DementiaNCT01738568
Effects of Aging and Aerobic Exercise Training on Brain Glucose Metabolism
A study testing High intensity aerobic training in people with Dementia, run by Mayo Clinic at 1 site in United States.
Trial summary
Aging is associated with a loss of brain function and conditions such as dementia and Alzheimer's disease. It is likely that decreased brain metabolism is contributing to the progression of age related degenerative diseases. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- High intensity aerobic training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to 12 Feb 2015
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-30 years or 65-80 years
Who cannot join
- Body mass index (BMI) >31 kg/m2
- Smoking
- Pregnancy
- Participation in structured exercise (>2 times per week for 30 minutes or longer)
- Cardiovascular, metabolic (type 2 diabetes, fasting plasma glucose at or above 110 mg/dL and untreated hypo- or hyperthyroidism) or renal disease
- Orthopedic problems that would keep them from being able to ride an exercise bicycle, lift weights or do a combination of these exercise
- Medications that are known to impact on mitochondrial function: Corticosteroids, opiates, benzodiazepines, tricyclic antidepressants, beta blockers, sulfonylureas, insulin, anticoagulants, barbiturates, insulin sensitizers, fibrates (PPAR gamma agonist)
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Effect of Aging and Aerobic Exercise Training on Brain Glucose Metabolism
Aging is associated with a loss of brain function and conditions such as dementia and Alzheimer's disease. It is likely that decreased brain metabolism is contributing to the progression of age related degenerative diseases. Aerobic exercise training can increase brain volumes and is associated with decreased risk for degenerative brain conditions. However, little is know about the changes that occur to brain metabolism with aerobic training and aging.
- Conditions
- Dementia
- Being tested
- High intensity aerobic training, Sedentary Control
- Keywords
- High intensity aerobic training
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity aerobic trainingBehavioural
High intensity aerobic interval training will be performed 12-weeks. Exercise training will last 1 hour per day, 5 days per week and include high intensity interval cycling at ~70-95% maximum workload for 4 minutes followed by 3 minutes of rest.
Sedentary ControlBehavioural
Sedentary control participants will not perform any regular exercise for 12-weeks.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Aerobic exercise Receives: Behavioral: High intensity aerobic training; Behavioral: Sedentary Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Brain Glucose Uptake
The investigators will assess brain glucose uptake using positron emission tomography at baseline and following 12-weeks of either aerobic exercise training or sedentary control period.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startOct 2012
- Primary completion12 Feb 2015
- Study completion12 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Val Lowe, Mayo Clinic
- Investigators
- Val Lowe, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738568
- Sponsor's protocol ID
- 12-003357
- Status last verified
- Aug 2021
- First submitted
- 27 Nov 2012
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Robinson MM, Lowe VJ, Nair KS. Increased Brain Glucose Uptake After 12 Weeks of Aerobic High-Intensity Interval Training in Young and Older Adults. J Clin Endocrinol Metab. 2018 Jan 1;103(1):221-227. doi: 10.1210/jc.2017-01571.
PubMed 29077855
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aging and Aerobic Exercise Training on Brain Glucose Metabolism
- ClinicalTrials.gov ID
- NCT01738568
- Acronym / sponsor ID
- 12-003357
- Conditions
- Dementia
- Keywords
- High intensity aerobic training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- 12 Feb 2015 (actual)
- Study completion
- 12 Feb 2015 (actual)
- First posted
- 30 Nov 2012 (estimated)
- 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.
Aging is associated with a loss of brain function and conditions such as dementia and Alzheimer's disease. It is likely that decreased brain metabolism is contributing to the progression of age related degenerative diseases. Aerobic exercise training can increase brain volumes and is associated with decreased risk for degenerative brain conditions. However, little is know about the changes that occur to brain metabolism with aerobic training and aging.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: High intensity aerobic training, Behavioral: Sedentary ControlAerobic exercise |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18-30 years or 65-80 years
Key exclusion criteria (8 listed)
- Body mass index (BMI) >31 kg/m2
- Smoking
- Pregnancy
- Participation in structured exercise (>2 times per week for 30 minutes or longer)
- Cardiovascular, metabolic (type 2 diabetes, fasting plasma glucose at or above 110 mg/dL and untreated hypo- or hyperthyroidism) or renal disease
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 |
|---|---|---|
| High intensity aerobic trainingHigh intensity aerobic interval training will be performed 12-weeks. Exercise training will last 1 hour per day, 5 days per week and include high intensity interval cycling at ~70-95% maximum workload for 4 minutes followed by 3 minutes of rest. | Behavioural | Exercise |
| Sedentary ControlSedentary control participants will not perform any regular exercise for 12-weeks. | Behavioural | Exercise |
Primary outcome
Change in Brain Glucose Uptake
Time frame: 12 weeks
The investigators will assess brain glucose uptake using positron emission tomography at baseline and following 12-weeks of either aerobic exercise training or sedentary control period.
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 30 Aug 2021.
- Derived from this study: PubMed 29077855Robinson MM, Lowe VJ, Nair KS. Increased Brain Glucose Uptake After 12 Weeks of Aerobic High-Intensity Interval Training in Young and Older Adults. J Clin Endocrinol Metab. 2018 Jan 1;103(1):221-227. doi: 10.1210/jc.2017-01571.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Val Lowe, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity aerobic training in people with Dementia, run by Mayo Clinic 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 1 inclusion and 8 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 30 Aug 2021. 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 Glucose Uptake (time frame: 12 weeks). 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 NCT01738568, which also lists 1 linked publication.
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 30 Aug 2021.