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

Primary Purpose

Obesity, Metabolic Syndrome, Cardiovascular Disease

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Exercise: LVLI

Exercise: HVLI

Exercise: LVHI

About this trial

This is an interventional treatment trial for Obesity focused on measuring exercise, physical activity, diet, metabolic risk, visceral fat, Insulin Resistance

Eligibility Criteria

35 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

School of Kinesiology and Health Studies, Queen's University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

Arm Label

Control

Exercise: LVLI

Exercise: HVLI

Exercise: LVHI

Arm Description

low volume, low intensity

high volume, low intensity

low volume, high intensity

Outcomes

Primary Outcome Measures

waist circumference

2-hour glucose

Secondary Outcome Measures

Full Information

NCT ID

NCT00955071

First Posted

August 4, 2009

Last Updated

August 1, 2013

Sponsor

Queen's University

Collaborators

Canadian Institutes of Health Research (CIHR)

1. Study Identification

Unique Protocol Identification Number

NCT00955071

Brief Title

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

Official Title

Dose-response Effects of Exercise on Abdominal Obesity and Risk Factors for CVD in Men and Women.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Queen's University

Collaborators

Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Metabolic Syndrome, Cardiovascular Disease

Keywords

exercise, physical activity, diet, metabolic risk, visceral fat, Insulin Resistance

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Title

Exercise: LVLI

Arm Type

Active Comparator

Arm Description

low volume, low intensity

Arm Title

Exercise: HVLI

Arm Type

Active Comparator

Arm Description

high volume, low intensity

Arm Title

Exercise: LVHI

Arm Type

Active Comparator

Arm Description

low volume, high intensity

Intervention Type

Other

Intervention Name(s)

Exercise: LVLI

Intervention Description

low volume, low intensity

Intervention Type

Other

Intervention Name(s)

Exercise: HVLI

Intervention Description

high volume, low intensity

Intervention Type

Other

Intervention Name(s)

Exercise: LVHI

Intervention Description

low volume, high intensity

Primary Outcome Measure Information:

Title

waist circumference

Time Frame

6 months

Title

2-hour glucose

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert Ross, PhD

Organizational Affiliation

Queen's University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Robert Hudson, MD,PhD

Organizational Affiliation

Queen's University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Miu Lam, PhD

Organizational Affiliation

Queen's University

Official's Role

Principal Investigator

Facility Information:

Facility Name

School of Kinesiology and Health Studies, Queen's University

City

Kingston

State/Province

Ontario

ZIP/Postal Code

K7L 3N6

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

30261125

Citation

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.

Results Reference

derived

PubMed Identifier

25732273

Citation

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.

Results Reference

derived

PubMed Identifier

23123790

Citation

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.

Results Reference

derived

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

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