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Yoga And Cardiovascular Health Trial (YACHT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01597960
Recruitment Status : Completed
First Posted : May 15, 2012
Last Update Posted : November 11, 2016
Sponsor:
Collaborator:
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
Imperial College London

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Other: Yoga Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Yoga And Cardiovascular Health Trial
Study Start Date : June 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Cardiopulmonary function [ Time Frame: 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.


Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: Week 0 (pre intervention), week 1 (pre & post 1st yoga class), and week 12 (post intervention) ]
    Blood pressure will be measured at baseline, at the beginning and end of the first yoga class, and immediately after the 12 week intervention.

  2. Heart rate and heart rate variability [ Time Frame: Week 0 (pre intervention), week 1 (pre & post 1st yoga class), and week 12 (post intervention) ]
    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.

  3. Stress hormones [ Time Frame: Week 0 (pre intervention), week 1 (pre & post 1st yoga class), and week 12 (post intervention) ]
    Stress hormones will be measured at baseline, at the beginning and end of the first yoga class, and immediately after the 12 week intervention.

  4. Exercise capacity [ Time Frame: Week 0 (pre intervention), week 1 (pre & post 1st yoga class), and week 12 (post intervention) ]
    Exercise capacity will be measured at baseline, at the beginning and end of the first yoga class, and immediately after the 12 week intervention.

  5. Body fat [ Time Frame: Week 0 (pre intervention) and week 12 (post intervention) ]
    Body fat will be measured at baseline and immediately after the 12 week intervention.

  6. Glucose and lipids [ Time Frame: Week 0 (pre intervention) and week 12 (post intervention) ]
    Glucose and lipids will be measured at baseline and immediately after the 12 week intervention.


Eligibility Criteria
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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01597960


Locations
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United Kingdom
International Centre for Circulatory Health
London, United Kingdom, W2 1LA
Sponsors and Collaborators
Imperial College London
London School of Hygiene and Tropical Medicine
Investigators
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Principal Investigator: Nishi Chaturvedi Imperial College London
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01597960    
Other Study ID Numbers: 12/LO/0597
First Posted: May 15, 2012    Key Record Dates
Last Update Posted: November 11, 2016
Last Verified: June 2012
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Cardiovascular Diseases