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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 4, 2020
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Johns Hopkins University
Marquette University
University of Maryland, Baltimore
Information provided by (Responsible Party):
University of Maryland, College Park

Tracking Information
First Submitted Date  ICMJE October 26, 2018
First Posted Date  ICMJE November 1, 2018
Last Update Posted Date November 4, 2020
Actual Study Start Date  ICMJE October 8, 2018
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2018)
  • Change from Baseline to 6 months in Rey Auditory Verbal Learning Test Sum of Trials 1-5 [ Time Frame: Baseline and 6 months ]
  • Change from Baseline to 6 months in Resting Cerebral Blood Flow [ Time Frame: Baseline and 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2018)
  • 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
  • Change from Baseline to 6 months in 6 Minute Walk Test [ Time Frame: Baseline and 6 months ]
    Distance walked in 6 minutes
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exercise for Brain Health in the Fight Against Alzheimer's Disease
Official Title  ICMJE Exercise for Brain Health in the Fight Against Alzheimer's Disease
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Healthy Cognition
Intervention  ICMJE
  • Other: Exercise Training
    Supervised exercise conducted four days per week for six months.
  • Other: Flexibility Control
    Supervised exercise conducted four days per week for six months.
Study Arms  ICMJE
  • Experimental: Exercise Training
    Group exercise and treadmill walking
    Intervention: Other: Exercise Training
  • Active Comparator: Flexibility Control
    Group exercise and flexibility exercise
    Intervention: Other: Flexibility Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 30, 2018)
152
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2023
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Study Coordinator 301-405-2574 exercisebrainhealth@gmail.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03727360
Other Study ID Numbers  ICMJE 1115946
1R01AG057552 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Maryland, College Park
Study Sponsor  ICMJE University of Maryland, College Park
Collaborators  ICMJE
  • National Institute on Aging (NIA)
  • Johns Hopkins University
  • Marquette University
  • University of Maryland, Baltimore
Investigators  ICMJE
Principal Investigator: J. Carson Smith, PhD University of Maryland, College Park
PRS Account University of Maryland, College Park
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP