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CompletedNCT03855475Updated May 14, 2024

Aging Brain Structure and Memory in Response to Exercise

An interventional study of Aerobic exercise and Stretching in Mild Cognitive Impairment, sponsored by University of Delaware. Completed at 1 site in United States. Open to participants aged 60 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-05-14.

Sponsored by University of Delaware · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
60 Years to 90 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Mild Cognitive Impairment

Keywords

  • Exercise
  • Memory
  • Brain
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In context

Cognitive Dysfunction

3,842 studies on the registry are indexed under Cognitive Dysfunction; 1,099 are open to participants now.

This study's enrollment of 36 is below the median of 65 across 2,807 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

University of Delaware is the lead sponsor of 125 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    Aerobic exercise

    Exercise training

    Behavioral: Aerobic exercise

  • Active comparator
    Stretching

    Control

    Behavioral: Stretching

Interventions

  • BehavioralAerobic exercise

    Participants will complete 12 weeks of supervised aerobic exercise, 3 times per week, on a treadmill or stationary bicycle

  • BehavioralStretching

    Participants will complete 12 weeks of supervised stretching, 3 times per week

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What researchers measure

Primary outcomes

  1. Change in brain mechanical properties

    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).

    Time frame: Baseline, 12 weeks

Secondary outcomes

  1. Change in relational memory performance

    Behavioral memory test will be used to assess relational memory through accuracy on a spatial reconstruction task.

    Time frame: Baseline, 12 weeks

  2. Change in cardiorespiratory fitness

    Graded exercise test will measure cardiorespiratory fitness through volume of oxygen uptake (VO2)

    Time frame: Baseline, 12 weeks

Other outcomes

  1. Change in brain morphometry

    MRI will be used to measure brain morphometry, i.e. volume

    Time frame: Baseline, 12 weeks

  2. Change in brain function

    MRI will be used to measure brain function, i.e. functional connectivity

    Time frame: Baseline, 12 weeks

  3. Change in brain white matter integrity

    Diffusion MRI will be used to measure integrity of white matter tracts

    Time frame: Baseline, 12 weeks

  4. Change in cognitive function

    NIH Toolbox will be used to assess cognitive function across several domains

    Time frame: Baseline, 12 weeks

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Study locations

1 site
  • University of Delaware
    Newark, Delaware 19713, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03855475
Lead sponsor
University of Delaware
Collaborators
Christiana Care Health Services, University of Illinois at Urbana-Champaign, National Institute on Aging (NIA)
Responsible party
Sponsor
First posted
Feb 26, 2019
Start date
Mar 1, 2019
Primary completion
Dec 31, 2023
Completion
Mar 31, 2024
Last update
May 14, 2024

Study contacts

Curtis L Johnson, PhD
principal investigator · University of Delaware

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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