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 @ 5:13 PM
Ignite Modification Date:
2025-12-24 @ 5:13 PM
NCT ID:
NCT05972850
Eligibility Criteria:
Inclusion Criteria:
* 60 - 80 years
* Lives in a rural area based on established urban-rural definitions (e.g., RUCA codes, RUCC, UIC)
* A qualifying Cardio Vascular Disease (CVD) event or procedure
* Cognitively unimpaired Telephone Interview for Cognitive Status (TICS-m ≥32)
* No major depressive symptoms Patient Health Questionnaire (PHQ-8 \<10)
* Ambulatory and community-dwelling
* Less than 150 min per week of moderate-to-intensive aerobic or resistance exercise in the past month
* Medically cleared for exercise if event was within the last 6 months
* Access to a tablet or computer and internet/Wi-Fi in defined exercise space
* Able to provide own transportation to study visits
* Not participating in a clinical trial
* Willing to provide informed consent
Exclusion Criteria:
* \<60 years or \>80 years
* Lives in non-rural area
* No CVD or a qualifying event or procedure
* Dementia or severe cognitive impairment (TICS-m \<32)
* Clinical depression (PHQ-8 ≥10)
* Non-ambulatory, institutionalized, or requires walker
* Regular aerobic or resistance exercise (including current participation in a cardiac rehab program)
* Not medically cleared for exercise
* Advanced kidney disease requiring dialysis or dialysis anticipated within 6 months
* Insulin-dependent diabetes
* Use of any supplemental oxygen for COPD
* Significant impairment from a prior stroke
* Progressive neurologic disease (Parkinson's, ALS, multiple sclerosis, Alzheimer's disease, dementia)
* Severe arthritis, fracture, chronic injury, or other musculoskeletal disorder that prevents walking independently
* Cancer (not including non-melanoma skin cancers) requiring treatment with the past year
* Excessive alcohol consumption (\>7/week alcoholic beverages for women and \>14/week for men) in the past month
* Joint replacement or other orthopedic surgery in past 12 months or planned in next 6 months
* No computer, tablet or internet access
* No access to transportation for travel to study visits
* Current participation in a clinical trial
* Inability or unwillingness to comply with the study requirements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
80 Years
Study:
NCT05972850
Study Brief:
Protocol Section:
NCT05972850