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

N/A

Waitlist Available

Led By Brian Focht, PhD

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a community-based diet and exercise program can help improve mobility in people with knee osteoarthritis better than the current standard program.

Eligible Conditions

Osteoarthritis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mobility Disability

Secondary study objectives

Anthropometric Battery

Change in physical activity

Cost effectiveness

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Exercise and Dietary Weight LossExperimental Treatment1 Intervention

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.

Group II: Walk with EaseActive Control1 Intervention

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Exercise and Dietary Weight Loss

2016

N/A

~230

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