Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2025-12-24 @ 5:35 PM
NCT ID:
NCT03281668
Eligibility Criteria:
Inclusion Criteria:
* between the ages of 40 and 75 years old
* body mass index of 18.5-50 kg/m²
* exhibits symptomatic knee OA, defined as a diagnosis of knee OA, as identified from University of North Carolina electronic medical records, and current knee symptoms in at least one knee, having a minimum score of 6 out of 20 on the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) pain subscale.
Exclusion Criteria:
* individuals diagnosed with a cardiovascular condition restricting exercise
* individuals currently meeting Department of Health and Human Services Guidelines for physical activity (≥ 150 minutes per week
* individuals currently doing HIIT
* individuals currently participating in physical therapy for knee OA
* individuals currently participating in another OA intervention study
* received a corticosteroid or hyaluronic acid intra-articular injection in the knee during the previous 3 weeks or scheduled for during the intervention
* diagnosis of gout in the knee
* diagnosis of rheumatoid arthritis
* diagnosis of fibromyalgia
* other systemic rheumatic disease
* severe dementia or other memory loss
* active diagnosis of psychosis or uncontrolled substance abuse disorder
* hospitalization for a stroke, heart attack, or heart failure, or had surgery for blocked arteries in the past 3 months
* total joint replacement knee surgery, other knee surgery, meniscus tear, or anterior cruciate ligament (ACL) tear in the past 6 months
* on a waiting list for total joint replacement
* severely impaired hearing or speech
* pregnant or planning to become pregnant while enrolled in the study
* inability to speak English
* serious or terminal illness as indicated by referral to hospice or palliative care
* nursing home residence
* inability to ride a stationary bike
* any other health problems that would prohibit safe participation in the study
* EKG results EKG suggesting the individual would not be able to safely participate in this study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT03281668
Study Brief:
Protocol Section:
NCT03281668