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 @ 6:41 PM
Ignite Modification Date:
2025-12-24 @ 6:41 PM
NCT ID:
NCT06089057
Eligibility Criteria:
Inclusion Criteria:
* Participant's nephrologist and/or primary care physician agree that participant may enroll in trial
* Participants classified as pre-frail per Fried Frailty phenotype due to slowness (time taken to walk 15 feet is greater than 6 seconds) in Aim 1, OR who report 'YES' to any of the following:
* "For health or physical reasons, do you have difficulty in walking a mile (5-6 blocks)?", OR
* "If no, have you changed the way you walk half a mile (5-6 blocks) because of underlying health problems?", OR
* "For health or physical reasons, do you have difficulty in climbing 1 flight of stairs (10 steps)?", OR
* "If no, have you changed the way you climb 1 flight of stairs (10 steps) because of health problems?"
Exclusion Criteria:
* Myocardial infarction or unstable angina within the prior six months based on electronic medical record review or self-report
* Uncontrolled cardiac arrythmia within the prior six months based on electronic medical record review or self-report
* Systolic blood pressure \> 180 mm Hg and/or diastolic blood pressure \> 110 mm Hg on more than one occasion within prior six months based on electronic medical record review or self-report
* Cerebrovascular event and/or transient ischemic attack within prior six months based on electronic medical record review or self-report
* Abnormal cardiac stress test within the past year based on electronic medical record review or self-report
* Hemoglobin of 10 g/dL or less based on electronic medical record review or self-report
* Class IV heart failure based on electronic medical record review or self-report
* Dyspnea and/or chest pain at rest
* Dependence on wheelchair for mobility
* Permanent residence in nursing home or other long-term care facility
* Terminal illness or other hospice-qualifying medical condition
* Planned move away from middle Tennessee within the next year
* Planned major surgery in the next six months
* Blindness
* Concurrent enrollment in physical therapy or structured exercise program
* Anticipated dialysis or kidney transplant in upcoming three months
* Non-English speaking
* Severe cognitive impairment based on electronic medical record review or self-report
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT06089057
Study Brief:
Protocol Section:
NCT06089057