The Cherokee Study: Cherokee Health for Elderly Residents With Osteoarthritis of the Knee

NCT04946344 | Completed Results DMC

• 2 other identifiers: IRB00033618 - CherokeeU01AR068658
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

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.

Conditions

Osteoarthritis

Keywords

Knee Pain; Exercise; Diet; Weight Loss

Outcome Measures

Primary Outcomes (1)

• Western Ontario McMasters Universities Osteoarthritis Index (WOMAC) - Knee Pain

  Western Ontario McMasters Universities Osteoarthritis Index (WOMAC) pain subscale in overweight and obese adults with knee OA compared to an attention-control group - The pain index assesses participants' pain on the same scale, ranging from 0 (none) to 4 (extreme). The pain subscale consists of 5 items. Normalized values are reported. To calculate, the mean score of the individual items of is divided by 4 (the highest possible score for a single answer option). The mean of the observed items is then multiplied by 100 and subtracted from 100. Total scores can range from 0-100, with larger scores indicating greater pain.

  Month 3

Secondary Outcomes (3)

• Western Ontario McMasters Universities Osteoarthritis Index (WOMAC) - Function

  Month 3

• Health Related Quality of Life (SF-36)

  Month 3

• Distance Walked - Mobility (Six Minute Walk)

  Month 3

Other Outcomes (21)

• Physical Performance Battery (SPPB) - Balance

  Baseline and Month 3

• Physical Performance Battery (SPPB) - Walking Speed

  Baseline and Month 3

• Physical Performance Battery (SPPB) - Chair Rise

  Baseline and Month 3

Study Arms (2)

Diet & Exercise

EXPERIMENTAL

Participants will attend an exercise class 3 days/week for 3 months. The exercise program will consist of a 15-minute aerobic phase, a 20-minute strength training phase, a second 15-minute aerobic phase, and a 10 minute cool down phase. Participant's will also attend individual and group diet sessions. Each participant will be prescribed an individual walking prescription by the exercise leader, which will be adjusted accordingly, as each participant progresses throughout the 3 months. The exercise will be of moderate intensity. Alternate forms of aerobic exercise, such as but not limited to stationary bike, elliptical trainer, or treadmill walking, can be used in place of over-ground walking. This choice could be based on participant preference, the limitations of the exercise facility, or the participant's pain level.

Behavioral: Diet & Exercise

Attention Control

ACTIVE COMPARATOR

The attention control intervention will cover an 3 month period. There will be two face to face group meetings over the 3 months, with one meeting each at months 1 and 3; and during the other months (month 2) participants will receive a combination of text messages, emails, and phone calls based on continued monitoring of participant needs and delivered via their preferred mode of contact.

Behavioral: Attention Control

Interventions

Diet & Exercise BEHAVIORAL

Participants will attend exercise and diet classes.

Diet & Exercise

Attention Control BEHAVIORAL

Participants will attend healthy living classes and receive phone calls/emails/texts.

Attention Control

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wake Forest University: lead
• University of North Carolina, Chapel Hill: collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (2)

Ginger Welch Complex

Cherokee, North Carolina, 28719, United States

Location

Wake Forest University/Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Motor Activity; Weight Loss

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr. Stephen Messier
• Organization: Wake Forest University

messier@wfu.edu

336-758-3969

Study Officials

• Stephen P Messier, PhD

  Wake Forest University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 30 ambulatory, community-dwelling persons that meet the ACR clinical criteria for knee osteoarthritis

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: June 30, 2021
• Study Start: May 12, 2022
• Primary Completion: April 20, 2023
• Study Completion: April 20, 2023
• Last Updated: June 12, 2024
• Results First Posted: June 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available 6 months after study analysis has been completed.
• Access Criteria: Persons wishing to receive data must submit a formal request to the study team. Consultation with the leaders of tribe is required and approval must be given prior to data access.

Locations

US (2)