South Asian Yoga and Exercise Trial (SAYET)
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 yoga) 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),yoga exercise program (YE) 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 YE 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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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|
- Visceral adipose tissue [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Visceral adipose tissue will be assessed with multi-slice computed tomography
- Cardiometabolic risk factors [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Blood will be drawn and assessed for lipids, glucose, insulin, CRP, adiponectin and ALT
- Body Composition [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]DEXA scans will be used to assess body fat distribution and lean body mass
- Maximal Aerobic Fitness [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]A Bruce protocol treadmill test will be used to assess aerobic fitness using a validated nomogram.
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
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: Yoga Exercise
Ashtanga yoga consisting of repeated sequences of the sun salutation within the 40 minute exercise period will be used as the yoga intervention. Intensity will be controlled through the rate of progression through the Surya Namaskar beginning at a low speed and increasing the rate of movement over the 12 week period. This group will attend exercise sessions under the supervision of a Certified Yoga Instructor. The intensity of yoga will be tracked through heart rate monitors worn by participants. By using a form of yoga that is more intense in its activity and more rapid in posture changes this form of yoga as it is the most likely type to illicit changes in VAT and CVD risk factors.
Behavioral: Yoga exercise
Yoga based on Ashtanga poses.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01766453
|Contact: Iris A Lesser, MSc||778 782 firstname.lastname@example.org|
|Contact: Scott A Lear, PhD||778 782 7916||sLear@providencehealth.bc.ca|
|Canada, British Columbia|
|Simon Fraser University||Not yet recruiting|
|Vancouver, British Columbia, Canada, V6B5K3|
|Contact: Iris A Lesser, MSc email@example.com|
|Principal Investigator: Scott A Lear, PhD|
|Principal Investigator:||Scott A Lear, PhD||Simon Fraser University|