT will remain below the vigorous level by progressively adjusting the workload throughout the intervention period.
干预措施: Moderate-Intensity Continuous Training (Behavioral)
Stretching
The stretching group will receive 25 minutes of whole-body stretching.
干预措施: Stretching (Behavioral)
结局指标
主要结局
Change from Baseline in Muscle Power at Week 12
时间窗: Baseline and 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)
次要结局
- Change from Baseline in Muscle Strength (kg) at Week 12(Baseline and Week 12)
- Change from Baseline in Muscle Strength (kg) at Week 24(Baseline and Week 24)
- Change from Baseline in Body Composition (kg) at Week 12(Baseline and Week 12)
- Change from Baseline in Body Composition (kg) at Week 24(Baseline and Week 24)
- Change from Baseline in Body Composition (%) at Week 12(Baseline and Week 12)
- Change from Baseline in Body Composition (%) at Week 24(Baseline and Week 24)
- Change from Baseline in Biomarkers at Week 12(Baseline and Week 12)
- Change from Baseline in Biomarkers at Week 6(Baseline and Week 6)
- Change from Baseline in Muscle Power at Week 24(Baseline and Week 24)
- Change from Baseline in Muscle Strength (Nm) at Week 12(Baseline and Week 12)
- Change from Baseline in Muscle Strength (Nm) at Week 24(Baseline and Week 24)
- Change from Baseline in Muscle Power at Week 24(Baseline and Week 24)
- Change from Baseline in Muscle Strength (Nm) at Week 12(Baseline and Week 12)
- Change from Baseline in Muscle Strength (Nm) at Week 24(Baseline and Week 24)
- Change from Baseline in Muscle Strength (kg) at Week 12(Baseline and Week 12)
- Change from Baseline in Muscle Strength (kg) at Week 24(Baseline and Week 24)
- Change from Baseline in Body Composition (kg) at Week 12(Baseline and Week 12)
- Change from Baseline in Body Composition (kg) at Week 24(Baseline and Week 24)
- Change from Baseline in Body Composition (%) at Week 12(Baseline and Week 12)
- Change from Baseline in Body Composition (%) at Week 24(Baseline and Week 24)
- Change from Baseline in Motor Function (meters) at Week 24(Baseline and Week 24)
- Change from Baseline in Biomarkers at Week 12(Baseline and Week 12)
- Change from Baseline in Motor Function (meters) at Week 12(Baseline and Week 12)
- Change from Baseline in Biomarkers at Week 6(Baseline and Week 6)
- Change from Baseline in Motor Function at Week 24(Baseline and Week 24)
- Change from Baseline in Balance Function at Week 12(Baseline and Week 12)
- Change from Baseline in Balance Function at Week 24(Baseline and Week 24)
- Change from Baseline in Motor Function at Week 12(Baseline and Week 12)
- Change from Baseline in Cardiopulmonary Response at Week 12(Baseline and Week 12)
- Change from Baseline in Cardiopulmonary Response at Week 24(Baseline and Week 24)
- Change from Baseline in Psychosocial Responses at Week 12(Baseline and Week 12)
- Change from Baseline in Psychosocial Responses at Week 24(Baseline and Week 24)