- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03804528
Cognition and Neuroplasticity Sedentary Adults After 8 Weeks of Aerobic Exercise
August 29, 2022 updated by: Joyce Rios Gomes Osman, University of Miami
Assessing Cognitive Improvements, Brain Neuroplasticity and the Role of Genetic Factors After Aerobic Exercise in Sedentary Adults
The overall goal of the proposed study is to evaluate the effects of an 8-week aerobic exercise program on cognition and determine the relationship between cognitive improvements and Transcranial Magnetic Stimulation (TMS) neuroplasticity.
The investigators will also explore the effect modification of BDNF levels and BDNF allelic status, and APOE4 status on cognitive response after exercise.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The investigators will quantify cognitive improvements following moderate to high intensity aerobic exercise intervention (participant will choose between treadmill, elliptical or stationary bike).
Each participant will engage in 60 minute daily sessions delivered 3 times/week for 8 consecutive weeks (a total of 24 sessions).
The investigators will determine the relationship between cognitive improvements and TMS neuroplasticity.
The cognitive domains explored will be: 1) Visuomotor processing speed and cognitive flexibility/task switching; 2) Response inhibition, mental flexibility, and attentional control; 3) Attention and working memory; 4) List Learning and Memory; and 5) Semantic Verbal Fluency.
The investigators will also explore the effect modification of BDNF levels and BDNF allelic status, and APOE4 status on cognitive response after exercise.
Study Type
Interventional
Enrollment (Actual)
75
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Florida
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Miami, Florida, United States, 33136
- University of Miami Miller School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age ≥ 55years
- no clinically detectable cognitive impairment (MoCA score ≥ 24 and Clinical Dementia Rating (CDR) score of 0)
- low activity level (individuals who do not engage in regular exercise, or currently exercise once a week or less)
- primary language is English
Exclusion Criteria:
- any unstable medical condition (i.e.: uncontrolled hypertension or uncontrolled diabetes)
- medical contraindication to physical exercise
- contraindication to TMS Neuroplasticity testing, as per the TMS Safety Guidelines.
- History of fainting spells of unknown or undetermined etiology that might constitute seizures
- History of seizures, diagnosis of epilepsy, history of abnormal (epileptiform) EEG or family history of treatment resistant epilepsy
- Any current history of a psychiatric illness
- No medication is an absolute exclusion from TMS. Medications will be reviewed by the Principal Investigator and a decision about inclusion will be made based on the following:
- The subject's past medical history, drug dose, history of recent medication changes or duration of treatment, and combination with other Central Nervous System (CNS) active drugs.
- The published TMS guidelines review medications to be considered with TMS.
- Any metal in the brain, skull or elsewhere unless approved by the responsible MD
- Any medical devices (i.e. Cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant, vagal nerve stimulator)
- Intracranial lesion
- Substance abuse or dependence within the past six months
- Pregnant women
- Vulnerable populations such as prisoner's
- People unable to consent themselves
- Subjects who, in the Investigator's opinion might not be suitable for the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise group
Each participant will engage in 60 minute daily sessions delivered 3 times/week for 8 consecutive weeks (a total of 24 sessions).
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Participants will be fitted with a heart rate monitor and will be instructed to walk (or trot) to maintain 55-64% of maximal heart rate (determined by exercise test) for the first 4-weeks of exercise or to maintain 65-90% of maximal heart rate (determined by exercise test) for the second 4-weeks of exercise during each session.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in TMS Plasticity Measures
Time Frame: baseline and after 8 weeks of exercise
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An index of the duration of the Theta-Burst Stimulation (TBS) induced modulation of corticospinal excitability (the time-point at which the normalized mean Motor Evoked Potential (MEP) amplitude returns to baseline values) will be defined for each participant.
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baseline and after 8 weeks of exercise
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Change in Cognitive Performance
Time Frame: baseline and after 8 weeks of exercise
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Cognitive performance will be assessed using a neuropsychological test battery in executive function, processing speed, learning, and language.
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baseline and after 8 weeks of exercise
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in BDNF Levels
Time Frame: baseline and after 8 weeks of exercise
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Blood samples will be collected for BDNF levels.
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baseline and after 8 weeks of exercise
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Change in Aerobic Capacity (Cardiovascular Fitness)
Time Frame: baseline and after 8 weeks of exercise
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A maximal treadmill test will be performed to determine maximal oxygen uptake (VO2) as a measure of aerobic capacity.
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baseline and after 8 weeks of exercise
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Allelic Status BDNF
Time Frame: baseline
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Genetic testing will be performed to assess for brain-derived neurotrophic factor (BDNF) Val66Met polymorphism.
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baseline
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Allelic Status APOE
Time Frame: baseline
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Genetic testing will be performed to assess for the presence of apolipoprotein-E (APOE) e4 allele.
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baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joyce R Gomes-Osman, PT, PhD, University of Miami
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 8, 2019
Primary Completion (Actual)
May 28, 2021
Study Completion (Actual)
May 28, 2021
Study Registration Dates
First Submitted
December 11, 2018
First Submitted That Met QC Criteria
January 14, 2019
First Posted (Actual)
January 15, 2019
Study Record Updates
Last Update Posted (Actual)
August 30, 2022
Last Update Submitted That Met QC Criteria
August 29, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 20180926
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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