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 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT03896035
Eligibility Criteria:
Inclusion Criteria:
* Men and women Veterans aged 65+
* English-speaking
* Self-reported low back pain (+/-radiation) on most days for the past 3 months, that interferes with daily activities. Low back pain interferes with daily activities, assessed with the question "does your back pain limit your ability to do activities around the home or activities that you enjoy?"
* Chronic low back pain with intensity of 4 or higher on 10 point scale
* Depression, PHQ-9\>10 stable (per chart review, no psychotic or suicidal ideation; confirmed over telephone)
* Capable of participating in home-based activity
Exclusion Criteria:
* No telephone
* Not English speaking
* Unwilling to be randomized to either study arm
* Self-reported uncorrected hearing or visual disturbance precluding ability to participate in telephone sessions or read pedometer screen
* Cognitive impairment, assessed by Memory Impairment Screen
* Lumbar surgery within the last year
* Self-reported dependence on wheelchair, bed-bound, or severe balance impairment (unable to participate in physical activity intervention)
* Illness requiring hospitalization within the last 3 months. Specific question: Have you been hospitalized for an illness in the past 3 months that would make participating in a physical activity program challenging or unsafe? (Examples include: fall, gout attacks, stroke, heart attack, heart failure, or surgery for blocked arteries)
* Suicidal ideation, prior psychotic episodes requiring hospitalization within the last year
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT03896035
Study Brief:
Protocol Section:
NCT03896035