Exercise, Cognitive Function and Neuroplasticity in Healthy Adults

NCT ID: NCT02994134

Last Updated: 2021-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-29

Study Completion Date

2021-10-31

Brief Summary

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The overall goal of the proposed study is to compare the effects of 4 weeks of moderate or high intensity aerobic exercise on neuroplasticity, cognitive performance and gait and postural control in sedentary healthy adults.

Detailed Description

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The primary aim of the study is to compare the effects of a moderate intensity aerobic exercise intervention (delivered at 55-64% age-predicted maximal heart rate) with a high intensity aerobic exercise intervention (delivered at 65%-90% age-predicted maximal heart rate) on measures that probe cortical synaptic plasticity using transcranial magnetic stimulation (TMS) in sedentary healthy adults.

Conditions

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Sedentary Lifestyle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Moderate intensity exercise.

Moderate intensity aerobic exercise intervention (delivered at 55-64% age-predicted maximal heart rate), 4 times per week for 4 weeks.

Group Type ACTIVE_COMPARATOR

Moderate intensity exercise.

Intervention Type BEHAVIORAL

Moderate intensity aerobic exercise intervention (delivered at 55-64% age-predicted maximal heart rate), 4 times per week for 4 weeks.

High intensity exercise

High intensity aerobic exercise intervention (delivered at 65%-90% age-predicted maximal heart rate), 4 times per week for 4 weeks.

Group Type EXPERIMENTAL

High intensity exercise.

Intervention Type BEHAVIORAL

High intensity aerobic exercise intervention (delivered at 65-90% age-predicted maximal heart rate), 4 times per week for 4 weeks.

Interventions

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Moderate intensity exercise.

Moderate intensity aerobic exercise intervention (delivered at 55-64% age-predicted maximal heart rate), 4 times per week for 4 weeks.

Intervention Type BEHAVIORAL

High intensity exercise.

High intensity aerobic exercise intervention (delivered at 65-90% age-predicted maximal heart rate), 4 times per week for 4 weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Adult males and females aged 18-70 years old
* Primary language is English
* Sedentary (defined as not engaging in purposeful physical activity more than 2 times over the last two months)
* Exercise clearance

Exclusion Criteria

* Presence of cognitive, neurologic or orthopedic conditions that could affect performance of the testing and training procedures
* History of migraines.
* 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
* Any unstable medical condition
* 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 CNS active drugs.
* The published TMS guidelines review medications to be considered with TMS (Rossi, Hallett, Rossini, Pascual-Leone, \& Safety of TMS Consensus Group, 2009).
* 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 Subjects who, in the Investigator's opinion, might not be suitable for the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Joyce Rios Gomes Osman

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joyce R Gomes Osman, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami Miller School of Medicine

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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20161059

Identifier Type: -

Identifier Source: org_study_id