South Asian Yoga and Exercise Trial (SAYET)

May 18, 2015 updated by: Scott Lear, Simon Fraser University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6B5K3
        • Simon Fraser University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visceral adipose tissue
Time Frame: 12 weeks
Visceral adipose tissue will be assessed with multi-slice computed tomography
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiometabolic risk factors
Time Frame: 12 weeks
Blood will be drawn and assessed for lipids, glucose, insulin, CRP, adiponectin and ALT
12 weeks
Body Composition
Time Frame: 12 weeks
DEXA scans will be used to assess body fat distribution and lean body mass
12 weeks
Maximal Aerobic Fitness
Time Frame: 12 weeks
A Bruce protocol treadmill test with metabolic data will be used to assess aerobic fitness
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Simon Fraser University

Investigators

  • Principal Investigator: Scott A Lear, PhD, Simon Fraser University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

December 11, 2012

First Submitted That Met QC Criteria

January 9, 2013

First Posted (Estimate)

January 11, 2013

Study Record Updates

Last Update Posted (Estimate)

May 20, 2015

Last Update Submitted That Met QC Criteria

May 18, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SFU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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