South Asian Yoga and Exercise Trial
SAYET
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
1 other identifier
interventional
75
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Apr 2013
1 active site
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
December 11, 2012
CompletedFirst Posted
Study publicly available on registry
January 11, 2013
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedMay 20, 2015
May 1, 2015
1.6 years
December 11, 2012
May 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visceral adipose tissue
Visceral adipose tissue will be assessed with multi-slice computed tomography
12 weeks
Secondary Outcomes (3)
Cardiometabolic risk factors
12 weeks
Body Composition
12 weeks
Maximal Aerobic Fitness
12 weeks
Study Arms (3)
Non exercise control
NO INTERVENTIONNon exercise control will undergo baseline testing and follow up testing but will not participate in an exercise intervention.
Standard Exercise
EXPERIMENTALThe 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.
Bhangra Dance Exercise
EXPERIMENTALBhangra 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.
Interventions
Aerobic exercise with a progressive increase in intensity over 12 weeks.
Bhangra Dance classes taught by an instructor.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Simon Fraser University
Vancouver, British Columbia, V6B5K3, Canada
Related Publications (1)
Lesser IA, Singer J, Hoogbruin A, Mackey DC, Katzmarzyk PT, Sohal P, Leipsic J, Lear SA. Effectiveness of Exercise on Visceral Adipose Tissue in Older South Asian Women. Med Sci Sports Exerc. 2016 Jul;48(7):1371-8. doi: 10.1249/MSS.0000000000000906.
PMID: 26909531DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Scott A Lear, PhD
Simon Fraser University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 11, 2012
First Posted
January 11, 2013
Study Start
April 1, 2013
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
May 20, 2015
Record last verified: 2015-05