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

December 30, 2014 updated by: US Department of Veterans Affairs
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Hines, Illinois, United States, 60141-3030
        • Edward Hines, Jr. VA Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 1
Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC).
Other: Weight Control Nutritional Program
a week of food diary and information about dietary fat intake and proper proportions of vegetables.
Other Names:
  • pole striding walking exercise
Other: Home-based exercise program
24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises.
Active Comparator: Arm 2
Group assigned to a Weight Control Nutritional Program (WC).
Other: Weight Control Nutritional Program
a week of food diary and information about dietary fat intake and proper proportions of vegetables.
Other Names:
  • pole striding walking exercise
Active Comparator: Arm 3
Group assigned to a home-based exercise program (Ex).
Other: Home-based exercise program
24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises.
No Intervention: Arm 4
Usual care and non- specific health information (C).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WOMAC Function
Time Frame: Between Base-line and 24 weeks
Western Ontario and McMaster University Osteoarthritis Index (WOMAC) is used to measure pain, function, and stiffness in patients with OA of the knee. At 24 weeks post-baseline, the average change in score was measured. We used the Function Scale only for this study. The Function Scale has 17 items, the responses are in Likert scale; namely 0=No difficulty, 1=Slight, 2=Moderate, 3= Very, 4=Extremely. The total score ranges from 0 to 68, a higher score means worse functioning. A score of 68 indicates extremely difficult in functioning.
Between Base-line and 24 weeks
Physical Scale SF-36v
Time Frame: Between Base-line and 24 weeks
The Rand Short Form-36 (SF-36) was used to measure health related quality of life (i.e. physical health). The average change in score 24 weeks post-baseline was measured. Physical Health consists of 4 scales, Physical Function (10 items), Role Physical (4 items), Bodily Pain (2 items), General Health (5 items). The Physical Health component is a summary measure of scales, and the scores ranges from 0 to 100, a score of 50 is the normative average of general health. Lower scores correspond to worse physical health, higher scores correspond to better physical health.
Between Base-line and 24 weeks
Mental Scale SF-36v
Time Frame: Between Base-line and 24 weeks
The Rand Short Form-36 (SF-36) was used to measure health related quality of life (i.e. mental health). The average change in score 24 weeks post-baseline was measured. Mental Health component consisted of 4 scales; these are the scales: Vitality ( 4 items), Social functioning (2 items), Role Emotional (3 items), and Mental Health (5 items). The mental health summary measures is called the Mental health component of SF36v. It was used to measure health related quality of life (i.e. mental health). The total score ranged from 0 to 100, a score of 50 is the normative average for general mental health. Lower scores correspond to worse mental health status, higher scores correspond to better mental health status.
Between Base-line and 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Walking Distance
Time Frame: Between Base-line and 24 weeks
Average distance walked in six minutes. The average change in distance walked (meters) 24 weeks post-baseline was measured.
Between Base-line and 24 weeks
Stair Total (Climb, Descend)
Time Frame: Between Base-line and 24 Weeks
Total amount of stairs climbed and descended for three minutes. Subjects climbed four steps up and descended four steps down. The average change in total number of steps 24 weeks post-baseline was measured.
Between Base-line and 24 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Investigators

  • Principal Investigator: Elly Budiman-Mak, MS MPH MD, Edward Hines Jr. VA Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

August 2, 2005

First Submitted That Met QC Criteria

August 2, 2005

First Posted (Estimate)

August 4, 2005

Study Record Updates

Last Update Posted (Estimate)

January 1, 2015

Last Update Submitted That Met QC Criteria

December 30, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E2920-R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe