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Behavioral Intervention
Diet & Exercise for Osteoarthritis (Cherokee Trial)
N/A
Waitlist Available
Led By Stephen P Messier, PhD
Research Sponsored by Wake Forest University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 3
Awards & highlights
Cherokee Trial Summary
This trial will test a weight loss and exercise intervention to see if it reduces pain and improves other clinical outcomes in knee OA patients in a real-world setting.
Eligible Conditions
- Osteoarthritis
Cherokee Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 3
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Western Ontario McMasters Universities Osteoarthritis Index (WOMAC) - Change in Knee pain
Secondary outcome measures
Cost-effectiveness
Distance walked - Mobility (six minute walk)
Health Related Quality of Life (SF-36)
+1 moreOther outcome measures
(DHQ) Dietary History Questionnaire
Behavioral Risk Factor Surveillance System (BRFSS)
Center for Epidemiologic Studies Depression Scale
+17 moreCherokee Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Diet & ExerciseExperimental Treatment1 Intervention
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.
Group II: Attention ControlActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Diet & Exercise
2016
N/A
~1000
Find a Location
Who is running the clinical trial?
University of North Carolina, Chapel HillOTHER
1,504 Previous Clinical Trials
4,187,646 Total Patients Enrolled
24 Trials studying Osteoarthritis
1,909 Patients Enrolled for Osteoarthritis
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
483 Previous Clinical Trials
1,086,924 Total Patients Enrolled
50 Trials studying Osteoarthritis
46,965 Patients Enrolled for Osteoarthritis
Wake Forest UniversityLead Sponsor
189 Previous Clinical Trials
164,564 Total Patients Enrolled
4 Trials studying Osteoarthritis
2,884 Patients Enrolled for Osteoarthritis
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any remaining vacancies for this clinical testing protocol?
"Clinicaltrials.gov indicates that this clinical trial is currently searching for participants; the study was originally posted on May 12th 2022 and last amended on November 28th of the same year."
Answered by AI
How many participants are being recruited for this research?
"Affirmative. As per the information available from clinicaltrials.gov, this medical study is open to participants and was initiated on May 12th 2022 with a final edit made November 28th of that same year. The research team seeks 30 volunteers across two locations."
Answered by AI
Who else is applying?
What state do they live in?
Georgia
How old are they?
65+
What portion of applicants met pre-screening criteria?
Met criteria
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