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 @ 7:39 PM
Ignite Modification Date:
2025-12-24 @ 7:39 PM
NCT ID:
NCT06493903
Eligibility Criteria:
INCLUSION CRITERIA:
* Age≥50
* BMI ≤ 40 kg/m2
* Self-identify as Black (including African American)
* Knee pain ≥4/10 on a 11 numeric scale over the past week
* Scored 5 or more on either the Patient Health Questionnaire (PHQ-9) and/or the Generalized Anxiety Disorder 7-item Scale (GAD-7)
* Can speak and understand English at a sufficient level to understand the study procedures and informed consent
* Available for study duration
* Able to attend remote sessions
EXCLUSION CRITERIA
* Knee, hip or ankle replacement
* Intra-articular corticosteroid or hyaluronic acid knee injection within 3 months
* Knee surgery within past 6 months
* Currently receiving or received within 3-months any PT for knee OA
* Currently receiving or received within 3 months any mental health intervention (excluding pharmacologic treatments)
* Planning to initiate physical therapy for joint or low back pain in the next 3months
* Planning to initiate any mental health treatment (excluding pharmacologic treatments) in the next 1 month.
* Systemic inflammatory arthritis (e.g., rheumatoid arthritis)
* Neurologic conditions (e.g., stroke, Parkinson's disease, etc.)
* Contraindications to starting an exercise program.
* Suspected substance abuse
* Lack capacity to consent
* Pregnancy (self-report)
* Participation in another clinical trial for any joint or muscle pain
* Planning for a major surgery in the next 6 months
* Having high risk mental health symptoms (active suicidality, bipolar disorder, mania, psychosis, schizophrenia)
* Receiving chemotherapy or radiation therapy for cancer (except non-melanoma skin cancer)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT06493903
Study Brief:
Protocol Section:
NCT06493903