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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2016 by Ohio State University
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Brian Focht, Ohio State University
ClinicalTrials.gov Identifier:
NCT02835326
First received: July 13, 2016
Last updated: NA
Last verified: July 2016
History: No changes posted
  Purpose
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 Intervention
Osteoarthritis
Behavioral: Exercise and Dietary Weight Loss
Behavioral: Walk with Ease

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: The Collaborative Lifestyle Intervention Program in Knee Osteoarthritis Patients: CLIP-OA

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Mobility Disability [ Time Frame: baseline up to 2 years ] [ Designated as safety issue: No ]
    This will be assessed using the 400 meter walk test (400MWT), which is the time to complete 400m as quickly as possible (without running)


Secondary Outcome Measures:
  • Anthropometric Battery [ Time Frame: baseline up to 2 years ] [ Designated as safety issue: No ]
    Body weight and height are used to calculate Body Mass Index (BMI). Body composition will be assessed using DEXA scans.

  • Functional Battery and Limitations [ Time Frame: baseline up to 2 years ] [ Designated as safety issue: No ]
    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.

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: baseline up to two years ] [ Designated as safety issue: No ]
    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

  • Rand Medical Outcomes Study 36-item Short Form Health Survey (SF-36) [ Time Frame: baseline up to two years ] [ Designated as safety issue: No ]
    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

  • Dietary intake [ Time Frame: baseline up to two years ] [ Designated as safety issue: No ]
    Dietary intake will be assessed by a registered dietician using the Daily food record measure. One weekend and 2 weekdays will be assessed.

  • Social Cognitive Process Measures [ Time Frame: baseline up to two years ] [ Designated as safety issue: No ]
    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.

  • Change in physical activity [ Time Frame: baseline up to two years ] [ Designated as safety issue: No ]
    Physical activity will be assessed using the Community Healthy Activities Model Program For Seniors (CHAMPS) and Lifecorder EX Accelerometer

  • Cost effectiveness [ Time Frame: baseline up to two years ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 224
Study Start Date: September 2016
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise and Dietary Weight Loss
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.
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.
Active Comparator: Walk with Ease
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
Behavioral: 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.

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

Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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: > 60 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02835326

Contacts
Contact: Jessica Dicke, MS dicke.35@osu.edu
Contact: Brian Focht, PhD 614-292-2165 focht.10@osu.edu

Locations
United States, Ohio
The Ohio State University Not yet recruiting
Columbus, Ohio, United States, 43210
Contact: Jessica Dicke, MS       dicke.35@osu.edu   
Sponsors and Collaborators
Ohio State University
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Investigators
Principal Investigator: Brian Focht, PhD Ohio State University
  More Information

Responsible Party: Brian Focht, Associate Chair, Associate Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT02835326     History of Changes
Other Study ID Numbers: 2015H0394  R01AG050725 
Study First Received: July 13, 2016
Last Updated: July 13, 2016
Health Authority: United States: Federal Government

Keywords provided by Ohio State University:
Older Adults
Weight Loss
Exercise
Knee pain

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 28, 2016