South Asian Yoga and Exercise Trial (SAYET)

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. Identifier: NCT01766453
Recruitment Status : Completed
First Posted : January 11, 2013
Last Update Posted : May 20, 2015
Information provided by (Responsible Party):
Scott Lear, Simon Fraser University

Brief Summary:

South Asians have one of the highest rates of heart disease of all populations and a unique and deleterious obesity phenotype of increased body fat and inner-abdominal compared to those of European background. We have subsequently identified that this unique phenotype accounts for much of the increased heart disease risk in South Asians, with the greater amounts of inner abdominal fat being particularly implicated. In addition, South Asians in Canada have substantially lower levels of leisure-time physical activity.

At present, we do not know the answers to the following questions:

  1. Is a conventional (standard) physical activity program that has proven effective at reducing inner abdominal fat and heart disease risk factors in populations of European background be effective in South Asians?
  2. Is an alternative physical activity program commonly practiced by South Asians (such as bhangra dance) be effective at reducing inner abdominal fat and heart disease risk factors in South Asians? In this study, we will perform a randomized controlled trial of three conditions—gym-based standard exercise program (SE),bhangra dance exercise program (BE) and non-exercise control (NE).We will recruit 75 post-menopausal South Asian women with abdominal obesity and assign them randomly to one of the three groups (25 per group).

We anticipate that both the SE and BE programs will be superior to the NE group in terms of reducing VAT and CVD risk factors. Such findings will demonstrate that exercise is an effective method that favourably modifies the obesity phenotype of excess VAT in South Asians, and should be central to health promotion and disease prevention strategies.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Standard Exercise Behavioral: Bhangra dance exercise Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Utility of a Culturally Relevant or a Standard Exercise Program to Reduce Visceral Adipose Tissue and Cardiovascular Disease Risk in Abdominally Obese Postmenopausal South Asian Women
Study Start Date : April 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Non exercise control
Non exercise control will undergo baseline testing and follow up testing but will not participate in an exercise intervention.
Experimental: Standard Exercise
The standard exercise group will attend exercise sessions under the supervision of a Certified Personal Trainer. Intensity will increase every four weeks by 10% from 50-80% of maximal heart rate to ensure that exercise is progressive in nature. Participants will be provided with a heart rate monitor during their exercise sessions and have the option to perform the aerobic training on a treadmill, upright bike, elliptical machine or recumbent bike as long as heart rate is kept within the prescribed training intensity. Intensity, duration, resting and exercise heart rates will be recorded for each exercise session for the duration of the intervention to ensure compliance to the exercise program.
Behavioral: Standard Exercise
Aerobic exercise with a progressive increase in intensity over 12 weeks.

Experimental: Bhangra Dance Exercise
Bhangra dance classes taught be a certified instructor progressing in difficulty over the 12 week period. Bhangra dance is an Indian folk dance that consists of jumping and kicking of a high intensity. This group will attend exercise sessions under the supervision of a Bhangra Dance Instructor. The intensity of bhangra dance will be tracked through heart rate monitors worn by participants.
Behavioral: Bhangra dance exercise
Bhangra Dance classes taught by an instructor.

Primary Outcome Measures :
  1. Visceral adipose tissue [ Time Frame: 12 weeks ]
    Visceral adipose tissue will be assessed with multi-slice computed tomography

Secondary Outcome Measures :
  1. Cardiometabolic risk factors [ Time Frame: 12 weeks ]
    Blood will be drawn and assessed for lipids, glucose, insulin, CRP, adiponectin and ALT

  2. Body Composition [ Time Frame: 12 weeks ]
    DEXA scans will be used to assess body fat distribution and lean body mass

  3. Maximal Aerobic Fitness [ Time Frame: 12 weeks ]
    A Bruce protocol treadmill test with metabolic data will be used to assess aerobic fitness

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Post-menopausal South Asian women defined as not menstruating for the previous 12 consecutive months as assessed by self report
  • Waist circumference >80 cm (women), as identified as South Asian cut offs by International Diabetes Federation109
  • Able to read and write and understand English
  • Previously sedentary (<150 minutes of physical activity per week as assessed by accelerometry)
  • Weight stable (<2kg of weight change over the past 6 weeks)

Exclusion Criteria:

  • Taking medication that may affect study outcomes (lipid-lowering, antihypertensive, or hypoglycemic medications)
  • Unable to provide informed consent
  • Individuals > 136 kg (physical limitation of DXA scanner table)
  • Smokers (given the confounding association between smoking and adiposity)
  • Unable to participate in exercise sessions due to physical limitations or contra-indications to regular exercise as indicated on the baseline maximal exercise stress test
  • Individuals with known CVD or other known comorbidities (HIV, immune compromised condition, type 1 or 2 diabetes mellitus)
  • Another member of the household already participating in study

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 identifier (NCT number): NCT01766453

Canada, British Columbia
Simon Fraser University
Vancouver, British Columbia, Canada, V6B5K3
Sponsors and Collaborators
Simon Fraser University
Principal Investigator: Scott A Lear, PhD Simon Fraser University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Scott Lear, Professor, Simon Fraser University Identifier: NCT01766453     History of Changes
Other Study ID Numbers: SFU
First Posted: January 11, 2013    Key Record Dates
Last Update Posted: May 20, 2015
Last Verified: May 2015

Keywords provided by Scott Lear, Simon Fraser University:
South Asian
Visceral Adipose Tissue