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

Primary Purpose

Chronic Diseases, Obesity, Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight Control Nutritional Program
Home-based exercise program
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Diseases focused on measuring Elderly, Exercise, lean body mass, muscle strength, Nutrition program, Pain control, stair climb, walking distance, weight loss

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Edward Hines, Jr. VA Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

No Intervention

Arm Label

Arm 1

Arm 2

Arm 3

Arm 4

Arm Description

Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC).

Group assigned to a Weight Control Nutritional Program (WC).

Group assigned to a home-based exercise program (Ex).

Usual care and non- specific health information (C).

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Walking Distance
Average distance walked in six minutes. The average change in distance walked (meters) 24 weeks post-baseline was measured.
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.

Full Information

First Posted
August 2, 2005
Last Updated
December 30, 2014
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00126737
Brief Title
Home-Based Exercise and Weight Control Program for Pain Control in Overweight Elderly With Osteoarthritis of the Knee
Official Title
Home-Based Exercise and Weight Control Program for Pain Control in Overweight Elderly With Osteoarthritis of the Knee
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Diseases, Obesity, Osteoarthritis, Pain
Keywords
Elderly, Exercise, lean body mass, muscle strength, Nutrition program, Pain control, stair climb, walking distance, weight loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Active Comparator
Arm Description
Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC).
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
Group assigned to a Weight Control Nutritional Program (WC).
Arm Title
Arm 3
Arm Type
Active Comparator
Arm Description
Group assigned to a home-based exercise program (Ex).
Arm Title
Arm 4
Arm Type
No Intervention
Arm Description
Usual care and non- specific health information (C).
Intervention Type
Other
Intervention Name(s)
Weight Control Nutritional Program
Other Intervention Name(s)
pole striding walking exercise
Intervention Description
a week of food diary and information about dietary fat intake and proper proportions of vegetables.
Intervention Type
Other
Intervention Name(s)
Home-based exercise program
Intervention Description
24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises.
Primary Outcome Measure Information:
Title
WOMAC Function
Description
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.
Time Frame
Between Base-line and 24 weeks
Title
Physical Scale SF-36v
Description
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.
Time Frame
Between Base-line and 24 weeks
Title
Mental Scale SF-36v
Description
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.
Time Frame
Between Base-line and 24 weeks
Secondary Outcome Measure Information:
Title
Walking Distance
Description
Average distance walked in six minutes. The average change in distance walked (meters) 24 weeks post-baseline was measured.
Time Frame
Between Base-line and 24 weeks
Title
Stair Total (Climb, Descend)
Description
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.
Time Frame
Between Base-line and 24 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elly Budiman-Mak, MS MPH MD
Organizational Affiliation
Edward Hines Jr. VA Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Edward Hines, Jr. VA Hospital
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141-3030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18712641
Citation
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.
Results Reference
result
PubMed Identifier
20665344
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. doi: 10.1682/jrrd.2009.08.0136.
Results Reference
result
PubMed Identifier
20437315
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. doi: 10.1682/jrrd.2009.03.0024.
Results Reference
result

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

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