Collaborative Lifestyle Intervention Program in Knee Osteoarthritis Patients (CLIP-OA)

The Ohio State University

Status: Completed

Conditions: Osteoarthritis

Treatments: Behavioral: Exercise and Dietary Weight Loss; Behavioral: Walk with Ease

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02835326

R01AG050725 (U.S. NIH Grant/Contract)

2015H0394

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 227 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Diagnosed with knee OA: physician documented radiographic tibiofemoral OA of one or both knees
• Overweight or Obese: BMI >25 and <40
• Knee Pain and Risk for Mobility Disability: self-reported difficulty walking ¼ mile, climbing stairs, lifting or carrying groceries, or performing other household activities due to knee pain
• Sedentary: sedentary lifestyle defined as currently participating < 20 minutes of weekly structured moderate intensity exercise occurring in bouts >10 min
• Health Status: all participants must be free of severe heart or systemic disease that would make moderate intensity exercise participation unsafe
• Age: > 50 years of age
• Stability of Residence: does not plan to move out of the Columbus metropolitan area for the duration of the study
• Consents: willing to give an informed consent and sign a HIPPA authorization form; (9) Physician Consent: treating rheumatologist and primary care physician provide medical consent for participation
• Agreeableness: willing to accept randomization and complete all assessment and intervention procedures

Exclusion criteria

• Health Status: any serious medical condition that precludes safe participation in an exercise program
• Study Staff Judgment: Inability to complete the study protocol, in the opinion of the study staff, due to frailty, illness, or other reasons

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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227 participants in 2 patient groups

Exercise and Dietary Weight Loss

Experimental group

Description:

For the first 6 months, participants will meet at a community center for 3 group-based sessions and 1 individual session each month. Sessions include a 45 minute exercise component and a 45 minute dietary weight loss component. Exercise will consist of progressive aerobic and strength training. The dietary component will focus on decreasing caloric intake, while being nutritionally safe. All diets will be monitored by a Registered Dietitian. During months 7-12, participants will meet for 1 group session and 1 individual session per month. The final 12-24 months, bimonthly phone calls are provided to the participants to aid in retention efforts.

Treatment:

Behavioral: Exercise and Dietary Weight Loss

Walk with Ease

Active Comparator group

Description:

The Arthritis Foundation's (AF) WWE is a self-management program for symptoms of arthritis (pain, fatigue, stiffness,etc.) through exercise. It is a 6 week program involving 3 sessions per week each lasting about 60 minutes. The WWE sessions are comprised of walking, stretching and strengthening exercises, and health education lectures. These group classes will be lead by an AF instructor. Each participant will complete 2 consecutive WWE classes for a total of 12 weeks in the program. During the final week of the program, participants will be trained and transitioin to the self-directed version of WWE for maintenance of exercise. To aid in retention efforts, phone contacts are provided to participants on a monthly basis from 4-12 months and bi-monthly from 12 to 24 months

Treatment:

Behavioral: Walk with Ease