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Completed

NCT Number: NCT03727360

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

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.

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Key information

Conditions

Healthy Cognition

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maryland, Department of Kinesiology

College Park, Maryland, 20742, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise training

Other

Supervised exercise conducted four days per week for six months.

Flexibility Control

Other

Supervised exercise conducted four days per week for six months.

Primary outcomes

  1. Rey Auditory Verbal Learning Test Sum of Trials 1-5

    Time frame: Baseline and 6 months

    Rey Auditory Verbal Learning Test Sum of Trials 1-5. Fifteen words are presented verbally, and participant is asked to recall as many as possible after each trial. The total sum of the words correctly recalled across trials 1 to 5 is recorded.

  2. Famous Name Discrimination fMRI Activation

    Time frame: Baseline and 6 months

    Famous minus Not Famous Name Discrimination activation using event-related fMRI (correct trials only), derived from standard preprocessing and control of family-wise error rate. The primary outcome reflects the mean activation intensity from all brain regions that were shown to be activated by the task in both the Exercise Training and Flexibility Control conditions.

Secondary outcomes

  1. Peak Rate of Oxygen Consumption (VO2peak)

    Time frame: Baseline and 6 months

    Estimated peak rate of oxygen consumption during a treadmill graded exercise test, a measure of cardiorespiratory fitness.

  2. 6 Minute Walk Test

    Time frame: Baseline and 6 months

    Distance walked in 6 minutes

Sponsors and collaborators

Lead sponsor

University of Maryland, College Park

Other

Collaborators

  • Johns Hopkins University
  • Marquette University
  • National Institute on Aging (NIA)
  • University of Maryland, Baltimore

Registry information

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Nov 1, 2018
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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