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

NCT ID: NCT00955071

Last Updated: 2013-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2013-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Metabolic Syndrome Cardiovascular Disease

Keywords

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exercise physical activity diet metabolic risk visceral fat Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Exercise: LVLI

low volume, low intensity

Group Type ACTIVE_COMPARATOR

Exercise: LVLI

Intervention Type OTHER

low volume, low intensity

Exercise: HVLI

high volume, low intensity

Group Type ACTIVE_COMPARATOR

Exercise: HVLI

Intervention Type OTHER

high volume, low intensity

Exercise: LVHI

low volume, high intensity

Group Type ACTIVE_COMPARATOR

Exercise: LVHI

Intervention Type OTHER

low volume, high intensity

Interventions

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Exercise: LVLI

low volume, low intensity

Intervention Type OTHER

Exercise: HVLI

high volume, low intensity

Intervention Type OTHER

Exercise: LVHI

low volume, high intensity

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

Queen's University

OTHER

Sponsor Role lead

Responsible Party

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Bob Ross

Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Ross, PhD

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Robert Hudson, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Miu Lam, PhD

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

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School of Kinesiology and Health Studies, Queen's University

Kingston, Ontario, Canada

Site Status

Countries

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Canada

References

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Cowan TE, Brennan AM, Stotz PJ, Clarke J, Lamarche B, Ross R. Separate Effects of Exercise Amount and Intensity on Adipose Tissue and Skeletal Muscle Mass in Adults with Abdominal Obesity. Obesity (Silver Spring). 2018 Nov;26(11):1696-1703. doi: 10.1002/oby.22304. Epub 2018 Sep 27.

Reference Type DERIVED
PMID: 30261125 (View on PubMed)

Ross R, Hudson R, Stotz PJ, Lam M. Effects of exercise amount and intensity on abdominal obesity and glucose tolerance in obese adults: a randomized trial. Ann Intern Med. 2015 Mar 3;162(5):325-34. doi: 10.7326/M14-1189.

Reference Type DERIVED
PMID: 25732273 (View on PubMed)

Ross R, Hudson R, Day AG, Lam M. Dose-response effects of exercise on abdominal obesity and risk factors for cardiovascular disease in adults: study rationale, design and methods. Contemp Clin Trials. 2013 Jan;34(1):155-60. doi: 10.1016/j.cct.2012.10.010. Epub 2012 Nov 1.

Reference Type DERIVED
PMID: 23123790 (View on PubMed)

Other Identifiers

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Ross 2009

Identifier Type: -

Identifier Source: org_study_id