Aging Brain Structure and Memory in Response to Exercise
Primary Purpose
Mild Cognitive Impairment
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aerobic exercise
Stretching
Sponsored by

About this trial
This is an interventional basic science trial for Mild Cognitive Impairment focused on measuring Exercise, Memory, Brain
Eligibility 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
Sites / Locations
- University of DelawareRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Aerobic exercise
Stretching
Arm Description
Exercise training
Control
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Change in relational memory performance
Behavioral memory test will be used to assess relational memory through accuracy on a spatial reconstruction task.
Change in cardiorespiratory fitness
Graded exercise test will measure cardiorespiratory fitness through volume of oxygen uptake (VO2)
Full Information
NCT ID
NCT03855475
First Posted
February 14, 2019
Last Updated
April 19, 2023
Sponsor
University of Delaware
Collaborators
Christiana Care Health Services, University of Illinois at Urbana-Champaign, National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT03855475
Brief Title
Aging Brain Structure and Memory in Response to Exercise
Official Title
Mechanical Integrity of Memory Systems in Mild Cognitive Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Delaware
Collaborators
Christiana Care Health Services, University of Illinois at Urbana-Champaign, National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Exercise, Memory, Brain
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aerobic exercise
Arm Type
Experimental
Arm Description
Exercise training
Arm Title
Stretching
Arm Type
Active Comparator
Arm Description
Control
Intervention Type
Behavioral
Intervention Name(s)
Aerobic exercise
Intervention Description
Participants will complete 12 weeks of supervised aerobic exercise, 3 times per week, on a treadmill or stationary bicycle
Intervention Type
Behavioral
Intervention Name(s)
Stretching
Intervention Description
Participants will complete 12 weeks of supervised stretching, 3 times per week
Primary Outcome Measure Information:
Title
Change in brain mechanical properties
Description
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 Outcome Measure Information:
Title
Change in relational memory performance
Description
Behavioral memory test will be used to assess relational memory through accuracy on a spatial reconstruction task.
Time Frame
Baseline, 12 weeks
Title
Change in cardiorespiratory fitness
Description
Graded exercise test will measure cardiorespiratory fitness through volume of oxygen uptake (VO2)
Time Frame
Baseline, 12 weeks
Other Pre-specified Outcome Measures:
Title
Change in brain morphometry
Description
MRI will be used to measure brain morphometry, i.e. volume
Time Frame
Baseline, 12 weeks
Title
Change in brain function
Description
MRI will be used to measure brain function, i.e. functional connectivity
Time Frame
Baseline, 12 weeks
Title
Change in brain white matter integrity
Description
Diffusion MRI will be used to measure integrity of white matter tracts
Time Frame
Baseline, 12 weeks
Title
Change in cognitive function
Description
NIH Toolbox will be used to assess cognitive function across several domains
Time Frame
Baseline, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Curtis L Johnson, PhD
Phone
302-831-4098
Email
clj@udel.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Curtis L Johnson, PhD
Organizational Affiliation
University of Delaware
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Delaware
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jane Diehl
Phone
302-831-4616
Email
diehlj@udel.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Aging Brain Structure and Memory in Response to Exercise
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