Yoga And Cardiovascular Health Trial (YACHT)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cardiovascular Health |
Other: Yoga Other: Usual care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Yoga And Cardiovascular Health Trial |
- Cardiopulmonary function [ Time Frame: Week 0 (pre intervention) and week 12 (post intervention) ] [ Designated as safety issue: No ]To perform a mechanistic study that determines the acute and chronic effects of yoga on cardiopulmonary function, autonomic function, blood pressure and heart rate.
- Blood pressure [ Time Frame: Week 0 (pre intervention), week 1 (pre & post 1st yoga class), and week 12 (post intervention) ] [ Designated as safety issue: No ]Blood pressure will be measured at baseline, at the beginning and end of the first yoga class, and immediately after the 12 week intervention.
- Heart rate and heart rate variability [ Time Frame: Week 0 (pre intervention), week 1 (pre & post 1st yoga class), and week 12 (post intervention) ] [ Designated as safety issue: No ]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.
- Stress hormones [ Time Frame: Week 0 (pre intervention), week 1 (pre & post 1st yoga class), and week 12 (post intervention) ] [ Designated as safety issue: No ]Stress hormones will be measured at baseline, at the beginning and end of the first yoga class, and immediately after the 12 week intervention.
- Exercise capacity [ Time Frame: Week 0 (pre intervention), week 1 (pre & post 1st yoga class), and week 12 (post intervention) ] [ Designated as safety issue: No ]Exercise capacity will be measured at baseline, at the beginning and end of the first yoga class, and immediately after the 12 week intervention.
- Body fat [ Time Frame: Week 0 (pre intervention) and week 12 (post intervention) ] [ Designated as safety issue: No ]Body fat will be measured at baseline and immediately after the 12 week intervention.
- Glucose and lipids [ Time Frame: Week 0 (pre intervention) and week 12 (post intervention) ] [ Designated as safety issue: No ]Glucose and lipids will be measured at baseline and immediately after the 12 week intervention.
| Estimated Enrollment: | 80 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Yoga
Usual care (standard cardiac rehabilitation programme) plus yoga intervention.
|
Other: Yoga
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).
|
|
No Intervention: Usual care
Usual care (standard cardiac rehabilitation programme) only.
|
Other: Usual care
Those randomised to usual care alone will undergo the series of baseline and follow-up investigations (i.e. before and after their cardiac rehabilitation programme).
|
Eligibility| Ages Eligible for Study: | 35 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Claire S Tuson | 020 7594 5947 ext 45947 | c.tuson@imperial.ac.uk |
| United Kingdom | |
| International Centre for Circulatory Health | Not yet recruiting |
| London, United Kingdom, W2 1LA | |
| Contact: Claire S Tuson 020 75945947 ext 45947 c.tuson@imperial.ac.uk | |
| Principal Investigator: Nish Chaturvedi | |
| Principal Investigator: | Nishi Chaturvedi | Imperial College London |
More Information
No publications provided
| Responsible Party: | Imperial College London |
| ClinicalTrials.gov Identifier: | NCT01597960 History of Changes |
| Other Study ID Numbers: | 12/LO/0597 |
| Study First Received: | May 8, 2012 |
| Last Updated: | June 14, 2012 |
| Health Authority: | United Kingdom: Imperial College London |
ClinicalTrials.gov processed this record on June 18, 2013