South Asian Yoga and Exercise Trial (SAYET)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by Simon Fraser University
Sponsor:
Information provided by (Responsible Party):
Scott Lear, Simon Fraser University
ClinicalTrials.gov Identifier:
NCT01766453
First received: December 11, 2012
Last updated: January 9, 2013
Last verified: January 2013
  Purpose

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 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.


Condition Intervention
Obesity
Behavioral: Standard Exercise
Behavioral: Yoga exercise

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Simon Fraser University:

Primary Outcome Measures:
  • Visceral adipose tissue [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Visceral adipose tissue will be assessed with multi-slice computed tomography


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 75
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)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01766453

Contacts
Contact: Iris A Lesser, MSc 778 782 7748 iris.lesser@sfu.ca
Contact: Scott A Lear, PhD 778 782 7916 sLear@providencehealth.bc.ca

Locations
Canada, British Columbia
Simon Fraser University Not yet recruiting
Vancouver, British Columbia, Canada, V6B5K3
Contact: Iris A Lesser, MSc       iris.lesser@sfu.ca   
Principal Investigator: Scott A Lear, PhD         
Sponsors and Collaborators
Simon Fraser University
Investigators
Principal Investigator: Scott A Lear, PhD Simon Fraser University
  More Information

No publications provided

Responsible Party: Scott Lear, Professor, Simon Fraser University
ClinicalTrials.gov Identifier: NCT01766453     History of Changes
Other Study ID Numbers: SFU
Study First Received: December 11, 2012
Last Updated: January 9, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Simon Fraser University:
South Asian
Cardiovascular
Exercise
Obesity
Visceral Adipose Tissue

Additional relevant MeSH terms:
Cardiovascular Diseases
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 26, 2014