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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00126737
• Other study ID #: E2920-R
• Status: Completed
• Phase: N/A
• First received: August 2, 2005
• Last updated: December 30, 2014
• Start date: October 2002
• Est. completion date: December 2008

Study information

• Verified date: December 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Diseases
• Obesity
• Osteoarthritis
• Osteoarthritis, Knee
• Pain

Intervention

Other:
• Weight Control Nutritional Program
a week of food diary and information about dietary fat intake and proper proportions of vegetables.
• Home-based exercise program
24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises.

Locations

Country	Name	City	State
United States	Edward Hines, Jr. VA Hospital	Hines	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WOMAC Function	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	No
Primary	Physical Scale SF-36v	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	No
Primary	Mental Scale SF-36v	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	No
Secondary	Walking Distance	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	No
Secondary	Stair Total (Climb, Descend)	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	No