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

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ClinicalTrials.gov Identifier: NCT03727360
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : November 1, 2018
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Johns Hopkins University
Marquette University
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Cognition Other: Exercise Training Other: Flexibility Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Participants and outcomes assessors are masked to APOE genotype. We do not share any data with care providers.
Primary Purpose: Other
Official Title: Exercise for Brain Health in the Fight Against Alzheimer's Disease
Actual Study Start Date : October 8, 2018
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023


Arm Intervention/treatment
Experimental: Exercise Training
Group exercise and treadmill walking
Other: Exercise Training
Supervised exercise conducted four days per week for six months.

Active Comparator: Flexibility Control
Group exercise and flexibility exercise
Other: Flexibility Control
Supervised exercise conducted four days per week for six months.




Primary Outcome Measures :
  1. Change from Baseline to 6 months in Rey Auditory Verbal Learning Test Sum of Trials 1-5 [ Time Frame: Baseline and 6 months ]
  2. Change from Baseline to 6 months in Resting Cerebral Blood Flow [ Time Frame: Baseline and 6 months ]

Secondary Outcome Measures :
  1. Change from Baseline to 6 months in VO2peak [ Time Frame: Baseline and 6 months ]
    Estimated peak rate of oxygen consumption, a measure of cardiorespiratory fitness

  2. Change from Baseline to 6 months in 6 Minute Walk Test [ Time Frame: Baseline and 6 months ]
    Distance walked in 6 minutes



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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727360


Contacts
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Contact: Study Coordinator 301-405-2574 exercisebrainhealth@gmail.com

Locations
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United States, Maryland
University of Maryland, Department of Kinesiology Recruiting
College Park, Maryland, United States, 20742
Contact: Study Coordinator    301-405-2574    exercisebrainhealth@gmail.com   
Sponsors and Collaborators
University of Maryland, College Park
National Institute on Aging (NIA)
Johns Hopkins University
Marquette University
Investigators
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Principal Investigator: J. Carson Smith, PhD University of Maryland, College Park

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Responsible Party: University of Maryland, College Park
ClinicalTrials.gov Identifier: NCT03727360     History of Changes
Other Study ID Numbers: 1115946
1R01AG057552 ( U.S. NIH Grant/Contract )
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Maryland, College Park:
Walking Exercise
Flexibility Exercise
Cognition
Memory
Magnetic Resonance Imaging
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders