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临床试验/NCT01597960
NCT01597960已完成不适用

Yoga And Cardiovascular Health Trial

Imperial College London2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2012年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
Cardiopulmonary function

研究概览

简要总结

The benefits of alternative therapeutic approaches, such as yoga, are poorly understood and this is particularly true of the beneficial effects on cardiovascular disease (CVD) risk. It is hoped that a better understanding of the value of this therapy will provide a sound scientific basis for including yoga in mainstream clinical practice. The investigators propose to study a group of 80 participants (40 Indian Asians and 40 Europeans) recruited from a cardiac rehabilitation programme in West London post-angioplasty as treatment for an acute coronary syndrome. Those who agree will undergo a series of baseline and follow-up measurements. 20 Indian Asians and 20 Europeans will be randomized to the yoga intervention plus their standard cardiac rehabilitation programme (usual care), and the remaining 20 Indian Asians and 20 Europeans will be randomized to usual care alone. Baseline and follow-up measurements will be performed on all participants. In order to determine the acute effects of yoga the group randomised to the yoga intervention will also undergo a series of acute tests before and after their first yoga session.

详细描述

The benefits of alternative therapeutic approaches, such as yoga, are poorly understood and this is particularly true of the beneficial effects on cardiovascular disease (CVD) risk. It is hoped that a better understanding of the value of this therapy will provide a sound scientific basis for including yoga in mainstream clinical practice. The investigators propose to study a group of 80 participants (40 Indian Asians and 40 Europeans) recruited from a cardiac rehabilitation programme in West London post-angioplasty as treatment for an acute coronary syndrome. Those who agree will undergo a series of baseline and follow-up measurements. 20 Indian Asians and 20 Europeans will be randomized to the yoga intervention plus their standard cardiac rehabilitation programme (usual care), and the remaining 20 Indian Asians and 20 Europeans will be randomized to usual care alone. Baseline and follow-up measurements will be performed on all participants; these include: Demographic & health questionnaire, Lifestyle questionnaires focusing on diet and exercise, Fasting bloods sampling (for cardiovascular risk factors and markers), Saliva sampling (x 5 samples for salivary cortisol and alpha-amylase), Anthropometrics - height, weight and waist and hip circumference, Bioimpedence - measurement of total body fat, 3D and Doppler echocardiography, Carotid IMT, Resting brachial blood pressure, Central blood pressure (tonometery at the radial artery), Pulse Wave Velocity, 12 lead ECG, Cardiopulmonary exercise testing, Combined 24hr BP & ECG monitor, Accelerometer (3 days). In order to determine the acute effects of yoga the group randomised to the yoga intervention will also undergo a series of acute tests before and after their first yoga session. These include: Exercise capacity, Saliva sampling (x 5 samples for salivary cortisol and alpha-amylase) and combined 24hr BP & ECG monitor.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
35 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 35-80 years.
  • Male or female.
  • European or Indian Asian descent.
  • Able to understand English or Punjabi.
  • Referred to a cardiac rehabilitation programme in West London post-angioplasty as treatment for an acute coronary syndrome.

排除标准

  • Adults under 35 years or above 80 years.
  • Adults aged 35-80 years who are not competent to give consent.
  • Co-morbid disease or mobility limitations that would preclude participation in cardiac rehabilitation and our investigations.

结局指标

主要结局

Cardiopulmonary function

时间窗: Week 0 (pre intervention) and week 12 (post intervention)

To perform a mechanistic study that determines the acute and chronic effects of yoga on cardiopulmonary function, autonomic function, blood pressure and heart rate.

次要结局

  • Stress hormones(Week 0 (pre intervention), week 1 (pre & post 1st yoga class), and week 12 (post intervention))
  • Glucose and lipids(Week 0 (pre intervention) and week 12 (post intervention))
  • Blood pressure(Week 0 (pre intervention), week 1 (pre & post 1st yoga class), and week 12 (post intervention))
  • Heart rate and heart rate variability(Week 0 (pre intervention), week 1 (pre & post 1st yoga class), and week 12 (post intervention))
  • Body fat(Week 0 (pre intervention) and week 12 (post intervention))
  • Exercise capacity(Week 0 (pre intervention), week 1 (pre & post 1st yoga class), and week 12 (post intervention))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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