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:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-26 @ 5:23 PM
NCT ID:
NCT05631106
Eligibility Criteria:
Inclusion Criteria:
* Lives within 20 miles of the school
* Does not plan to travel outside the home geographic area for an extended period during the study participation
* Willing to provide informed consent
* Willing to be randomized to either lifestyle intervention group
* Willing to complete all study procedures and assessments
* No contraindications to exercise
* Capacity to complete physical exercise
Exclusion Criteria:
* Dependent on walking device
* Claustrophobia
* Performs 30 minutes of moderate intensity exercise three times per week for the previous three months
* Joint replacement or orthopedic surgery in the previous 6-months or planning to have surgery in the next 6-months
* Uncontrolled hypertension
* Pathological neurological condition
* Parkinson's disease
* Unstable depression, anxiety, or schizophrenia (medication changes in the past 6 months)
* Experienced a concussion within the last 6 months
* Respiratory disease requiring oxygen
* Cancer requiring treatment
* Osteoarthritis
* Osteopenia or Osteoporosis
* Body mass index under 18
* Muscle wasting disease
* Hypertrophic or dilated cardiomyopathy significant cardiovascular disease (NIHA Class III/IV congestive heart failure, aortic stenosis, history of cardiac arrest, uncontrolled angina)
* Currently receiving physical therapy or cardiopulmonary rehabilitation
* Type I or insulin dependent Type II Diabetes
* Any implanted medical devices that are not compatible with fMRI scans (cardiac pacemaker or implanted cardiac defibrillator (ICD))
* Metal shavings in eyes
* Ferromagnetic piercings that cannot be taken out
* Transdermal patches that cannot be removed
* Cerebral aneurysm clip
* \>14 alcoholic drinks in one week
* Not receiving medical clearance after PARQ+
* Evidence of cognitive impairment (Scoring below 32 points on the Telephone Interview of Cognitive Status)
* Site PI/Study Clinician discretion regarding medical status, appropriateness of participation or concern about intervention adherence, clinical judgement
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT05631106
Study Brief:
Protocol Section:
NCT05631106