Healthy CognitionNCT03727360
Exercise for Brain Health in the Fight Against Alzheimer's Disease
A study testing Exercise Training in people with Healthy Cognition, run by University of Maryland, College Park at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Cognition
- What is being tested?
- Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2018to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, Department of Kinesiology
College Park, Maryland, 20742
About this study
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.
- Conditions
- Healthy Cognition
- Being tested
- Exercise Training, Flexibility Control
- Keywords
- Walking Exercise, Flexibility Exercise, Cognition, Memory, Magnetic Resonance Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TrainingOther
Supervised exercise conducted four days per week for six months.
Flexibility ControlOther
Supervised exercise conducted four days per week for six months.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Training | Experimental | Group exercise delivered synchronously on Zoom including: warmup, static stretching of all major muscle groups (neck, shoulders, arms, trunk, hips, legs and ankles), balance and toning exercise, marching in place, dynamic cardiovascular exercise at 60-70% of maximal heart rate, cool down. One hour per session, four sessions per week, 26 weeks. Receives: Other: Exercise Training |
| Flexibility Control | Active comparator | Group exercise delivered synchronously on Zoom including: warmup, static stretching of all major muscle groups (neck, shoulders, arms, trunk, hips, legs and ankles), balance and toning exercise, marching in place, seated or floor exercise at 30-40% of maximal heart rate, cool down. One hour per session, four sessions per week, 26 weeks. Receives: Other: Flexibility Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rey Auditory Verbal Learning Test Sum of Trials 1-5
Rey Auditory Verbal Learning Test Sum of Trials 1-5. Fifteen words are presented verbally, and participant is asked to recall as many as possible after each trial. The total sum of the words correctly recalled across trials 1 to 5 is recorded.
Measured: Baseline and 6 months
Famous Name Discrimination fMRI Activation
Famous minus Not Famous Name Discrimination activation using event-related fMRI (correct trials only), derived from standard preprocessing and control of family-wise error rate. The primary outcome reflects the mean activation intensity from all brain regions that were shown to be activated by the task in both the Exercise Training and Flexibility Control conditions.
Measured: Baseline and 6 months
Secondary outcomes (2)
Peak Rate of Oxygen Consumption (VO2peak)
Estimated peak rate of oxygen consumption during a treadmill graded exercise test, a measure of cardiorespiratory fitness.
Measured: Baseline and 6 months
6 Minute Walk Test
Distance walked in 6 minutes
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start8 Oct 2018
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy CognitionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, College Park
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Johns Hopkins University, Marquette University, University of Maryland, Baltimore
- Responsible party
- Sponsor
- Investigators
- J. Carson Smith, PhD, Principal investigator, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03727360
- Sponsor's protocol ID
- 1115946
- Other IDs
- 1R01AG057552
- Status last verified
- Apr 2026
- First submitted
- 26 Oct 2018
- Last updated
- 1 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise for Brain Health in the Fight Against Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT03727360
- Acronym / sponsor ID
- 1115946
- Conditions
- Healthy Cognition
- Keywords
- Walking Exercise, Flexibility Exercise, Cognition, Memory, Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- University of Maryland, College ParkUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Johns Hopkins University, Marquette University, University of Maryland, Baltimore
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 1 Nov 2018 (actual)
- Results
- Posted 1 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Training | Experimental | Other: Exercise TrainingGroup exercise delivered synchronously on Zoom including: warmup, static stretching of all major muscle groups (neck, shoulders, arms, trunk, hips, legs and ankles), balance and toning exercise, marching in place, dynamic cardiovascular exercise at 60-70% of maximal heart rate, cool down. One hour per session, four sessions per week, 26 weeks. |
| Flexibility Control | Active comparator | Other: Flexibility ControlGroup exercise delivered synchronously on Zoom including: warmup, static stretching of all major muscle groups (neck, shoulders, arms, trunk, hips, legs and ankles), balance and toning exercise, marching in place, seated or floor exercise at 30-40% of maximal heart rate, cool down. One hour per session, four sessions per week, 26 weeks. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Exercise TrainingSupervised exercise conducted four days per week for six months. | Other | Exercise Training |
| Flexibility ControlSupervised exercise conducted four days per week for six months. | Other | Flexibility Control |
Primary outcome
Rey Auditory Verbal Learning Test Sum of Trials 1-5
Time frame: Baseline and 6 months
Rey Auditory Verbal Learning Test Sum of Trials 1-5. Fifteen words are presented verbally, and participant is asked to recall as many as possible after each trial. The total sum of the words correctly recalled across trials 1 to 5 is recorded.
Famous Name Discrimination fMRI Activation
Time frame: Baseline and 6 months
Famous minus Not Famous Name Discrimination activation using event-related fMRI (correct trials only), derived from standard preprocessing and control of family-wise error rate. The primary outcome reflects the mean activation intensity from all brain regions that were shown to be activated by the task in both the Exercise Training and Flexibility Control conditions.
2 secondary outcomes
Peak Rate of Oxygen Consumption (VO2peak)
Time frame: Baseline and 6 months
6 Minute Walk Test
Time frame: Baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
J. Carson Smith, PhD principal investigator
University of Maryland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Training in people with Healthy Cognition, run by University of Maryland, College Park 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 6 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 1 May 2026. 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?
Yes. Results are posted in the registry (first posted 1 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Rey Auditory Verbal Learning Test Sum of Trials 1-5 (time frame: Baseline and 6 months). The study lists 2 primary outcomes in all. 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 1 May 2026.