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临床试验/NCT06474832
NCT06474832尚未招募不适用

Effects of High Intensity Interval Training on Cardiorespiratory Fitness and Gait Quality in People With Chronic Stroke

National Yang Ming Chiao Tung University2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
32
试验地点
2
主要终点
Gait symmetry index (SI)

研究概览

简要总结

Both gait and cardiovascular dysfunction are primary factors limiting community ambulation for stroke individuals. Increased gait variability and asymmetry contributes to a higher risk of falls, leading to reduced physical activity, decreased cardiorespiratory endurance, and increased walking economy and sympathetic nervous system activity, thereby potentially triggering secondary strokes. Previous studies have primarily focused on the significant improvements in walking endurance and speed with high-intensity interval training (HIIT) on a treadmill, leaving a gap in understanding the effects of HIIT on oxygen uptake efficiency slope (OUES) and gait quality for stroke individuals using a stationary bicycle ergometer. Therefore, the purpose of this study is to investigate the effects of HIIT using a stationary bicycle ergometer on improving cardiorespiratory fitness and gait quality in individuals with chronic stroke.

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
18 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18-69 years
  • At least 6 months post-stroke
  • Functional Ambulation Category (FAC) ≥ 3
  • Mini-Mental State Examination (MMSE) ≥ 24
  • Able to walk 10 meters overground with or without assistive devices

排除标准

  • Unstable cardiopulmonary conditions within the last 3 months
  • Other chronic neurological disorders
  • Contraindications to exercise as recommended by the American College of Sports Medicine (ACSM)
  • Severe lower limb spasticity (Modified Ashworth Scale > 2 points)
  • Implanted pacemaker or cardioverter defibrillator

结局指标

主要结局

Gait symmetry index (SI)

时间窗: Change from baseline at 8 weeks

Use the GAITRite system to assess the symmetry of spatial and temporal gait parameters. During the assessment, participants will be asked to walk three times. Calculate the symmetry index using the mean. SI = (affected side - unaffected side) / (1/2 \* (affected side + unaffected side)) \* 100%

Gait variability

时间窗: Change from baseline at 8 weeks

Using GAITRite system to measure coefficient of variation. During the assessment, participants will be asked to walk three times. The mean and standard deviation will be used to calculate the coefficient of variation (CV). CV = standard deviation / mean \* 100%

Oxygen uptake efficiency slope (OUES): cardiovascular fitness

时间窗: Change from baseline at 8 weeks

Perform symptom-limited exercise testing on a stationary bike using an incremental protocol. Maintain a pedal rate of 50-60 rpm, starting with an initial resistance of 50 watts. Increase the resistance by 25 watts every 2 minutes until the participant experiences exercise discomfort. OUES = Oxygen uptake / Log10 \* Minute ventilation

次要结局

  • Heart rate recovery (HRR): cardiovascular fitness-(Change from baseline at 8 weeks)
  • 6 minutes walking distance (6MWD): cardiovascular fitness(Change from baseline at 8 weeks)
  • Minute ventilation (VE) / carbon dioxide production (VCO2) slope: cardiovascular fitness(Change from baseline at 8 weeks)
  • Peak oxygen consumption (VO2peak): cardiovascular fitness(Change from baseline at 8 weeks)
  • Blood pressure (BP): cardiovascular fitness(Change from baseline at 8 weeks)
  • International Physical Activity Questionnaire (IPAQ) - Taiwan Physical Activity Questionnaire (Short Form)(Change from baseline at 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yea-Ru Yang

Professor

National Yang Ming Chiao Tung University

研究点 (2)

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