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Exercise for Brain Health in the Fight Against Alzheimer's Disease

University of Maryland logo

University of Maryland

Status

Completed

Conditions

Healthy Cognition

Treatments

Other: Exercise Training
Other: Flexibility Control

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03727360
1R01AG057552 (U.S. NIH Grant/Contract)
1115946

Details and patient eligibility

About

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.

Enrollment

124 patients

Sex

All

Ages

60 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

124 participants in 2 patient groups

Exercise Training
Experimental group
Description:
Group exercise and treadmill walking
Treatment:
Other: Exercise Training
Flexibility Control
Active Comparator group
Description:
Group exercise and flexibility exercise
Treatment:
Other: Flexibility Control

Trial contacts and locations

1

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Central trial contact

Study Coordinator

Data sourced from clinicaltrials.gov

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