Clinical trial NCT03727360: Exercise for Brain Health in the Fight Against Alzheimer's Disease
Official title: Exercise for Brain Health in the Fight Against Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Cognition
Keywords: Walking Exercise
Flexibility Exercise
Cognition
Memory
Magnetic Resonance Imaging
Lead sponsor: University of Maryland, College Park
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Johns Hopkins University
name: Marquette University
name: University of Maryland, Baltimore
First posted: 2018-11-01
Enrollment: 124
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The investigators aim to compare the effects of a 6-month moderate intensity exercise training (ET) intervention to a low intensity flexibility exercise control condition (FC) on brain function, cognition, and physical function in cognitively healthy and physically inactive older adults (ages 60-80). Apolipoprotein E epsilon4 (APOE-ε4) allele carriers are known to be at substantially greater risk for cognitive decline and Alzheimer's disease (AD). Cognitively intact APOE-ε4 allele carriers, and non-carriers, will be randomly assigned to 6-months of either supervised moderate intensity aerobic exercise training (ET) or supervised flexibility exercise control (FC). The ET and FC each contain a group based exercise component and are run in local retirement communities near College Park, MD, or on the University of Maryland College Park campus. The primary aims of the study are to compare pre-intervention to post-intervention changes in episodic memory performance and MRI biomarkers.


Eligibility criteria: Inclusion Criteria:

* 60 to 80 years old
* Fluent in English
* Willingness to make the time commitment to participate in the project, including randomization to treatments
* Physically inactive (physical activity not more than 2 days per week for the past 6 months)
* Physician consent to undergo an exercise stress test and engage in moderate intensity exercise
* Determined to be safe for MRI

Exclusion Criteria:

* Neurological illnesses/conditions such as cerebral palsy, epi¬lepsy, brain tumor, chronic meningitis, multiple scle¬rosis, pernicious anemia, normal-pressure hydrocephalus, HIV infection, Parkinson's disease, and Huntington's disease
* Untreated hypertension, glaucoma, and chronic obstructive pul¬monary disease
* Untreated severe major depression
* Substance abuse or dependence
* Current use of psychoactive medications, except selective serotonin/norepinephrine reuptake inhibitor antidepressants
* Use of acetylcholinesterase inhibitors (e.g., Aricept)
* Unstable or severe cardiovascular disease or asthmatic condition
* History of transient ischemic attack, cerebral ischemia, or clinically diagnosed stroke
* Diagnosis of mild cognitive impairment or dementia, or objective evidence of cognitive impairment

Primary outcomes:
measure: Change from Baseline to 6 months in Rey Auditory Verbal Learning Test Sum of Trials 1-5
timeFrame: Baseline and 6 months
measure: Change from Baseline to 6 months in Resting Cerebral Blood Flow
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change from Baseline to 6 months in VO2peak
timeFrame: Baseline and 6 months
measure: Change from Baseline to 6 months in 6 Minute Walk Test
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: College Park
country: United States
facility: University of Maryland, Department of Kinesiology
state: Maryland
Study officials:
affiliation: University of Maryland
name: J. Carson Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References: