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 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT03474302
Eligibility Criteria:
Inclusion Criteria:
1. 65 - 85 years of age
2. African American
3. sedentary or insufficiently active
4. not cognitively impaired
5. physically capable of exercise
6. willing to accept randomization
7. willing to attend group sessions
8. willing to live in the study area for the next 6 months
9. willing to allow researchers to use data for research purposes after study participation is completed
10. free of conditions that would make regular exercise unsafe as deemed by the medical investigator
Exclusion Criteria:
1. unable or unwilling to give informed consent or accept randomization in either study group
2. are cognitively impaired (MMSE score of ≤ 26)
3. are unable to complete physical activity requirements (SPPB ≤ 3, complete 2 minute walk without sitting or resting against a surface)
4. are too active (steps per day \> 50th percentile for age and gender)
5. have uncontrolled hypertension (systolic blood pressure \> 200 mmHg and/or diastolic blood pressure \> 110 mmHg).
6. gave had a hip fracture, hip or knee replacement, or spinal surgery in the past 6 months
7. have had a myocardial infarction, major heart surgery (i.e., valve replacement or bypass surgery), stroke, deep vein thrombosis or pulmonary embolus in the past 6 months
8. are undergoing physical therapy or cardiopulmonary rehabilitation
9. are currently enrolled in another randomized trial involving lifestyle or pharmaceutical interventions
10. have another member of the household that is a participant in PAACE
11. have plans to relocate out of the study area within the next 6 months
12. have uncontrolled diabetes that in the judgment of the MI may interfere with study participation
13. have other medical, psychiatric, or behavioral factors that in the judgment of the Principal or Medical Investigator may interfere with study participation or the ability to follow the intervention protocol
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Maximum Age:
85 Years
Study:
NCT03474302
Study Brief:
Protocol Section:
NCT03474302