Mild Cognitive ImpairmentNCT03855475
Aging Brain Structure and Memory in Response to Exercise
A study testing Aerobic exercise and Stretching in people with Mild Cognitive Impairment, run by University of Delaware at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Aerobic exercise and Stretching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mechanical Integrity of Memory Systems in Mild Cognitive Impairment
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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Aerobic exercise, Stretching
- Keywords
- Exercise, Memory, Brain
- Medical subject headings
- Cognitive Dysfunction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseBehavioural
Participants will complete 12 weeks of supervised aerobic exercise, 3 times per week, on a treadmill or stationary bicycle
StretchingBehavioural
Participants will complete 12 weeks of supervised stretching, 3 times per week
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise | Experimental | Exercise training Receives: Behavioral: Aerobic exercise |
| Stretching | Active comparator | Control Receives: Behavioral: Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 12 weeks
Secondary outcomes (2)
Change in relational memory performance
Behavioral memory test will be used to assess relational memory through accuracy on a spatial reconstruction task.
Measured: Baseline, 12 weeks
Change in cardiorespiratory fitness
Graded exercise test will measure cardiorespiratory fitness through volume of oxygen uptake (VO2)
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start1 Mar 2019
- Primary completion31 Dec 2023
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Collaborators
- Christiana Care Health Services, University of Illinois at Urbana-Champaign, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Curtis L Johnson, PhD, Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03855475
- Sponsor's protocol ID
- 1256861
- Other IDs
- R01AG058853
- Status last verified
- May 2024
- First submitted
- 14 Feb 2019
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Integrity of Memory Systems in Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT03855475
- Acronym / sponsor ID
- 1256861
- Conditions
- Mild Cognitive Impairment
- Keywords
- Exercise, Memory, Brain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Collaborators
- Christiana Care Health Services, University of Illinois at Urbana-Champaign, National Institute on Aging (NIA)
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 26 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise | Experimental | Behavioral: Aerobic exerciseExercise training |
| Stretching | Active comparator | Behavioral: StretchingControl |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exerciseParticipants will complete 12 weeks of supervised aerobic exercise, 3 times per week, on a treadmill or stationary bicycle | Behavioural | Aerobic exercise |
| StretchingParticipants will complete 12 weeks of supervised stretching, 3 times per week | Behavioural | Stretching |
Primary outcome
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).
2 secondary outcomes
Change in relational memory performance
Time frame: Baseline, 12 weeks
Change in cardiorespiratory fitness
Time frame: Baseline, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Curtis L Johnson, PhD principal investigator
University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise and Stretching in people with Mild Cognitive Impairment, run by University of Delaware at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in brain mechanical properties (time frame: Baseline, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.