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 @ 5:11 AM
Ignite Modification Date:
2025-12-25 @ 5:11 AM
NCT ID:
NCT02567227
Eligibility Criteria:
Inclusion Criteria:
1. Adults aged 70 and older, residing in the community.
2. Plan to be in area for next year.
3. Able to speak English at a level sufficient to undergo our cognitive assessment battery.
4. Ambulatory. Subjects are classified as 'non-ambulatory' if they are unable to leave the confines of their home and attend a clinic visit.
5. Gait velocity ≤1 m/s.
6. Short Physical Performance Battery score ≤9.
Exclusion Criteria:
1. Presence of dementia identified by any one of the following: Telephone based Memory Impairment Screen score (T-MIS) of \<5, Alzheimer's Disease 8 (AD8) ≥ 2. Or dementia diagnosed by baseline cognitive assessment.
2. Serious chronic or acute illness such as cancer (late stage, metastatic, or on active treatment), chronic pulmonary disease on ventilator or continuous oxygen therapy or active liver disease.
3. Mobility limitations solely due to musculoskeletal limitation or pain (e.g., severe osteoarthritis) that prevent subjects from completing mobility tests. Presence of arthritis will not be used to exclude subjects if they can complete the mobility tasks.
4. Any medical condition or chronic medication use (e.g., neuroleptics) that will compromise safety or affect cognitive functioning or terminal illness with life expectancy less than 12 months.
5. Presence of progressive, degenerative neurologic disease (e.g., Parkinson's disease or ALS).
6. Hospitalized in the past 6 months for severe illness or surgery that specifically affects mobility (e.g. hip or knee replacement) and that prevent subjects from completing mobility tests or plans for surgery affecting mobility in the next 6 months.
7. Severe auditory or visual loss.
8. Active psychoses or psychiatric symptoms (such as agitation) noted during the clinic visit that will prevent completion of study protocols.
9. Living in nursing home.
10. Participation in other intervention trial or observational studies. -
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
70 Years
Study:
NCT02567227
Study Brief:
Protocol Section:
NCT02567227