Assessing Cognitive Improvements, Brain Neuroplasticity and the Role of Genetic Factors After Aerobic Exercise in Sedentary Adults
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of Miami
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Change in TMS Plasticity Measures
Study Overview
Brief Summary
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.
Detailed Description
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 neuroplasticity. The primary study aims include: 1) Quantify improvements in cognitive performance after 8 weeks (150 min per week) of moderate intensity aerobic exercise in sedentary adults ≥ 55 years of age; 2) Determine an association between changes in plasticity, aerobic capacity, and cognitive performance overall and by cognitive domain, after 8 weeks of moderate intensity aerobic exercise in sedentary adults ≥ 55 years of age.
Due to challenges posed by the COVID-19 pandemic, social distancing practices, and aiming to create a feasible scenario to continue the current study, we propose an additional option to safely adapt study methods to deliver the study in a home-based, fully remote manner. Importantly, this scenario also presents as an opportunity to collect meaningful data on our specific aims while translating this successful research program into a remote/home-based mode of delivery. A remote/home based option may also yield valuable preliminary data that will be relevant for planning future exercise studies in aging adults in the present "new normal". Therefore, this research project consist of two equivalent options:
Option A: Current, IRB-approved, in-person methods pending appropriateness based on current University of Miami recommendations and standard operating procedures as it relates to the COVID-19 pandemic.
Option B: Remote option of current methods to maximize recruitment. This will be the only option until the study team obtains approval to resume Option A (as per University's safety guidelines).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 55 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Exercise group (All participants)
Each participant will engage in 60 minute in-person daily sessions delivered 3 times/week for 8 consecutive weeks (a total of 24 sessions). Participants were provided with option to participate remotely due to COVID-19 pandemic.
Intervention: Aerobic Exercise (Behavioral)
Outcomes
Primary Outcomes
Change in TMS Plasticity Measures
Time Frame: Baseline and Post-intervention (after 8 weeks of exercise)
Index of the duration of the Theta-burst stimulation (TBS)-induced modulation of corticospinal excitability. This outcome measure refers to the identification of the time point (T5, T10, T15, T20 and T30). at which the normalized motor evoked potential (MEP) amplitude returns to baseline values (T0 or Baseline). This measure will be in Minutes Post Theta-Burst stimulation. This is a neurophysiological measure, and no group-based norms apply.
Cognitive Performance (RBANS)
Time Frame: Baseline and Post-intervention (after 8 weeks of exercise)
Cognitive performance will be assessed using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) a neuropsychological test battery in executive function, processing speed, learning, and language. It is made up of a series of twelve subtests that take approximately 30 minutes. For each of these, a lower number correct is indicative of a higher cognitive deficit. Subtests are their scales are: RBANS Semantic Fluency (0-unlimited), RBANS Picture Naming (0-10), RBANS List Learning (0-40), RBANS List Recall (0-10), RBANS Story Memory (0-24), RBANS Story Recall (0-12), RBANS List Recognition (0-20), RBANS Digit Span (0-16), RBANS Figure Recall (0-20), RBANS Coding (0-89), RBANS Figure Copy (0-20), RBANS Line Orientation (0-20).
Cognitive Performance (DKEFS)
Time Frame: Baseline and Post-intervention (after 8 weeks of exercise)
Cognitive performance will be assessed using a neuropsychological test battery in executive function, processing speed, learning, and language. The D-KEFS Verbal Fluency Test measures the ability to generate words fluently in an effortful phonemic format (letter fluency),from overlearned concepts (category fluency), and simultaneously shifting between overlearned concepts (category switching). Raw scores (correct responses, correct number of switches between categories) are converted to scaled scores with a mean of 10 and a standard deviation of 3. Higher scores reflect higher verbal fluency, and an increase in score pre-post would indicate improvement.
Cognitive Performance (Digital Span)
Time Frame: Baseline and Post-intervention (after 8 weeks of exercise)
Digital span - Subtest of the Wechsler Adult Intelligence Scale fourth edition; Three sections: Digits Forward, Digits Backward, and Digits Sequencing. For each section, min. raw score value: 0; max. raw score value: 16. Higher the score, better the outcome.
Secondary Outcomes
- Circulating Markers of Endothelium Function (BDNF)(Baseline)
- Change in Cardiorespiratory Fitness(Baseline and Post-intervention (after 8 weeks of exercise))
- Circulating Markers of Endothelium Function (VEGF)(Baseline)
- Circulating Markers of Endothelium Function (Hs-CRP)(Baseline)
Investigators
Joyce Rios Gomes Osman
Assistant Professor
University of Miami