NCT02913053 · COMPLETED
The Effects of an Extensive Exercise Program on the Progression of Mild Cognitive Impairment
This study compares three groups of people with mild cognitive impairment: a 12-month aerobic exercise program, a stretching and toning program, and a group with no program. Researchers want to see whether cognitive and movement-related abilities decline less with aerobic exercise. It is not a drug trial, so there is no phase.
You may qualify if
- Diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) according to the Albert et al (2011) criteria
- Montreal Cognitive Assessment (MoCA) (Nasreddine et al. 2005) score 18-26
- Stable medical condition for more than 6 months
- Stable medications for more than 3 months
- Adequate visual and auditory acuity to complete neuropsychological testin
- Electrocardiogram without significant abnormalities that might interfere with the study
- Physical ability sufficient to allow performance of endurance exercise training
- Capacity to provide written and dated informed consent form
- Medical clearance to undergo a symptom-limited cardiopulmonary exercise test and extensive aerobic exercise training
- Participants recruited from the community via newspaper articles and community advertisement will complete additional testing to determine MCI status. Participants must score ≤1.5 standard deviation (SD) of cut-off scores on episodic memory test
You're excluded if
- Diagnosis of AD or other type of dementia
- History of familial early-onset dementia
- Enrollment onto any investigational drug study
- History in the past 2 years of epileptic seizures (Participants with epilepsy who have been stable off medication and seizure free for 2 years may be included)
- Any major psychiatric disorder (a clinical diagnosis of major depressive disorder, bipolar or schizophrenia)
- Past history or MRI evidence of brain damage, including significant trauma, stroke, hydrocephalus, mental retardation, or serious neurological disorder
- Carotid stent or severe stenosis
- History of myocardial infarction within previous year congestive heart failure (New York Heart Association Class II, III or IV)
- Uncontrolled hypertension or hypotension (systolic blood pressure >200 mm Hg and/or diastolic blood pressure >110 mm Hg at rest)
- Unstable cardiac, renal, lung, liver, or other severe chronic disease
- Type 2 diabetes mellitus with hypoglycemia in the last 3 months
- Significant history of alcoholism or drug abuse within last 10 years
- Significant obesity limiting active participation in the exercise program
- Engagement in moderate-intensity aerobic exercise training for more than 30 minutes, 3 times per week, during past 2 years
- History of vitamin B12 deficiency or hypothyroidism (stable treatment for at least 3 months is allowed)
- Serious or non-healing wound, ulcer, or bone fracture
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2019-11-14