AgingACENCT03750903
Effect of Aging on Cortical Excitability and Motor Learning
A study testing Aerobic Exercise and Stretching and Balance Training in people with Aging, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The objective of the current proposal is to identify 1) how aging-related changes in GABAergic cortical inhibition affect motor performance, and 2) how aerobic exercise may improve inhibitory function and facilitate motor learning. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Aerobic Exercise and Stretching and Balance Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2019to 30 Sep 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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- living persons aged 50-85
Who cannot join
- unmanaged diabetes
- participants completing vigorous exercise per week
- participants whose profession requires vigorous physical labor
- contraindication to magnetic resonance imaging
Trial locations and contacts
1 site in 1 country.
United States1 site
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Washington, 30033-4004
About this study
Official title: Effects of Aging on Cortical Excitability During Motor Learning
The objective of the current proposal is to identify 1) how aging-related changes in GABAergic cortical inhibition affect motor performance, and 2) how aerobic exercise may improve inhibitory function and facilitate motor learning.
Read the detailed description
The current proposal seeks quantify neural inhibition using magnetic resonance spectroscopy (MRS) and transcranial magnetic stimulation (TMS) in older Veterans to identify how each measures contributes to aging-related changes in motor performance. Currently, over 56% (11.8 million) of Veterans are over age 60. Recent research has shown that aging is associated with decreased cortical inhibition and impaired hand motor function. However, this loss of inhibition is not an inescapable consequence of aging. The investigators' previous work that healthy older adults who engage in regular physical activity show increased cortical inhibition and improved dexterity as compared to their sedentary age cohort. This indicates that aerobic training may reverse aging related changes in cortical inhibition and alteration of tonic levels of cortical excitability can have a powerful impact on motor performance in the aging brain. In the current proposal, the investigators will enroll older adults to assess how different measurements (TMS and MRS) of the dominant inhibitory neurotransmitter in the brain - GABA differ in relation to motor control. During the MRS scan, participants will perform a motor learning task to assess change in GABA level throughout the acquisition session. These data will be compared with measures of cortical inhibition using TMS to quantify neurotransmitter receptor activity with respect to aging-related changes in motor performance. The investigators will also be comparing the effects of an aerobic exercise intervention as compared to a contact matched stretching control. The investigators believe this project is the first inquiry of its kind and will have an important impact in the understanding of aging-related neurophysiological changes in the brain and how it can remediate associated behavioral declines.
- Conditions
- Aging
- Being tested
- Aerobic Exercise, Stretching and Balance Training
- Keywords
- aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseBehavioural
Also called AE; Exercise
Participants will engage in an aerobic exercise program meeting thrice weekly for a period of 12 weeks.
Stretching and Balance TrainingBehavioural
Also called BAL; Balance
Participants will engage in a balance and stretching comparator condition meeting thrice weekly for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise | Experimental | Participants will engage in an aerobic exercise program meeting thrice weekly for a period of 12 weeks. Receives: Behavioral: Aerobic Exercise |
| Stretching and Balance Training | Active comparator | Participants will engage in a balance and stretching comparator condition meeting thrice weekly for 12 weeks. Receives: Behavioral: Stretching and Balance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnetic Resonance Spectroscopy
Measuring changes in dynamic magnetic resonance spectroscopy of primary motor cortex during motor learning.
Measured: Baseline and12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start4 Mar 2019
- Primary completion30 Sep 2023
- Study completion30 Sep 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 AgingStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Two group parallel design
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Joe R. Nocera, PhD, Principal investigator, Atlanta VA Medical and Rehab Center, Decatur, GA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750903
- Sponsor's protocol ID
- E2619-R
- Acronym
- ACE
- Status last verified
- Apr 2025
- First submitted
- 20 Nov 2018
- Last updated
- 3 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aging on Cortical Excitability During Motor Learning
- ClinicalTrials.gov ID
- NCT03750903
- Acronym / sponsor ID
- ACE / E2619-R
- Conditions
- Aging
- Keywords
- aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 23 Nov 2018 (actual)
- Results
- Posted 3 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the current proposal is to identify 1) how aging-related changes in GABAergic cortical inhibition affect motor performance, and 2) how aerobic exercise may improve inhibitory function and facilitate motor learning.
Detailed description
The current proposal seeks quantify neural inhibition using magnetic resonance spectroscopy (MRS) and transcranial magnetic stimulation (TMS) in older Veterans to identify how each measures contributes to aging-related changes in motor performance. Currently, over 56% (11.8 million) of Veterans are over age 60. Recent research has shown that aging is associated with decreased cortical inhibition and impaired hand motor function. However, this loss of inhibition is not an inescapable consequence of aging. The investigators' previous work that healthy older adults who engage in regular physical activity show increased cortical inhibition and improved dexterity as compared to their sedentary age cohort. This indicates that aerobic training may reverse aging related changes in cortical inhibition and alteration of tonic levels of cortical excitability can have a powerful impact on motor performance in the aging brain. In the current proposal, the investigators will enroll older adults to assess how different measurements (TMS and MRS) of the dominant inhibitory neurotransmitter in the brain - GABA differ in relation to motor control. During the MRS scan, participants will perform a motor learning task to assess change in GABA level throughout the acquisition session. These data will be compared with measures of cortical inhibition using TMS to quantify neurotransmitter receptor activity with respect to aging-related changes in motor performance. The investigators will also be comparing the effects of an aerobic exercise intervention as compared to a contact matched stretching control. The investigators believe this project is the first inquiry of its kind and will have an important impact in the understanding of aging-related neurophysiological changes in the brain and how it can remediate associated behavioral declines.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two group parallel design
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise | Experimental | Behavioral: Aerobic ExerciseParticipants will engage in an aerobic exercise program meeting thrice weekly for a period of 12 weeks. |
| Stretching and Balance Training | Active comparator | Behavioral: Stretching and Balance TrainingParticipants will engage in a balance and stretching comparator condition meeting thrice weekly for 12 weeks. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- living persons aged 50-85
Key exclusion criteria (4 listed)
- unmanaged diabetes
- participants completing vigorous exercise per week
- participants whose profession requires vigorous physical labor
- contraindication to magnetic resonance imaging
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 ExerciseAlso: AE; ExerciseParticipants will engage in an aerobic exercise program meeting thrice weekly for a period of 12 weeks. | Behavioural | Aerobic Exercise |
| Stretching and Balance TrainingAlso: BAL; BalanceParticipants will engage in a balance and stretching comparator condition meeting thrice weekly for 12 weeks. | Behavioural | Stretching and Balance Training |
Primary outcome
Magnetic Resonance Spectroscopy
Time frame: Baseline and12 weeks
Measuring changes in dynamic magnetic resonance spectroscopy of primary motor cortex during motor learning.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Joe R. Nocera, PhD principal investigator
Atlanta VA Medical and Rehab Center, Decatur, GA
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 and Balance Training in people with Aging, run by VA Office of Research and Development 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 4 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 3 Apr 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 3 Apr 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?
Magnetic Resonance Spectroscopy (time frame: Baseline and12 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 3 Apr 2025.