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Completed

NCT Number: NCT01597960

Yoga And Cardiovascular Health Trial

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.

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Key information

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

International Centre for Circulatory Health

London, W2 1LA, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

yoga

Other

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).

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • London School of Hygiene and Tropical Medicine

Registry information

Acronym: YACHT

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 15, 2012
Registry last updated
Nov 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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