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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00520858
Other study ID # Ross2002
Secondary ID
Status Completed
Phase N/A
First received August 24, 2007
Last updated April 21, 2008
Start date September 2003

Study information

Verified date April 2008
Source Queen's University
Contact n/a
Is FDA regulated No
Health authority Canada: Canadian Institutes of Health Research
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 145
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 65 Years to 80 Years
Eligibility 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.

Study Design

Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Resistance Exercise (RE)

Aerobic Exercise (AE)

Resistance and Aerobic Exercise (RAE)


Locations

Country Name City State
Canada Queen's University Kingston Ontario

Sponsors (2)

Lead Sponsor Collaborator
Queen's University Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Abdominal obesity 6 months
Secondary Insulin Resistance 6 Months
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