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 @ 4:03 AM
Ignite Modification Date:
2025-12-25 @ 4:03 AM
NCT ID:
NCT05220202
Eligibility Criteria:
Inclusion Criteria:
* Aged 60 and older
* English- speaking
* Self-reported MSK pain (include cLBP +/- radiating symptoms, OA, fibromyalgia) on most days for the past 3 months that interferes with daily activities
* Pain intensity that is 4+/10 on the numerical pain rating scale
* Pain interference threshold 5+ on PEG-3
* Depressive symptoms, 10+ on PHQ-9
* Capable of participating in home-based activity
* Interested in participating in a non-pharmacologic program
Exclusion Criteria:
* Aged 59 or less
* No telephone
* Not English speaking
* Unwilling to be randomized to either study arm
* Not interested in participating in a non-pharmacologic program
* Self-reported uncorrected hearing and visual impairments precluding ability to participate in telephone sessions or read pedometer screen
* Significant (moderate or severe) cognitive impairment (3+ errors) on six-item screening exam
* Self-reported dependence on wheelchair, bed-bound, or severe balance impairment or severe OA\* (resulting in inability to participate in physical activity intervention)
* Illness requiring hospitalization within the last 3 months that interferes with a home-based physical activity intervention (e.g., fall, gout attack, stroke, heart attack, heart failure, surgery for blocked arteries)
* Suicidal intent (see suicide screening protocol), uncontrolled psychotic disorder or psychiatric hospitalization within 1 year, or enrolled in active substance use program (confirmed with scripted protocol over telephone)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
99 Years
Study:
NCT05220202
Study Brief:
Protocol Section:
NCT05220202