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Trial record 1 of 1 for:    Mechanical integrity of memory systems in mild cognitive impairment
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Aging Brain Structure and Memory in Response to Exercise

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ClinicalTrials.gov Identifier: NCT03855475
Recruitment Status : Recruiting
First Posted : February 26, 2019
Last Update Posted : April 21, 2023
Sponsor:
Collaborators:
Christiana Care Health Services
University of Illinois at Urbana-Champaign
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Delaware

Study Description
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Brief Summary:
This study will measure brain structure through its mechanical properties, assessed with magnetic resonance elastography, and determine whether it improves with aerobic exercise in older adults with low memory abilities. Additionally, this study will determine if memory abilities improve with exercise and if they are related to brain structure. Overall, this project has the potential to identify how brain health is impacted by exercise in older adults.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Behavioral: Aerobic exercise Behavioral: Stretching Not Applicable

Detailed Description:

Mechanical properties of the human brain, measured with magnetic resonance elastography (MRE), reflect the health of brain tissue. Our previous research has shown that these mechanical properties of the hippocampus are highly sensitive to memory function in young adults. Based on these findings, we believe that these mechanical properties may be strong indicators of memory health in older adults and populations experiencing decline in memory function (i.e. mild cognitive impairment, MCI). Further, our results indicate these properties and associated functions are positively impacted by fitness and exercise training, thus making them potentially ideal markers for brain health in assessing rehabilitation.

The objective of this research is to examine these properties in older adults with and without MCI. We will do the following: (1) determine if there are differences in mechanical properties of memory systems in older adults with and without MCI; (2) establish structure-function relationships between mechanical properties and memory performance in the older adult population; and (3) determine if both mechanical properties and memory performance are impacted by cardiovascular health, both through cross-sectional assessment of aerobic fitness and longitudinal response to exercise training.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Mechanical Integrity of Memory Systems in Mild Cognitive Impairment
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Aerobic exercise
Exercise training
 Behavioral: Aerobic exercise
Participants will complete 12 weeks of supervised aerobic exercise, 3 times per week, on a treadmill or stationary bicycle
Active Comparator: Stretching
Control
 Behavioral: Stretching
Participants will complete 12 weeks of supervised stretching, 3 times per week


Outcome Measures
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Primary Outcome Measures :
  1. Change in brain mechanical properties [ Time Frame: Baseline, 12 weeks ]
    Investigators are assessing change in brain structure through mechanical properties in response to exercise from baseline to the end of the 12 week program. An MRI scan with magnetic resonance elastography (MRE) will be used to measure properties of brain regions important to memory (e.g. hippocampus).


Secondary Outcome Measures :
  1. Change in relational memory performance [ Time Frame: Baseline, 12 weeks ]
    Behavioral memory test will be used to assess relational memory through accuracy on a spatial reconstruction task.

  2. Change in cardiorespiratory fitness [ Time Frame: Baseline, 12 weeks ]
    Graded exercise test will measure cardiorespiratory fitness through volume of oxygen uptake (VO2)


Other Outcome Measures:
  1. Change in brain morphometry [ Time Frame: Baseline, 12 weeks ]
    MRI will be used to measure brain morphometry, i.e. volume

  2. Change in brain function [ Time Frame: Baseline, 12 weeks ]
    MRI will be used to measure brain function, i.e. functional connectivity

  3. Change in brain white matter integrity [ Time Frame: Baseline, 12 weeks ]
    Diffusion MRI will be used to measure integrity of white matter tracts

  4. Change in cognitive function [ Time Frame: Baseline, 12 weeks ]
    NIH Toolbox will be used to assess cognitive function across several domains


Eligibility Criteria
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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cognitive function scores consistent with amnestic mild cognitive impairment based on pre-screening evaluation
  • age 60-90 years
  • MMSE score >24 at time of initial consent

Exclusion Criteria:

  • major psychiatric disorder (e.g. schizophrenia, bipolar disorder, major depression within past two years)
  • neurological or autoimmune conditions affecting cognition (e.g. Parkinson's disease, epilepsy, multiple sclerosis, head trauma with loss of consciousness greater than 30 min, large vessel infarct)
  • other systemic medical illnesses (e.g. cardiovascular disease, cancer, renal failure, diabetes, chronic obstructive pulmonary disease, liver diseases, hypertension)
  • current medication use likely to affect CNS functions (e.g. long active benzodiazepines)
  • failed outcome on the baseline graded exercise test
  • hypertension (systolic 130+ mmHg OR diastolic 80+ mmHg) from baseline blood pressure measurement
  • claustrophobia, metal implants, pacemaker or other factors affecting feasibility and/or safety of MRI scanning
  • concussion within last 2 years and more than 3 lifetime concussions
  • current smoking (including marijuana) within the past 3 months
Contacts and Locations
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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): NCT03855475


Contacts
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Contact: Curtis L Johnson, PhD 302-831-4098 clj@udel.edu

Locations
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United States, Delaware
University of Delaware Recruiting
Newark, Delaware, United States, 19713
Contact: Jane Diehl    302-831-4616    diehlj@udel.edu   
Sponsors and Collaborators
University of Delaware
Christiana Care Health Services
University of Illinois at Urbana-Champaign
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Curtis L Johnson, PhD University of Delaware
More Information
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Responsible Party: University of Delaware
ClinicalTrials.gov Identifier: NCT03855475    
Other Study ID Numbers: 1256861
R01AG058853 ( U.S. NIH Grant/Contract )
First Posted: February 26, 2019    Key Record Dates
Last Update Posted: April 21, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Delaware:
Exercise
Memory
Brain
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders