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Yoga And Cardiovascular Health Trial (YACHT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Imperial College London.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01597960
First received: May 8, 2012
Last updated: June 14, 2012
Last verified: June 2012
  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

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01597960

Contacts
Contact: Claire S Tuson 020 7594 5947 ext 45947 c.tuson@imperial.ac.uk

Locations
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         
Sponsors and Collaborators
Imperial College London
London School of Hygiene and Tropical Medicine
Investigators
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 November 20, 2014