NCT00955071

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Sep 2009

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 7, 2009

Completed
25 days until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

August 2, 2013

Status Verified

August 1, 2013

Enrollment Period

3.7 years

First QC Date

August 4, 2009

Last Update Submit

August 1, 2013

Conditions

ObesityMetabolic SyndromeCardiovascular Disease

Keywords

exercisephysical activitydietmetabolic riskvisceral fatInsulin Resistance

Outcome Measures

Primary Outcomes (2)

  • waist circumference

    6 months

  • 2-hour glucose

    6 months

Study Arms (4)

Control

NO INTERVENTION

Exercise: LVLI

ACTIVE COMPARATOR

low volume, low intensity

Other: Exercise: LVLI

Exercise: HVLI

ACTIVE COMPARATOR

high volume, low intensity

Other: Exercise: HVLI

Exercise: LVHI

ACTIVE COMPARATOR

low volume, high intensity

Other: Exercise: LVHI

Interventions

Exercise: LVLIOTHER

low volume, low intensity

Exercise: LVLI
Exercise: HVLIOTHER

high volume, low intensity

Exercise: HVLI
Exercise: LVHIOTHER

low volume, high intensity

Exercise: LVHI

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Kinesiology and Health Studies, Queen's University

Kingston, Ontario, K7L 3N6, Canada

Location

Related Publications (3)

  • 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.

    PMID: 30261125DERIVED

  • 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.

    PMID: 25732273DERIVED

  • 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.

    PMID: 23123790DERIVED

MeSH Terms

Conditions

ObesityMetabolic SyndromeCardiovascular DiseasesMotor ActivityInsulin Resistance

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesBehavior

Study Officials

  • Robert Ross, PhD

    Queen's University

    PRINCIPAL INVESTIGATOR

  • Robert Hudson, MD,PhD

    Queen's University

    PRINCIPAL INVESTIGATOR

  • Miu Lam, PhD

    Queen's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

August 4, 2009

First Posted

August 7, 2009

Study Start

September 1, 2009

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

August 2, 2013

Record last verified: 2013-08

Locations

CA(1)