Effects of Exercise on Abdominal Obesity and Risk Factors for Cardiovascular Disease

Effects of Exercise on Abdominal Obesity and Risk Factors for Cardiovascular Disease
This study is currently recruiting participants.
Verified on June 2011 by Queen’s University

First Received on August 4, 2009.  
Last Updated on June 13, 2011  
History of Changes
Sponsor: Queen’s University
Collaborator: Canadian Institutes of Health Research (CIHR)
Information provided by: Queen’s University
ClinicalTrials.gov Identifier: NCT00955071

The investigators will randomize abdominally obese men and women at increased health risk to one of the following 4 conditions: 1) No-exercise, wait list controls (C), 2) Low volume, low intensity exercise (LVLI), 3) High volume, low intensity exercise (HVLI), 4) Low volume, high intensity exercise (LVHI).

The primary aim of the trial is to determine the effects of varying exercise dose (energy expenditure, kcal) or intensity (relative to VO2max (cardiorespiratory fitness)) on waist circumference and glucose tolerance. The investigators will test the following hypotheses: 1) That the reduction in waist circumference and improvement in glucose tolerance in response to all treatments will be greater than controls. 2) That reduction in waist circumference and improvement in glucose tolerance in HVLI and LVHI will be greater than LVLI. 3) That hypotheses 1 and 2 are true independent of gender.

Condition Intervention
Metabolic Syndrome
Cardiovascular Disease
Other: Exercise: LVLI
Other: Exercise: HVLI
Other: Exercise: LVHI

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Dose-response Effects of Exercise on Abdominal Obesity and Risk Factors for CVD in Men and Women.

Resource links provided by NLM:

Further study details as provided by Queen’s University:

Primary Outcome Measures:

  • waist circumference [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 2-hour glucose [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 320
Study Start Date: September 2009
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)


Assigned Interventions
Control: No Intervention
Exercise: LVLI: Active Comparator

low volume, low intensity
Intervention: Other: Exercise: LVLI
Other: Exercise: LVLI

low volume, low intensity
Exercise: HVLI: Active Comparator

high volume, low intensity
Intervention: Other: Exercise: HVLI
Other: Exercise: HVLI

high volume, low intensity
Exercise: LVHI: Active Comparator

low volume, high intensity
Intervention: Other: Exercise: LVHI
Other: Exercise: LVHI

low volume, high intensity


Ages Eligible for Study:   35 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Men and women between 40 and 60 years of age. The lower age range for men and women is selected to help ensure recruitment of a sample with metabolic syndrome as prevalence of metabolic syndrome is significantly related to age. The selection of 60 years for the upper age range reflects concerns we have randomizing older adults to the high intensity exercise group wherein exercise at 75-80% of maximum may be difficult to achieve, and likely to be associated with increase orthopaedic injury and thus, poor compliance. We also considered lowering the lower age range from 40 to 35 years, but decided against doing so to increase the cost-effectiveness of recruitment (e.g., ensure a higher yield of those with metabolic syndrome).
  • Abdominally obese (waist circumference greater than 88 and 102 cm for women and men respectively) and NCEP-ATPIII defined Metabolic Syndrome. Abdominal obesity for non-Caucasians will be determined using values suggested by the International Diabetes Federation.
  • Sedentary lifestyle (planned physical activity for the purpose of health one day per week or less).
  • Weight stable (± 2 kg) for 6 months prior to the beginning of the study.
  • BMI less than 40 kg/m2 (Because a lifestyle-based intervention alone for obesity reduction is ideal for persons with a BMI less than 40 kg/m2).

Exclusion Criteria:

  • Physical impairment which would make the intervention very difficult, or unsafe according to the patient’s physician including history of myocardial infarction, stroke, coronary bypass surgery or angioplasty in the last 6 months; peripheral artery disease, unstable angina or ischemia.
  • Diabetes.
  • Current smokers.
  • Alcohol consumption > 21 drinks per week.
  • Plans to move from the area.
  • Participating in another research study.
  • Clinically judged to be unsuitable for participation or adherence as determined by the participants physician.
  • Inability or unwillingness to provide informed consent.
  • For women, planned pregnancy in the next year.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955071

Contact: Robert Ross, PhD 613-533-6583 rossr@queensu.ca

Canada, Ontario
School of Kinesiology and Health Studies, Queen’s University Recruiting
Kingston, Ontario, Canada, K7L 3N6
Contact: Robert Ross, PhD     613-533-6583     rossr@queensu.ca    
Sponsors and Collaborators
Queen’s University
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Robert Ross, PhD Queen’s University
Principal Investigator: Robert Hudson, MD,PhD Queen’s University
Principal Investigator: Miu Lam, PhD Queen’s University
  More Information

No publications provided

Responsible Party: Dr. Robert Ross, Queen’s University
ClinicalTrials.gov Identifier: NCT00955071    
History of Changes
Other Study ID Numbers: Ross 2009
Study First Received: August 4, 2009
Last Updated: June 13, 2011
Health Authority: Canada: Health Canada

Keywords provided by Queen’s University:

physical activity
metabolic risk
visceral fat
Insulin Resistance

Additional relevant MeSH terms:

Cardiovascular Diseases
Obesity, Abdominal
Metabolic Syndrome X
Nutrition Disorders
Body Weight
Signs and Symptoms
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 28, 2011

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