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: December 30, 2014
Last verified: December 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
Other: Home-based exercise 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:
  • WOMAC Function [ Time Frame: Between Base-line and 24 weeks ] [ Designated as safety issue: No ]
    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.

  • Physical Scale SF-36v [ Time Frame: Between Base-line and 24 weeks ] [ Designated as safety issue: No ]
    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.

  • Mental Scale SF-36v [ Time Frame: Between Base-line and 24 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Walking Distance [ Time Frame: Between Base-line and 24 weeks ] [ Designated as safety issue: No ]
    Average distance walked in six minutes. The average change in distance walked (meters) 24 weeks post-baseline was measured.

  • Stair Total (Climb, Descend) [ Time Frame: Between Base-line and 24 Weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 110
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
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 Name: 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 Name: 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).

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

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 American College of Rheumatology (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
Results First Received: December 2, 2014
Last Updated: December 30, 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
Arthritis
Disease Attributes
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 02, 2015