Clinical Trials Directory

Trials / Completed

CompletedNCT00126737

Home-Based Exercise and Weight Control Program for Pain Control in Overweight Elderly With Osteoarthritis of the Knee

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
110 (actual)
Sponsor
US Department of Veterans Affairs · Federal
Sex
All
Age
50 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to determine whether a home-based exercise and weight control program applied to elderly overweight individuals with painful osteoarthritis of the knee, would result in pain reduction.

Detailed description

Osteoarthritis (OA) is the most common chronic disease in the United States (U.S.). Arthritis is a leading chronic illness among older adults in the U.S. Approximately 40% of individuals above 60 yr of age have OA of the knee. The primary objective of the proposed study is to determine whether individuals who are overweight with OA of the knee and who complete a 24-week home-based exercise program combined with a weight control intervention program will report significantly less pain (as measured by the WOMAC) than volunteers who participate in home-based exercise (Ex) only, weight control intervention (WC) only, or standard clinical care (C). The secondary objectives of the proposed research are to determine whether overweight individuals with OA of the knee who complete the Ex+WC program, when compared to subjects who are randomly assigned to a E, WC or C groups, demonstrate significant improvement in the following health risk profile variables: (a) improved physical function (measured by the Functional Performance Inventory), (b) improved capacity to perform stair climbing and descending, (c) improved strength, (d) increased lean body mass, (e) increase in physical activity at home (measured by pedometer step count). The proposed clinical trial will utilize a prospective, randomized two by two factorial design. Descriptive and ancova statistical method will be applied for data analyses.

Conditions

Interventions

TypeNameDescription
OTHERWeight Control Nutritional Programa week of food diary and information about dietary fat intake and proper proportions of vegetables.
OTHERHome-based exercise program24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises.

Timeline

Start date
2002-10-01
Primary completion
2008-02-01
Completion
2008-12-01
First posted
2005-08-04
Last updated
2015-01-01
Results posted
2015-01-01

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00126737. Inclusion in this directory is not an endorsement.