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

Not Applicable

Completed

• Conditions: Healthy Cognition
• Interventions: Other: Exercise Training; Other: Flexibility Control

• Registration Number: NCT03727360
• Lead Sponsor: University of Maryland, College Park

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-08
• Study First Submitted: 2018-10-26
• Study First Submitted QC: 2018-10-30
• Study First Posted: 2018-11-01
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise Training	Exercise Training	Group exercise and treadmill walking
Flexibility Control	Flexibility Control	Group exercise and flexibility exercise

Primary Outcome Measures

Name	Time	Method
Change from Baseline to 6 months in Resting Cerebral Blood Flow	Baseline and 6 months
Change from Baseline to 6 months in Rey Auditory Verbal Learning Test Sum of Trials 1-5	Baseline and 6 months

Secondary Outcome Measures

Name	Time	Method
Change from Baseline to 6 months in 6 Minute Walk Test	Baseline and 6 months	Distance walked in 6 minutes
Change from Baseline to 6 months in VO2peak	Baseline and 6 months	Estimated peak rate of oxygen consumption, a measure of cardiorespiratory fitness

Trial Locations

Locations (1)

University of Maryland, Department of Kinesiology; 🇺🇸 College Park, Maryland, United States