Clinical trial NCT02835326: Collaborative Lifestyle Intervention Program in Knee Osteoarthritis Patients
Official title: The Collaborative Lifestyle Intervention Program in Knee Osteoarthritis Patients: CLIP-OA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Older Adults
Weight Loss
Exercise
Knee pain
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Aging (NIA)
First posted: 2016-07-18
Enrollment: 227
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Mobility Disability
timeFrame: baseline up to 2 years
Secondary outcomes:
measure: Anthropometric Battery
timeFrame: baseline up to 2 years
measure: Functional Battery and Limitations
timeFrame: baseline up to 2 years
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: baseline up to two years
measure: Rand Medical Outcomes Study 36-item Short Form Health Survey (SF-36)
timeFrame: baseline up to two years
measure: Dietary intake
timeFrame: baseline up to two years
measure: Social Cognitive Process Measures
timeFrame: baseline up to two years
measure: Change in physical activity
timeFrame: baseline up to two years
measure: Cost effectiveness
timeFrame: baseline up to two years
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Brian Focht, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Focht BC, Rejeski WJ, Hackshaw K, Ambrosius WT, Groessl E, Chaplow ZL, DeScenza VR, Bowman J, Fairman CM, Nesbit B, Dispennette K, Zhang X, Fowler M, Haynam M, Hohn S. The Collaborative Lifestyle Intervention Program in Knee Osteoarthritis Patients (CLIP-OA) trial: Design and methods. Contemp Clin Trials. 2022 Apr;115:106730. doi: 10.1016/j.cct.2022.106730. Epub 2022 Mar 11.