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

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Bob Ross, Queen's University
ClinicalTrials.gov Identifier:
NCT00955071
First received: August 4, 2009
Last updated: August 1, 2013
Last verified: August 2013
  Purpose

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
Obesity
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
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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
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: NCT00955071

Locations
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)
Investigators
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 by Queen's University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bob Ross, Ph.D., Queen's University
ClinicalTrials.gov Identifier: NCT00955071     History of Changes
Other Study ID Numbers: Ross 2009
Study First Received: August 4, 2009
Last Updated: August 1, 2013
Health Authority: Canada: Health Canada

Keywords provided by Queen's University:
exercise
physical activity
diet
metabolic risk
visceral fat
Insulin Resistance

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

ClinicalTrials.gov processed this record on August 26, 2014