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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00955071
Recruitment Status : Completed
First Posted : August 7, 2009
Last Update Posted : August 2, 2013
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Bob Ross, Queen's University

Brief Summary:

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 or disease Intervention/treatment Phase
Obesity Metabolic Syndrome Cardiovascular Disease Other: Exercise: LVLI Other: Exercise: HVLI Other: Exercise: LVHI Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Dose-response Effects of Exercise on Abdominal Obesity and Risk Factors for CVD in Men and Women.
Study Start Date : September 2009
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Arm Intervention/treatment
No Intervention: Control
Active Comparator: Exercise: LVLI
low volume, low intensity
Other: Exercise: LVLI
low volume, low intensity
Active Comparator: Exercise: HVLI
high volume, low intensity
Other: Exercise: HVLI
high volume, low intensity
Active Comparator: Exercise: LVHI
low volume, high intensity
Other: Exercise: LVHI
low volume, high intensity

Primary Outcome Measures :
  1. waist circumference [ Time Frame: 6 months ]
  2. 2-hour glucose [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00955071

Canada, Ontario
School of Kinesiology and Health Studies, Queen's University
Kingston, Ontario, Canada, K7L 3N6
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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bob Ross, Ph.D., Queen's University Identifier: NCT00955071     History of Changes
Other Study ID Numbers: Ross 2009
First Posted: August 7, 2009    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: August 2013

Keywords provided by Bob Ross, Queen's University:
physical activity
metabolic risk
visceral fat
Insulin Resistance

Additional relevant MeSH terms:
Cardiovascular Diseases
Metabolic Syndrome X
Obesity, Abdominal
Nutrition Disorders
Body Weight
Signs and Symptoms
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases