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 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT06462560
Eligibility Criteria:
Inclusion Criteria:
* 55-85 years of age
* Diagnosis of Osteoarthritis within the prior 6 months
* Symptomatic OA defined as self-report:
* Pain in the knee(s) on most days of the month
* Difficulty with at least one of the following because of knee pain:
* walking ¼ of a mile
* climbing stairs
* getting in and out of a car, bath, or bed
* rising from a chair
* or performing shopping, cleaning, or self-care activities
* Radiographic KL grade II-III (using Kellgren and Lawrence criteria) of one or both knees
* Physically able to participate in strength training - able to do one chair stand unassisted in order to test change in 30-second chair stand
* Ambulatory and community-dwelling
* Sedentary or insufficiently active as measured by the PAVS
* Access to Wi-Fi in defined exercise space
* BMI of 20-34.9 kg/m2
* Document medication specific to OA and knee pain
* Willing and able to provide consent
Exclusion Criteria:
* Neurological conditions causing functional impairments (Parkinson's disease, MS, ALS)
* Diagnosis of dementia
* Inability to complete ≥1 ADLs without assistance.
* Knee surgery in the past 6 months
* Severe osteoporosis T-score \< -3.5
* No concurrent enrollment in physical therapy for knee pain
* No concurrent enrollment in the Intermountain Arthrofit program
* Under the age of 55 or ≥85
* Asymptomatic OA
* Not having knee pain or having significant knee pain (WOMAC Pain score of ≤3 or ≥18)
* KL Grade 1 or 4
* BMI above 34.9 kg/m2 or ≤20 kg/m2
* Participation in formal strength training more than 30 minutes a week in the past 6 months.
* PAVS - Participating in 150 minutes per week of moderate intensity physical activity or 75 minutes of vigorous intensity activity, or an equivalent combination of moderate and vigorous intensity physical activity.
* Co-morbid disease that would threaten safety or impair ability to participate in a live and interactive strength training program
* Symptomatic or severe coronary artery disease; peripheral vascular disease
* Untreated hypertension
* Active cancer other than skin cancer
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
85 Years
Study:
NCT06462560
Study Brief:
Protocol Section:
NCT06462560