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 @ 4:13 AM
Ignite Modification Date:
2025-12-25 @ 4:13 AM
NCT ID:
NCT01561820
Eligibility Criteria:
Inclusion Criteria:
Participants:
* Age 60 and up
* Montreal Cognitive Assessment (MoCA) score 16-28
* CDR= 0.5 with memory box at least 0.5.
* Have a person (study partner) who can answer questions about their cognition for the CDR, FAQ and NPI-Q. This should be the same person who will come to all clinic visits whenever possible. This person can be called to answer these questions if unable to come into the clinic.
* Sedentary for past 3 months (\< 45 min /wk of exercise, including walking)
* Able to walk 400 meters in \< 15 min without assistance
* Willing to exercise 4 days a week at Body Check at CompRehab
* Physician approval for participation in the exercise intervention
Buddy:
* No report of memory problem
* MoCA score \> 24 if \> HS education; \> 23 if 9-12 years; \> 22 if ,\< 9 years of education
Exclusion Criteria:
Due to Cognitive Confounders:
* Uncontrolled depression (PHQ-9 \> 10)
* Schizophrenia or bipolar disorder
* Parkinson's disease
* Hachinski ischemic index \> 4
* Daily use of highly anticholinergic medications (such as amitriptyline, diphenhydramine, scopolamine, etc) or benzodiazepines
* Use of stable dose of Cholinesterase inhibitors will be permitted. Must be on a stable dose for 4 weeks.
* Non-English speaking (as we are unable to administer the cognitive tests in languages other than English for this pilot)
* Vitamin B12 deficiency
* Uncontrolled hypothyroidism as measured by TSH blood test
Due to increased risk of or low likelihood of compliance with the exercise program:
* Active ischemic heart disease or angina
* symptomatic heart failure
* stroke
* screening blood pressure SBP \> 170 or \< 90; DBP \> 100 or \< 45
* Parkinson's disease or other neurologic disorder that might make exercise on a treadmill or bike unsafe
* Current or planned treatment for cancer
* peripheral artery disease that limits exercise capacity
* Severe respiratory-disease (e.g., COPD) that limits exercise capacity
* Severe arthritis that limits exercise capacity
* Serious conduction disorder, uncontrolled arrhythmia, or new Q waves or ST-segment depressions (\> 3 mm) on ECG
* Severe anemia (Hgb \< 8)
* Diagnosis of Diabetes and on medication
* Drinks more than 14 alcoholic drinks per week
* Dependent on a cane, walker or other device that would inhibit then from using a treadmill
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT01561820
Study Brief:
Protocol Section:
NCT01561820