Clinical trial NCT04946344: The Cherokee Study: Cherokee Health for Elderly Residents With Osteoarthritis of the Knee
Official title: Cherokee Health for Elderly Residents With Osteoarthritis of the Knee in the Eastern Band
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Knee Pain
Exercise
Diet
Weight Loss
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2021-06-30
Enrollment: 16
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 30 ambulatory, community-dwelling persons that meet the ACR clinical criteria for knee osteoarthritis
Primary purpose: TREATMENT

Brief summary: This study aims to develop and demonstrate the effectiveness of a systematic, practical, cost-effective diet-induced weight loss and exercise intervention in Cherokee, North Caroling that will recruit American Indian participants; that can reduce pain and improve other clinical outcomes in knee OA patients. This pragmatic community-based trial will determine if the investigators previous findings translate to real-world settings and will address common concerns about barriers to effectiveness/ implementation.

Detailed description: Obesity is a modifiable risk factor for knee osteoarthritis (OA), and weight loss is an effective non-pharmacologic treatment to reduce pain. Recently, the investigators determined that under ideal, highly controlled circumstances, a diet-induced weight loss of 10% combined with exercise was significantly better at reducing pain than either intervention alone. Compared to the investigators previous longterm weight loss and exercise trials of knee OA, the diet-induced weight loss and exercise group was twice as effective at relieving pain. Whether the investigators results can be generalized to less rigorously monitored patient cohorts is unknown. Thus the challenge the investigators now face is to provide the practical means to implement this proven treatment in the community setting. This study aims to develop and demonstrate the effectiveness of a systematic, practical, cost-effective diet-induced weight loss and exercise intervention in both urban and rural communities that can reduce pain and improve other clinical outcomes in knee OA patients.

Participants will be 30 ambulatory, community-dwelling, overweight and obese men and women who meet the American College of Rheumatology clinical criteria for knee OA. The primary aim is to determine whether a pragmatic, community-based 3-month diet-induced weight loss and exercise intervention implemented in Cherokee, North Carolina significantly decreases knee pain in overweight and obese adults with knee OA relative to an attention control group. Secondary aims will determine whether this intervention improves self-reported function, health-related quality of life, and mobility. The investigators will also establish the cost-effectiveness of this pragmatic, community-based, multimodal diet-induced weight-loss and exercise program by conducting cost-effectiveness and budgetary impact analyses using data from the current trial in a validated computer-simulated model of knee OA.

Eligibility criteria: Inclusion Criteria:

* age ≥ 50
* Knee Pain plus American College of Radiology (ACR) Criteria for Knee Osteoarthritis
* BMI = 25 ≥ kg/m2

Exclusion Criteria:

* Significant co-morbid disease that would threaten safety or impair ability to participate in interventions or testing (Blindness; Type 1 diabetes; Severe coronary artery disease)
* Not sufficiently overweight or obese, BMI \< 27 kg/m2
* Not having knee pain
* Inability to finish 3-month study or unlikely to be compliant (Planning to leave area \> 1 month during the next 3 months; Unwilling to change eating or physical activity habits; Unwilling to discontinue pain medication use for 3 days prior to testing visit)
* Living \> 30 minutes from the intervention site
* Age, age \< 50
* Other conditions that may prohibit the effective delivery of the intervention (Unable to provide own transportation to exercise center; Unable to read or write)

Primary outcomes:
measure: Western Ontario McMasters Universities Osteoarthritis Index (WOMAC) - Knee Pain
timeFrame: Month 3
Secondary outcomes:
measure: Western Ontario McMasters Universities Osteoarthritis Index (WOMAC) - Function
timeFrame: Month 3
measure: Health Related Quality of Life (SF-36)
timeFrame: Month 3
measure: Distance Walked - Mobility (Six Minute Walk)
timeFrame: Month 3
Other outcomes:
measure: Physical Performance Battery (SPPB) - Balance
timeFrame: Baseline and Month 3
measure: Physical Performance Battery (SPPB) - Walking Speed
timeFrame: Baseline and Month 3
measure: Physical Performance Battery (SPPB) - Chair Rise
timeFrame: Baseline and Month 3
measure: Physical Performance Battery (SPPB) - Stair Activity
timeFrame: Baseline and Month 3
measure: EuroQol Quality of Life
timeFrame: Baseline and Month 3
measure: The Walking Efficacy for Duration Scale
timeFrame: Baseline and Month 3
measure: The Positive and Negative Affect (PANAS)
timeFrame: Baseline and Month 3
measure: The Gait Efficacy/Environmental Efficacy Scale
timeFrame: Baseline and Month 3
measure: Satisfaction With Life Scale
timeFrame: Baseline and Month 3
measure: The Weight Efficacy Lifestyle Questionnaire (WEL)
timeFrame: Baseline and Month 3
measure: The Perceived Stress Scale (PSS)
timeFrame: Baseline and Month 3
measure: The Adherence Self-efficacy Questionnaire
timeFrame: Baseline and Month 3
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Baseline and Month 3
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Baseline and Month 3
measure: Intermittent and Constant Osteoarthritis Pain (ICOAP)
timeFrame: Baseline and Month 3
measure: (DHQ) Dietary History Questionnaire
timeFrame: Baseline and Month 3
measure: Behavioral Risk Factor Surveillance System (BRFSS)
timeFrame: Baseline and Month 3
measure: The Physical Activity Scale for the Elderly (PASE)
timeFrame: Baseline and Month 3
measure: The Montreal Cognitive Assessment (MOCA)
timeFrame: Baseline and Month 3
measure: Center for Epidemiologic Studies Depression Scale
timeFrame: Baseline and Month 3
measure: Cost-effectiveness
timeFrame: Month 3
Locations:
city: Cherokee
country: United States
facility: Ginger Welch Complex
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University/Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University
name: Stephen P Messier, PhD
role: PRINCIPAL_INVESTIGATOR
References: