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.

Study Overview

• Status: Completed
• Conditions: Healthy Cognition
• Intervention / Treatment: Other: Exercise Training; Other: Flexibility Control

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • College Park, Maryland, United States, 20742
      • University of Maryland, Department of Kinesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise Training; Group exercise delivered synchronously on Zoom including: warmup, static stretching of all major muscle groups (neck, shoulders, arms, trunk, hips, legs and ankles), balance and toning exercise, marching in place, dynamic cardiovascular exercise at 60-70% of maximal heart rate, cool down. One hour per session, four sessions per week, 26 weeks.	Other: Exercise Training; Supervised exercise conducted four days per week for six months.
Active Comparator: Flexibility Control; Group exercise delivered synchronously on Zoom including: warmup, static stretching of all major muscle groups (neck, shoulders, arms, trunk, hips, legs and ankles), balance and toning exercise, marching in place, seated or floor exercise at 30-40% of maximal heart rate, cool down. One hour per session, four sessions per week, 26 weeks.	Other: Flexibility Control; Supervised exercise conducted four days per week for six months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rey Auditory Verbal Learning Test Sum of Trials 1-5	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.	Baseline and 6 months
Famous Name Discrimination fMRI Activation	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.	Baseline and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Rate of Oxygen Consumption (VO2peak)	Estimated peak rate of oxygen consumption during a treadmill graded exercise test, a measure of cardiorespiratory fitness.	Baseline and 6 months
6 Minute Walk Test	Distance walked in 6 minutes	Baseline and 6 months

Collaborators and Investigators

• Sponsor: University of Maryland, College Park
• Collaborators: Johns Hopkins University; University of Maryland, Baltimore; National Institute on Aging (NIA); Marquette University
• Investigators: Principal Investigator: J. Carson Smith, PhD, University of Maryland

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2018
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: October 26, 2018
• First Submitted That Met QC Criteria: October 30, 2018
• First Posted (Actual): November 1, 2018

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Magnetic Resonance Imaging; Memory; Cognition; Walking Exercise; Flexibility Exercise
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: 1115946; 1R01AG057552 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No