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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00126737
First received: August 2, 2005
Last updated: September 10, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Chronic Diseases
Obesity
Osteoarthritis
Pain
Other: Weight Control Nutritional Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Home-Based Exercise and Weight Control Program for Pain Control in Overweight Elderly With Osteoarthritis of the Knee

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • pain control [ Time Frame: 6/30/2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • physical functioning [ Time Frame: 6/30/2009 ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: October 2002
Study Completion Date: December 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
weight control only, weight control and exercise, exercise only
Other: Weight Control Nutritional Program
a week of food diary and information about dietary fat intake and proper proportions of vegetable
Other Name: pole striding walking exercise
No Intervention: Arm 2
usual care and non- specific health information

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 Manova statistical method will be applied for data analyses.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 ACR OA criteria
  • Unable to engage in exercise or follow instruction
  • Limited shoulder range of motion
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00126737

Locations
United States, Illinois
Edward Hines, Jr. VA Hospital
Hines, Illinois, United States, 60141-3030
Sponsors and Collaborators
Investigators
Principal Investigator: Elly Budiman-Mak, MS MPH MD Edward Hines Jr. VA Hospital
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00126737     History of Changes
Other Study ID Numbers: E2920-R
Study First Received: August 2, 2005
Last Updated: September 10, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Elderly
Exercise
lean body mass
muscle strength
Nutrition program
Pain control
stair climb
walking distance
weight loss

Additional relevant MeSH terms:
Chronic Disease
Osteoarthritis
Osteoarthritis, Knee
Overweight
Arthritis
Body Weight
Disease Attributes
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes
Rheumatic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014