Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00126737
Status:
COMPLETED
Last Update Posted:
2015-01-01
First Post:
2005-08-02
Brief Title:
Home-Based Exercise and Weight Control Program for Pain Control in Overweight Elderly With Osteoarthritis of the Knee
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Home-Based Exercise and Weight Control Program for Pain Control in Overweight Elderly With Osteoarthritis of the Knee
Status:
COMPLETED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 US Arthritis is a leading chronic illness among older adults in the US 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 ExWC 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None