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:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-25 @ 1:44 AM
NCT ID:
NCT04099394
Eligibility Criteria:
Inclusion criteria:
* Age 65 years or older
* Community-dwelling
* Physician diagnosis of knee OA
* Knee pain that occurs almost daily for at least the past 3 months
* Knee pain-related difficulty with walking or climbing stairs
* Stiffness in the knee for \<30 min/day in the morning
* Crepitus in the knee
Exclusion criteria:
* Non-English speaking
* Cognitive impairment (Mini-Cog score ≤3)
* Unable or unwilling to give informed consent or accept randomization in either study group
* Unwilling to wear a thigh-mounted accelerometer for 1 week
* Significant, non-corrected visual or hearing impairment
* Plans to move out of the area in the next 12 months
* Plans to have knee, hip, or any other major surgery (including joint replacement) in the next 12 months
* Unable to walk a quarter of a mile independently (use of a straight cane is acceptable)
* Prior participation in cognitive-behavioral therapy or counseling for pain
* Exercises regularly (≥20 minutes/week of walking, hiking, dancing, or strength training, or participate in water exercise)
* Temporary exclusion: Any of the following in the past 6 months: cancer requiring treatment (except for non-melanoma skin cancer), heart attack or failure, stroke, hip fracture, hip/knee replacement, spinal surgery, heart surgery, deep vein thrombosis, or pulmonary embolus
* Temporary exclusion: Hospitalization in the past month
* Temporary exclusion: Currently undergoing physical therapy or rehabilitation treatment for knee OA or impairments in mobility function
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT04099394
Study Brief:
Protocol Section:
NCT04099394