NCT01597960

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 15, 2012

Completed
17 days until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

November 11, 2016

Status Verified

June 1, 2012

Enrollment Period

10 months

First QC Date

May 8, 2012

Last Update Submit

November 10, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Blood pressure

    Week 0 (pre intervention), week 1 (pre & post 1st yoga class), and week 12 (post intervention)

  • Heart rate and heart rate variability

    Week 0 (pre intervention), week 1 (pre & post 1st yoga class), and week 12 (post intervention)

  • Stress hormones

    Week 0 (pre intervention), week 1 (pre & post 1st yoga class), and week 12 (post intervention)

  • Exercise capacity

    Week 0 (pre intervention), week 1 (pre & post 1st yoga class), and week 12 (post intervention)

  • Body fat

    Week 0 (pre intervention) and week 12 (post intervention)

  • +1 more secondary outcomes

Study Arms (2)

Yoga 12 week programme

ACTIVE COMPARATOR

Usual care (standard cardiac rehabilitation programme) plus yoga intervention.

Other: Yoga

Usual care

NO INTERVENTION

Usual care (standard cardiac rehabilitation programme) only.

Interventions

YogaOTHER

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).

Yoga 12 week programme

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Centre for Circulatory Health

London, W2 1LA, United Kingdom

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Yoga

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Nishi Chaturvedi

    Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2012

First Posted

May 15, 2012

Study Start

June 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

November 11, 2016

Record last verified: 2012-06

Locations