Cognition and Neuroplasticity Sedentary Adults After 8 Weeks of Aerobic Exercise

Sponsor

University of Miami (Other)

Overall Status

Completed

CT.gov ID

NCT03804528

Collaborator

(none)

Enrollment

Location

Arm

26.7

Actual Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sedentary Behavior	Behavioral: Aerobic Exercise	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

75 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

The intervention group will perform 4-weeks of moderate intensity exercise followed by 4-weeks of high intensity aerobic exercise.The intervention group will perform 4-weeks of moderate intensity exercise followed by 4-weeks of high intensity aerobic exercise.

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Mar 8, 2019

Actual Primary Completion Date :

May 28, 2021

Actual Study Completion Date :

May 28, 2021

Arms and Interventions

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).	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.

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).

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.

Outcome Measures

Primary Outcome Measures

Change in TMS Plasticity Measures [baseline and after 8 weeks of exercise]
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.
Change in Cognitive Performance [baseline and after 8 weeks of exercise]
Cognitive performance will be assessed using a neuropsychological test battery in executive function, processing speed, learning, and language.

Secondary Outcome Measures

Changes in BDNF Levels [baseline and after 8 weeks of exercise]
Blood samples will be collected for BDNF levels.
Change in Aerobic Capacity (Cardiovascular Fitness) [baseline and after 8 weeks of exercise]
A maximal treadmill test will be performed to determine maximal oxygen uptake (VO2) as a measure of aerobic capacity.
Allelic Status BDNF [baseline]
Genetic testing will be performed to assess for brain-derived neurotrophic factor (BDNF) Val66Met polymorphism.
Allelic Status APOE [baseline]
Genetic testing will be performed to assess for the presence of apolipoprotein-E (APOE) e4 allele.

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami Miller School of Medicine	Miami	Florida	United States	33136

Sponsors and Collaborators

University of Miami

Investigators

Principal Investigator: Joyce R Gomes-Osman, PT, PhD, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Joyce Rios Gomes Osman, Assistant Professor, University of Miami

ClinicalTrials.gov Identifier:

NCT03804528

Other Study ID Numbers:

20180926

First Posted:

Jan 15, 2019

Last Update Posted:

Jun 2, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 2, 2021