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临床试验/NCT06554665
NCT06554665招募中不适用

Powering Up Stroke Rehabilitation Through High-Intensity Interval Training

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2024年8月20日最近更新:
适应症

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

入选标准

  • 未提供

排除标准

  • 未提供

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 Strength (Nm) at Week 12(Baseline and Week 12)
  • Change from Baseline in Muscle Power at Week 24(Baseline and Week 24)
  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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