Yoga And Cardiovascular Health Trial (YACHT)

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease
• Intervention / Treatment: Other: Yoga

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, W2 1LA
    • International Centre for Circulatory Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Yoga 12 week programme; 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Imperial College London
• Collaborators: London School of Hygiene and Tropical Medicine
• Investigators: Principal Investigator: Nishi Chaturvedi, Imperial College London

Publications and helpful links

General Publications

• Tillin T, Tuson C, Sowa B, Chattopadhyay K, Sattar N, Welsh P, Roberts I, Ebrahim S, Kinra S, Hughes A, Chaturvedi N. Yoga and Cardiovascular Health Trial (YACHT): a UK-based randomised mechanistic study of a yoga intervention plus usual care versus usual care alone following an acute coronary event. BMJ Open. 2019 Nov 3;9(11):e030119. doi: 10.1136/bmjopen-2019-030119.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: May 8, 2012
• First Submitted That Met QC Criteria: May 14, 2012
• First Posted (Estimate): May 15, 2012

Study Record Updates

• Last Update Posted (Estimate): November 11, 2016
• Last Update Submitted That Met QC Criteria: November 10, 2016
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 12/LO/0597

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED