Cognition and Neuroplasticity Sedentary Adults After 8 Weeks of Aerobic Exercise

Sedentary Behavior Clinical Trial

Official title:

Assessing Cognitive Improvements, Brain Neuroplasticity and the Role of Genetic Factors After Aerobic Exercise in Sedentary Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03804528
• Other study ID #: 20180926
• Status: Completed
• Phase: N/A
• Start date: March 8, 2019
• Est. completion date: May 28, 2021

Study information

• Verified date: August 2022
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 28, 2021
• Est. primary completion date: May 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sedentary Behavior

Intervention

Behavioral:
• Aerobic Exercise
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.

Locations

Country	Name	City	State
United States	University of Miami Miller School of Medicine	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in TMS Plasticity Measures	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.	baseline and after 8 weeks of exercise
Primary	Change in Cognitive Performance	Cognitive performance will be assessed using a neuropsychological test battery in executive function, processing speed, learning, and language.	baseline and after 8 weeks of exercise
Secondary	Changes in BDNF Levels	Blood samples will be collected for BDNF levels.	baseline and after 8 weeks of exercise
Secondary	Change in Aerobic Capacity (Cardiovascular Fitness)	A maximal treadmill test will be performed to determine maximal oxygen uptake (VO2) as a measure of aerobic capacity.	baseline and after 8 weeks of exercise
Secondary	Allelic Status BDNF	Genetic testing will be performed to assess for brain-derived neurotrophic factor (BDNF) Val66Met polymorphism.	baseline
Secondary	Allelic Status APOE	Genetic testing will be performed to assess for the presence of apolipoprotein-E (APOE) e4 allele.	baseline