South Asian Yoga and Exercise Trial (SAYET)
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|ClinicalTrials.gov Identifier: NCT01766453|
Recruitment Status : Completed
First Posted : January 11, 2013
Last Update Posted : May 20, 2015
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:
- 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?
- 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|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
- Visceral adipose tissue [ Time Frame: 12 weeks ]Visceral adipose tissue will be assessed with multi-slice computed tomography
- Cardiometabolic risk factors [ Time Frame: 12 weeks ]Blood will be drawn and assessed for lipids, glucose, insulin, CRP, adiponectin and ALT
- Body Composition [ Time Frame: 12 weeks ]DEXA scans will be used to assess body fat distribution and lean body mass
- Maximal Aerobic Fitness [ Time Frame: 12 weeks ]A Bruce protocol treadmill test with metabolic data will be used to assess aerobic fitness
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 ClinicalTrials.gov identifier (NCT number): NCT01766453
|Canada, British Columbia|
|Simon Fraser University|
|Vancouver, British Columbia, Canada, V6B5K3|
|Principal Investigator:||Scott A Lear, PhD||Simon Fraser University|