The Collaborative Lifestyle Intervention Program in Knee OsteoArthritis Patients (CLIP-OA) compares a novel community-based exercise and dietary weight loss program to the Arthritis Foundation's Walk with Ease intervention on improved mobility in knee osteoarthritis (OA) patients.
Knee OA is a chronic, progressive, degenerative disease that affects over 20 million Americans, and is cited as the primary cause for activity restriction and physical disability in older adults. The joint damage and symptoms (i.e., pain, stiffness, and fatigue) accompanying symptomatic knee OA result in activity restriction, muscle atrophy, reduced quality of life and difficulty in performance of functional tasks. Despite the well-established benefits of the Arthritis Foundation's (AF) exercise programs, recent evidence suggests that lifestyle interventions combining Exercise and Dietary Weight Loss (EX+DWL) results in superior improvements in key clinical outcomes in older, overweight or obese knee OA patients. Primary Aim: To compare the effects of a novel community-based EX+DWL program to AF's Walk with Ease (WWE) EX intervention on improved mobility in knee osteoarthritis (OA) patients. Secondary Aim: To compare the cost effectiveness and effects of the EX+DWL and WWE interventions on weight loss, pain, and quality of life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
227
The EX+DWL intervention consists of group and individual exercise sessions, as well as, nutritional and dietary counseling. Bimonthly phone calls are made in the final year of the study to aid in maintenance of the program.
The WWE 6 week program consists of health education lectures on arthritis self-management, a walking exercise portion, and at- home strength exercises. Participants will complete two consecutive WWE programs. Monthly and bimonthly phone calls are made to participants in months 4-12 and 12-24, respectively, to aid in maintenance of the program.
The Ohio State University
Columbus, Ohio, United States
Mobility Disability
This will be assessed using the 400 meter walk test (400MWT), which is the time to complete 400m as quickly as possible (without running)
Time frame: baseline up to 2 years
Anthropometric Battery
Body weight and height are used to calculate Body Mass Index (BMI). Body composition will be assessed using DEXA scans.
Time frame: baseline up to 2 years
Functional Battery and Limitations
Stair-climb time (SCT) is a functional performance measure that involves ascending and descending a flight of 5 stairs as quickly as possible. Limitations will be assessed using the Pepper Assessment Tool for Disability.
Time frame: baseline up to 2 years
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Scale of 0 (none) to 4 (extreme) indicating the amount of difficulty they have experienced performing basic physical function tasks in the past 48 hours due to knee OA. The physical function subscale consists of 17 items that will be summed to produce a physical function score. Higher scores indicating poorer function
Time frame: baseline up to two years
Rand Medical Outcomes Study 36-item Short Form Health Survey (SF-36)
Health related quality of life survey consisting of mental and physical health with subscales of physical functioning, mental health, role-physical, role-emotional, bodily pain, general health, vitality, and social functioning
Time frame: baseline up to two years
Dietary intake
Dietary intake will be assessed by a registered dietician using the Daily food record measure. One weekend and 2 weekdays will be assessed.
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Time frame: baseline up to two years
Social Cognitive Process Measures
Physical activity barriers self-efficacy scale, Satisfaction with function and appearance scale, Multiple exercise self-regulatory self-efficacy scale, the weight efficacy lifestyle questionnaire (WEL), goal commitment and goal difficulty, arthritis self-efficacy, and pain acceptance.
Time frame: baseline up to two years
Change in physical activity
Physical activity will be assessed using the Community Healthy Activities Model Program For Seniors (CHAMPS) and Lifecorder EX Accelerometer
Time frame: baseline up to two years
Cost effectiveness
The cost-effectiveness of the EX+DWL intervention compared to the WWE \[program will be calculated as the ratio of additional cost per participant per increment of effectiveness. Effectiveness is based on improvement in the 400 MWT and the Quality of Well-being Scale- Self Administered (to calculate the Quality Adjusted Life Years).
Time frame: baseline up to two years