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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
Sponsor:
Information provided by (Responsible Party):
Scott Lear, Simon Fraser University

December 11, 2012
January 11, 2013
May 20, 2015
April 2013
November 2014   (Final data collection date for primary outcome measure)
Visceral adipose tissue [ Time Frame: 12 weeks ]
Visceral adipose tissue will be assessed with multi-slice computed tomography
Same as current
Complete list of historical versions of study NCT01766453 on ClinicalTrials.gov Archive Site
  • 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
  • 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 will be used to assess aerobic fitness using a validated nomogram.
Not Provided
Not Provided
 
South Asian Yoga and Exercise Trial
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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Obesity
  • Behavioral: Standard Exercise
    Aerobic exercise with a progressive increase in intensity over 12 weeks.
  • Behavioral: Bhangra dance exercise
    Bhangra Dance classes taught by an instructor.
  • 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.
    Intervention: Behavioral: Standard Exercise
  • 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.
    Intervention: Behavioral: Bhangra dance exercise
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
Same as current
November 2014
November 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
45 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01766453
SFU
No
Not Provided
Not Provided
Scott Lear, Simon Fraser University
Simon Fraser University
Not Provided
Principal Investigator: Scott A Lear, PhD Simon Fraser University
Simon Fraser University
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP