Effects of Exercise Modality on Abdominal Obesity and Health Risk Factors in Older Men and Women
Primary Purpose
Abdominal Obesity
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Resistance Exercise (RE)
Aerobic Exercise (AE)
Resistance and Aerobic Exercise (RAE)
Sponsored by
About this trial
This is an interventional treatment trial for Abdominal Obesity
Eligibility Criteria
Inclusion Criteria:
- Men and women between 65 and 80 years of age.
- Men and women are self-sufficient, sedentary, abdominally obese (BMI between 27 and 34.9 kg/m2; waist circumference greater than 88 cm in women and 102 cm in men), weight stable (± 2 kg) for 6 months prior to the beginning of the study, be non-smokers, and not diabetic.
- We will study elderly women who are not taking hormone replacement therapy to create a homogeneous population in whom the effect of exercise on the principal outcome variables can be evaluated with minimal confounding.
Exclusion Criteria:
- Smokers and diabetics.
- Women taking hormone replacement therapy.
Sites / Locations
- Queen's University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Active Comparator
Active Comparator
Active Comparator
Arm Label
C
RE
AE
RAE
Arm Description
Resistance Exercise
Aerobic Exercise
Resistance and Aerobic
Outcomes
Primary Outcome Measures
Abdominal obesity
Secondary Outcome Measures
Insulin Resistance
Full Information
NCT ID
NCT00520858
First Posted
August 24, 2007
Last Updated
April 21, 2008
Sponsor
Queen's University
Collaborators
Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT00520858
Brief Title
Effects of Exercise Modality on Abdominal Obesity and Health Risk Factors in Older Men and Women
Official Title
Effects of Exercise Modality on Abdominal Obesity and Health Risk Factors in Older Men and Women
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Queen's University
Collaborators
Canadian Institutes of Health Research (CIHR)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The prevalence of abdominal obesity in the elderly is increasing at alarming rates and thus, requires immediate attention. By comparison to younger adults, obesity reduction in the elderly presents a unique challenge and requires an innovative approach. We propose a novel approach to investigate the effects of different exercise types as independent treatment strategies for the reduction of obesity and related health risk factors in older men and women. We propose that exercise without caloric restriction will be associated with modest weight loss (3-5%), that in turn will be associated with significant reduction in abdominal obesity, insulin resistance, and a corresponding increase in skeletal muscle mass and function. We will determine the separate effects of resistance and aerobic exercise on these primary outcome variables, and, whether a treatment strategy that combines the two is optimal.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Enrollment
145 (Actual)
8. Arms, Groups, and Interventions
Arm Title
C
Arm Type
No Intervention
Arm Title
RE
Arm Type
Active Comparator
Arm Description
Resistance Exercise
Arm Title
AE
Arm Type
Active Comparator
Arm Description
Aerobic Exercise
Arm Title
RAE
Arm Type
Active Comparator
Arm Description
Resistance and Aerobic
Intervention Type
Other
Intervention Name(s)
Resistance Exercise (RE)
Intervention Type
Other
Intervention Name(s)
Aerobic Exercise (AE)
Intervention Type
Other
Intervention Name(s)
Resistance and Aerobic Exercise (RAE)
Primary Outcome Measure Information:
Title
Abdominal obesity
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Insulin Resistance
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Eligibility Criteria
Inclusion Criteria:
Men and women between 65 and 80 years of age.
Men and women are self-sufficient, sedentary, abdominally obese (BMI between 27 and 34.9 kg/m2; waist circumference greater than 88 cm in women and 102 cm in men), weight stable (± 2 kg) for 6 months prior to the beginning of the study, be non-smokers, and not diabetic.
We will study elderly women who are not taking hormone replacement therapy to create a homogeneous population in whom the effect of exercise on the principal outcome variables can be evaluated with minimal confounding.
Exclusion Criteria:
Smokers and diabetics.
Women taking hormone replacement therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Ross
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen's University
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3N6
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
19171808
Citation
Davidson LE, Hudson R, Kilpatrick K, Kuk JL, McMillan K, Janiszewski PM, Lee S, Lam M, Ross R. Effects of exercise modality on insulin resistance and functional limitation in older adults: a randomized controlled trial. Arch Intern Med. 2009 Jan 26;169(2):122-31. doi: 10.1001/archinternmed.2008.558.
Results Reference
derived
Learn more about this trial
Effects of Exercise Modality on Abdominal Obesity and Health Risk Factors in Older Men and Women
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