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NCT02835326 | COMPLETED | Osteoarthritis

Collaborative Lifestyle Intervention Program in Knee Osteoarthritis Patients
Sponsor:

Ohio State University

Information provided by (Responsible Party):

Brian

Brief Summary:

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.

Condition or disease

Osteoarthritis

Intervention/treatment

Exercise and Dietary Weight Loss

Walk with Ease

Phase

NA

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 227 participants
Masking : SINGLE
Primary Purpose : SUPPORTIVE_CARE
Official Title : The Collaborative Lifestyle Intervention Program in Knee Osteoarthritis Patients: CLIP-OA
Actual Study Start Date : 2016-10
Estimated Primary Completion Date : 2022-04
Estimated Study Completion Date : 2022-04

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 50 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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
Collaborative Lifestyle Intervention Program in Knee Osteoarthritis Patients

Location Details

NCT02835326

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Locations

Not yet recruiting

United States, Ohio

The Ohio State University

Columbus, Ohio, United States, 43210