Healthy AgingAEROBICNCT04299308
Acute Exercise and the Cerebral Metabolic Response in Aging and Alzheimer's Disease
A study testing Aerobic Exercise in people with Healthy Aging and Alzheimer Disease, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The overall goal is to characterize the acute exercise response as it relates to brain glucose metabolism in aging and Alzheimer's Disease (AD). The study team will also examine lactate metabolism, relationships with cognition, and the effect of exercise intensity. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging, Alzheimer Disease
- What is being tested?
- Aerobic Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2020to 31 Oct 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 60 and older
- Stable medication doses (>1month)
- Post-menopausal
- Diagnosis of either Nondemented (CDR 0) or Probable AD (CDR 0.5 or 1 only)
Who cannot join
- Inability to provide consent
- Diagnosis of insulin-dependent (Type 1) Diabetes Mellitus
- Recent ischemic heart disease (<2 years)
- Diagnosis of an clinically significant chronic disease including cardiovascular disease (CVD), other metabolic diseases (e.g., thyroid), cancer, human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome
- Excluded from or unable to complete an MRI scan
- Any Neurological disorders that have the potential to impair cognition or brain metabolism (e.g., Parkinson's disease, stroke defined as a clinical episode with neuroimaging evidence in an appropriate area to explain the symptoms).
- Clinically significant depressive symptoms that may impair cognition, abnormalities in B12, rapid plasma regain (RPR), or thyroid function that may impair cognition, use of psychoactive and investigational medications, and significant visual or auditory impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
Univeristy of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Acute Exercise Response On Brain Imaging and Cognition
The overall goal is to characterize the acute exercise response as it relates to brain glucose metabolism in aging and Alzheimer's Disease (AD). The study team will also examine lactate metabolism, relationships with cognition, and the effect of exercise intensity.
Read the detailed description
Aim 1: Compare the effects of acute, moderate intensity and acute, higher intensity exercise on cerebral glucose metabolism in nondemented (ND) elderly and AD subjects. ND (n=30) and AD (n=30) subjects will undergo a single bout of moderate intensity (45-55% HRR) or higher intensity (65-75% HRR) exercise to assess the effect of exercise intensity on acute change in brain glucose metabolism (rest to exercise). Investigators hypothesize that both moderate and high intensity exercise will elicit a drop in global brain glucose metabolism compared to quiet rest, but that the effect will be greater with higher intensity vs. moderate intensity exercise, and greater in ND subjects than in AD subjects.
Aim 2: Characterize the effect of both exercise intensities on acute biomarker response and cognition (memory and executive function) in ND and AD subjects. The acute biomarker response to exercise and the effect on cognition has not been examined in aged or AD cohorts. Investigators hypothesize that acute higher intensity exercise will elicit a greater blood lactate response (area under the curve, AUC) compared to acute moderate intensity exercise, and that this response will be greater in ND than in AD subjects. Investigators further hypothesize that lactate AUC will track negatively with change in cerebral glucose metabolism and cognitive performance. Although investigators will focus on lactate, they will also quantify additional exercise-related biomarkers.
- Conditions
- Healthy Aging, Alzheimer Disease
- Being tested
- Aerobic Exercise
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseBehavioural
Participants will exercise for 15 minutes based on heart rate range. The study team will employ a stationary bike to maintain control over workload
| Study group | Role | What they receive |
|---|---|---|
| Moderate Intensity Aerobic Exercise | Experimental | 45-55% of heart rat reserve (HHR) Low range = ((Max HR from Visit 1) - Resting HR ) * 0.45 + Resting HR High range = ((Max HR from Visit 1) - Resting HR) * 0.55 + Resting HR Receives: Behavioral: Aerobic Exercise |
| High Intensity Aerobic Exercise | Experimental | 65-75% of heart rat reserve (HHR) Low range = ((Max HR from Visit 1) - Resting HR ) * 0.65 + Resting HR High range = ((Max HR from Visit 1) - Resting HR) * 0.75 + Resting HR Receives: Behavioral: Aerobic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) Metabolism (Standard Uptake Value Ratio)
FDG PET measures reflecting cerebral metabolism standardized to the uptake value of the cerebellum and standardized uptake value ratios (SUVR) calculated from native-space region of interest (ROI).
Measured: Resting Vs acute exercise bout: ~1 month
Secondary outcomes (2)
Lactate Area Under the Curve
Change in lactate AUC between the resting and exercise condition
Measured: Resting Vs acute exercise bout: ~1 month
Brain-derived Neurotrophic Factor (BDNF) Change
Pre/post change in circulating Brain Derived Neurotrophic Factor between the resting and exercise conditions
Measured: Resting Vs acute exercise bout: ~1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start28 Aug 2020
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- 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
- Model description
- 2 arm, cross-sectional
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299308
- Sponsor's protocol ID
- STUDY00142140
- Other IDs
- 1R01AG062548-01A1
- Acronym
- AEROBIC
- Status last verified
- Jul 2025
- First submitted
- 4 Mar 2020
- Last updated
- 23 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Green ZD, John CS, Kueck PJ, Blankenship AE, Kemna RE, Johnson CN, Yoksh LE, Best SR, Donald JS, Mahnken JD, Burns JM, Vidoni ED, Morris JK. Acute exercise alters brain glucose metabolism in aging and Alzheimer's disease. J Physiol. 2026 Mar;604(6):2473-2490. doi: 10.1113/JP286923. Epub 2024 Sep 11.
PubMed 39258961Green ZD, John CS, Kueck PJ, Burns JM, Perry M, Donald J, Mahnken JD, Honea RA, Vidoni ED, Morris JK. Rationale and methods to characterize the acute exercise response in aging and Alzheimer's Disease: the AEROBIC pilot study. Contemp Clin Trials. 2021 Aug;107:106457. doi: 10.1016/j.cct.2021.106457. Epub 2021 May 27.
PubMed 34051350
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Exercise Response On Brain Imaging and Cognition
- ClinicalTrials.gov ID
- NCT04299308
- Acronym / sponsor ID
- AEROBIC / STUDY00142140
- Conditions
- Healthy Aging, Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 28 Aug 2020 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 6 Mar 2020 (actual)
- Results
- Posted 23 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal is to characterize the acute exercise response as it relates to brain glucose metabolism in aging and Alzheimer's Disease (AD). The study team will also examine lactate metabolism, relationships with cognition, and the effect of exercise intensity.
Detailed description
Aim 1: Compare the effects of acute, moderate intensity and acute, higher intensity exercise on cerebral glucose metabolism in nondemented (ND) elderly and AD subjects. ND (n=30) and AD (n=30) subjects will undergo a single bout of moderate intensity (45-55% HRR) or higher intensity (65-75% HRR) exercise to assess the effect of exercise intensity on acute change in brain glucose metabolism (rest to exercise). Investigators hypothesize that both moderate and high intensity exercise will elicit a drop in global brain glucose metabolism compared to quiet rest, but that the effect will be greater with higher intensity vs. moderate intensity exercise, and greater in ND subjects than in AD subjects.
Aim 2: Characterize the effect of both exercise intensities on acute biomarker response and cognition (memory and executive function) in ND and AD subjects. The acute biomarker response to exercise and the effect on cognition has not been examined in aged or AD cohorts. Investigators hypothesize that acute higher intensity exercise will elicit a greater blood lactate response (area under the curve, AUC) compared to acute moderate intensity exercise, and that this response will be greater in ND than in AD subjects. Investigators further hypothesize that lactate AUC will track negatively with change in cerebral glucose metabolism and cognitive performance. Although investigators will focus on lactate, they will also quantify additional exercise-related biomarkers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 arm, cross-sectional
| Arm | Type | Receives |
|---|---|---|
| Moderate Intensity Aerobic Exercise | Experimental | Behavioral: Aerobic Exercise45-55% of heart rat reserve (HHR) Low range = ((Max HR from Visit 1) - Resting HR ) * 0.45 + Resting HR High range = ((Max HR from Visit 1) - Resting HR) * 0.55 + Resting HR |
| High Intensity Aerobic Exercise | Experimental | Behavioral: Aerobic Exercise65-75% of heart rat reserve (HHR) Low range = ((Max HR from Visit 1) - Resting HR ) * 0.65 + Resting HR High range = ((Max HR from Visit 1) - Resting HR) * 0.75 + Resting HR |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 60 and older
- Stable medication doses (>1month)
- Post-menopausal
- Diagnosis of either Nondemented (CDR 0) or Probable AD (CDR 0.5 or 1 only)
Key exclusion criteria (7 listed)
- Inability to provide consent
- Diagnosis of insulin-dependent (Type 1) Diabetes Mellitus
- Recent ischemic heart disease (<2 years)
- Diagnosis of an clinically significant chronic disease including cardiovascular disease (CVD), other metabolic diseases (e.g., thyroid), cancer, human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome
- Excluded from or unable to complete an MRI scan
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 exercise for 15 minutes based on heart rate range. The study team will employ a stationary bike to maintain control over workload | Behavioural | High Intensity Aerobic Exercise, Moderate Intensity Aerobic Exercise |
Primary outcome
Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) Metabolism (Standard Uptake Value Ratio)
Time frame: Resting Vs acute exercise bout: ~1 month
FDG PET measures reflecting cerebral metabolism standardized to the uptake value of the cerebellum and standardized uptake value ratios (SUVR) calculated from native-space region of interest (ROI).
2 secondary outcomes
Lactate Area Under the Curve
Time frame: Resting Vs acute exercise bout: ~1 month
Brain-derived Neurotrophic Factor (BDNF) Change
Time frame: Resting Vs acute exercise bout: ~1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 39258961Green ZD, John CS, Kueck PJ, Blankenship AE, Kemna RE, Johnson CN, Yoksh LE, Best SR, Donald JS, Mahnken JD, Burns JM, Vidoni ED, Morris JK. Acute exercise alters brain glucose metabolism in aging and Alzheimer's disease. J Physiol. 2026 Mar;604(6):2473-2490. doi: 10.1113/JP286923. Epub 2024 Sep 11.
- Background: PubMed 34051350Green ZD, John CS, Kueck PJ, Burns JM, Perry M, Donald J, Mahnken JD, Honea RA, Vidoni ED, Morris JK. Rationale and methods to characterize the acute exercise response in aging and Alzheimer's Disease: the AEROBIC pilot study. Contemp Clin Trials. 2021 Aug;107:106457. doi: 10.1016/j.cct.2021.106457. Epub 2021 May 27.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Healthy Aging and Alzheimer Disease, run by University of Kansas Medical Center 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 4 inclusion and 7 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 23 Jul 2025. 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 23 Jul 2025). 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?
Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) Metabolism (Standard Uptake Value Ratio) (time frame: Resting Vs acute exercise bout: ~1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04299308, which also lists 2 linked publications.
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 23 Jul 2025.