Cognition and Neuroplasticity Sedentary Adults After 8 Weeks of Aerobic Exercise

Not Applicable

Completed

• Conditions: Sedentary Behavior
• Interventions: Behavioral: Aerobic Exercise

• Registration Number: NCT03804528
• Lead Sponsor: University of Miami

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. The investigators will also explore the effect modification of BDNF levels and BDNF allelic status, and APOE4 status on cognitive response after exercise.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-12-11
• Study First Submitted QC: 2019-01-14
• Study First Posted: 2019-01-15
• Study Start: 2019-03-08
• Primary Completion: 2021-05-28
• Study Completion: 2021-05-28
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-29
• Last Update Posted: 2022-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exercise group (All participants)	Aerobic Exercise	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.

Primary Outcome Measures

Name	Time	Method
Change in TMS Plasticity Measures	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)	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)	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)	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 Outcome Measures

Name	Time	Method
Circulating Markers of Endothelium Function (BDNF)	Baseline	Blood samples will be collected to measure: brain-derived neurotrophic factor (BDNF) levels (measured as pg/mL).
Change in Cardiorespiratory Fitness	Baseline and Post-intervention (after 8 weeks of exercise)	Heart rate recovery (HRR) is the primary measure for cardiorespiratory fitness. HRR is defined as the change in the heart rate from the peak of exercise to the heart rate after 1-min (HRR-1) and 2-min test cessation (HRR-2).
Circulating Markers of Endothelium Function (VEGF)	Baseline	Blood samples will be collected to measure vascular endothelial growth factor (VEGF) (measured as pg/mL).
Circulating Markers of Endothelium Function (Hs-CRP)	Baseline	Blood samples will be collected to measure high sensitivity C reactive protein (HS-CRP) (measured as mg/L).

Trial Locations

Locations (1)

University of Miami Miller School of Medicine; 🇺🇸 Miami, Florida, United States