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Completed

NCT Number: NCT01766453

South Asian Yoga and Exercise Trial

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.

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Key information

Age range

45 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Simon Fraser University

Vancouver, British Columbia, V6B5K3, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Exercise

Behavioral

Aerobic exercise with a progressive increase in intensity over 12 weeks.

Bhangra dance exercise

Behavioral

Bhangra Dance classes taught by an instructor.

Primary outcomes

  1. Visceral adipose tissue

    Time frame: 12 weeks

    Visceral adipose tissue will be assessed with multi-slice computed tomography

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Simon Fraser University

Other

Registry information

Official study 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

Acronym: SAYET

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 11, 2013
Registry last updated
May 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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