Yoga And Cardiovascular Health Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Yoga And Cardiovascular Health Trial

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Other: Yoga


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Yoga 12 week programme<br>Usual care (standard cardiac rehabilitation programme) plus yoga intervention. | Other: Yoga<br>* Those randomised to usual care plus the yoga intervention will be required to attend yoga classes twice a week for 12 weeks alongside their cardiac rehabilitation programme. There will be 24 yoga classes in total, of which, we require the participant to attend a minimum of 18. The yoga classes will be conducted by a teacher certified in yoga and cardiac rehabilitation and will encompass physical fitness (yoga poses), stress reduction (breath control and meditation) and positive lifestyle changes (diet, smoking and alcohol).<br>|
| No Intervention: Usual care<br>Usual care (standard cardiac rehabilitation programme) only. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiopulmonary function | To perform a mechanistic study that determines the acute and chronic effects of yoga on cardiopulmonary function, autonomic function, blood pressure and heart rate. | Week 0 (pre intervention) and week 12 (post intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Blood pressure will be measured at baseline, at the beginning and end of the first yoga class, and immediately after the 12 week intervention. | Week 0 (pre intervention), week 1 (pre & post 1st yoga class), and week 12 (post intervention) | 
| Heart rate and heart rate variability | Heart rate and heart rate variability will be measured at baseline, at the beginning and end of the first yoga class, and immediately after the 12 week intervention. | Week 0 (pre intervention), week 1 (pre & post 1st yoga class), and week 12 (post intervention) | 
| Stress hormones | Stress hormones will be measured at baseline, at the beginning and end of the first yoga class, and immediately after the 12 week intervention. | Week 0 (pre intervention), week 1 (pre & post 1st yoga class), and week 12 (post intervention) | 
| Exercise capacity | Exercise capacity will be measured at baseline, at the beginning and end of the first yoga class, and immediately after the 12 week intervention. | Week 0 (pre intervention), week 1 (pre & post 1st yoga class), and week 12 (post intervention) | 
| Body fat | Body fat will be measured at baseline and immediately after the 12 week intervention. | Week 0 (pre intervention) and week 12 (post intervention) | 
| Glucose and lipids | Glucose and lipids will be measured at baseline and immediately after the 12 week intervention. | Week 0 (pre intervention) and week 12 (post intervention) |