Yoga And Cardiovascular Health Trial

Cardiovascular Disease Clinical Trial

— YACHT  

Official title:

Yoga And Cardiovascular Health Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01597960
• Other study ID #: 12/LO/0597
• Status: Completed
• Phase: N/A
• First received: May 8, 2012
• Last updated: November 10, 2016
• Start date: June 2012
• Est. completion date: April 2013

Study information

• Verified date: June 2012
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

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).

Locations

Country	Name	City	State
United Kingdom	International Centre for Circulatory Health	London

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	London School of Hygiene and Tropical Medicine

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No