NCT00520858

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
145

participants targeted

Target at P75+ for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2007

Completed
Last Updated

April 22, 2008

Status Verified

April 1, 2008

First QC Date

August 24, 2007

Last Update Submit

April 21, 2008

Conditions

Outcome Measures

Primary Outcomes (1)

  • Abdominal obesity

    6 months

Secondary Outcomes (1)

  • Insulin Resistance

    6 Months

Study Arms (4)

C

NO INTERVENTION

RE

ACTIVE COMPARATOR

Resistance Exercise

Other: Resistance Exercise (RE)

AE

ACTIVE COMPARATOR

Aerobic Exercise

Other: Aerobic Exercise (AE)

RAE

ACTIVE COMPARATOR

Resistance and Aerobic

Other: Resistance and Aerobic Exercise (RAE)

Interventions

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Smokers and diabetics.
  • Women taking hormone replacement therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen's University

Kingston, Ontario, K7L 3N6, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Obesity, Abdominal

Interventions

Resistance TrainingExercise

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Robert Ross

    Queen's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 24, 2007

First Posted

August 27, 2007

Study Start

September 1, 2003

Last Updated

April 22, 2008

Record last verified: 2008-04

Locations