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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-08

Study Completion Date

2024-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Healthy Cognition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Participants and outcomes assessors are masked to APOE genotype. We do not share any data with care providers.

Study Groups

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Exercise Training

Group exercise and treadmill walking

Group Type EXPERIMENTAL

Exercise Training

Intervention Type OTHER

Supervised exercise conducted four days per week for six months.

Flexibility Control

Group exercise and flexibility exercise

Group Type ACTIVE_COMPARATOR

Flexibility Control

Intervention Type OTHER

Supervised exercise conducted four days per week for six months.

Interventions

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Exercise Training

Supervised exercise conducted four days per week for six months.

Intervention Type OTHER

Flexibility Control

Supervised exercise conducted four days per week for six months.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes