Home-Based Exercise and Weight Control Program for Pain Control in Overweight Elderly With Osteoarthritis of the Knee
1 other identifier
interventional
110
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2002
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2002
CompletedFirst Submitted
Initial submission to the registry
August 2, 2005
CompletedFirst Posted
Study publicly available on registry
August 4, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedResults Posted
Study results publicly available
January 1, 2015
CompletedJanuary 1, 2015
December 1, 2014
5.3 years
August 2, 2005
December 2, 2014
December 30, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
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
Secondary Outcomes (2)
Walking Distance
Between Base-line and 24 weeks
Stair Total (Climb, Descend)
Between Base-line and 24 Weeks
Study Arms (4)
Arm 1
ACTIVE COMPARATORGroup assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC).
Arm 2
ACTIVE COMPARATORGroup assigned to a Weight Control Nutritional Program (WC).
Arm 3
ACTIVE COMPARATORGroup assigned to a home-based exercise program (Ex).
Arm 4
NO INTERVENTIONUsual care and non- specific health information (C).
Interventions
a week of food diary and information about dietary fat intake and proper proportions of vegetables.
24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Edward Hines, Jr. VA Hospital
Hines, Illinois, 60141-3030, United States
Related 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. doi: 10.1682/jrrd.2007.04.0053.
PMID: 18712641RESULTWolf 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.
PMID: 20665344RESULTPossley 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.
PMID: 20437315RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Due to the small number of females, the results may not be generalizable to females. Limitations include requirement of having good upper body strength, shoulder range, hand eye coordination, and an investment of purchasing poles of $30 per pair.
Results Point of Contact
- Title
- Elly Budiman-Mak, MS MPH MD
- Organization
- Edward Hines, Jr. VA Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Elly Budiman-Mak, MS MPH MD
Edward Hines Jr. VA Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2005
First Posted
August 4, 2005
Study Start
October 1, 2002
Primary Completion
February 1, 2008
Study Completion
December 1, 2008
Last Updated
January 1, 2015
Results First Posted
January 1, 2015
Record last verified: 2014-12