Clinical trial NCT00126737: Home-Based Exercise and Weight Control Program for Pain Control in Overweight Elderly With Osteoarthritis of the Knee
Official title: Home-Based Exercise and Weight Control Program for Pain Control in Overweight Elderly With Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Diseases
Obesity
Osteoarthritis
Pain
Keywords: Elderly
Exercise
lean body mass
muscle strength
Nutrition program
Pain control
stair climb
walking distance
weight loss
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-08-04
Enrollment: 110
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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 (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.

Eligibility criteria: Inclusion Criteria:

* Male \& female 50 years old
* Diagnosis of osteoarthritis by American College of Rheumatology criteria
* Knee radiographs of Kellgren and Lawrence grade 2-4
* American Arthritis Association functional class 1-3
* Body mass index of 27

Exclusion Criteria:

* Knee arthritis which did not meet American College of Rheumatology (ACR) OA criteria
* Unable to engage in exercise or follow instruction
* Limited shoulder range of motion

Primary outcomes:
measure: WOMAC Function
timeFrame: Between Base-line and 24 weeks
measure: Physical Scale SF-36v
timeFrame: Between Base-line and 24 weeks
measure: Mental Scale SF-36v
timeFrame: Between Base-line and 24 weeks
Secondary outcomes:
measure: Walking Distance
timeFrame: Between Base-line and 24 weeks
measure: Stair Total (Climb, Descend)
timeFrame: Between Base-line and 24 Weeks
Other outcomes:
Locations:
city: Hines
country: United States
facility: Edward Hines, Jr. VA Hospital
state: Illinois
Study officials:
affiliation: Edward Hines Jr. VA Hospital
name: Elly Budiman-Mak, MS MPH MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Collins E, O'Connell S, Jelinek C, Miskevics S, Budiman-Mak E. Evaluation of psychometric properties of Walking Impairment Questionnaire in overweight patients with osteoarthritis of knee. J Rehabil Res Dev. 2008;45(4):559-66. doi: 10.1682/jrrd.2007.04.0053.
citation: Wolf S, Foley S, Budiman-Mak E, Moritz T, O'Connell S, Jelinek C, Collins EG. Predictors of weight loss in overweight veterans with knee osteoarthritis who participated in a clinical trial. J Rehabil Res Dev. 2010;47(3):171-81. doi: 10.1682/jrrd.2009.08.0136.
citation: Possley D, Budiman-Mak E, O'Connell S, Jelinek C, Collins EG. Relationship between depression and functional measures in overweight and obese persons with osteoarthritis of the knee. J Rehabil Res Dev. 2009;46(9):1091-8. doi: 10.1682/jrrd.2009.03.0024.