Clinical trial NCT01597960: Yoga And Cardiovascular Health Trial
Official title: Yoga And Cardiovascular Health Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: London School of Hygiene and Tropical Medicine
First posted: 2012-05-15
Enrollment: 80
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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.

Primary outcomes:
measure: Cardiopulmonary function
timeFrame: Week 0 (pre intervention) and week 12 (post intervention)
Secondary outcomes:
measure: Blood pressure
timeFrame: Week 0 (pre intervention), week 1 (pre & post 1st yoga class), and week 12 (post intervention)
measure: Heart rate and heart rate variability
timeFrame: Week 0 (pre intervention), week 1 (pre & post 1st yoga class), and week 12 (post intervention)
measure: Stress hormones
timeFrame: Week 0 (pre intervention), week 1 (pre & post 1st yoga class), and week 12 (post intervention)
measure: Exercise capacity
timeFrame: Week 0 (pre intervention), week 1 (pre & post 1st yoga class), and week 12 (post intervention)
measure: Body fat
timeFrame: Week 0 (pre intervention) and week 12 (post intervention)
measure: Glucose and lipids
timeFrame: Week 0 (pre intervention) and week 12 (post intervention)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: International Centre for Circulatory Health
Study officials:
affiliation: Imperial College London
name: Nishi Chaturvedi
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.