Collaborative Lifestyle Intervention Program in Knee Osteoarthritis Patients

Osteoarthritis Clinical Trial

— CLIP-OA  

Official title:

The Collaborative Lifestyle Intervention Program in Knee Osteoarthritis Patients: CLIP-OA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02835326
• Other study ID #: 2015H0394
• Secondary ID: R01AG050725
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: April 2022

Study information

• Verified date: October 2022
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 227
• Est. completion date: April 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Behavioral:
• Exercise and Dietary Weight Loss
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.
• Walk with Ease
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.

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Ohio State University	National Institute on Aging (NIA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	baseline up to 2 years
Secondary	Anthropometric Battery	Body weight and height are used to calculate Body Mass Index (BMI). Body composition will be assessed using DEXA scans.	baseline up to 2 years
Secondary	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.	baseline up to 2 years
Secondary	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	baseline up to two years
Secondary	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	baseline up to two years
Secondary	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.	baseline up to two years
Secondary	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.	baseline up to two years
Secondary	Change in physical activity	Physical activity will be assessed using the Community Healthy Activities Model Program For Seniors (CHAMPS) and Lifecorder EX Accelerometer	baseline up to two years
Secondary	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).	baseline up to two years