Exercise, Cognitive Function and Neuroplasticity in Healthy Adults

Sponsor
University of Miami (Other)
Overall Status
Completed
CT.gov ID
NCT02994134
Collaborator
(none)
19
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Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Moderate intensity exercise.
  • Behavioral: High intensity exercise.
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Exercise, Cognitive Function and Neuroplasticity in Healthy Adults
Actual Study Start Date :
Sep 29, 2017
Actual Primary Completion Date :
Jan 21, 2021
Actual Study Completion Date :
Oct 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Moderate intensity exercise.

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

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

Experimental: High intensity exercise

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

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.

Outcome Measures

Primary Outcome Measures

  1. Change in cortical synaptic plasticity using transcranial magnetic stimulation (TMS) from baseline to post-exercise. [Baseline, 4 weeks]

    Plasticity with TMS

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

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:
NCT02994134
Other Study ID Numbers:
  • 20161059
First Posted:
Dec 15, 2016
Last Update Posted:
Dec 8, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Dec 8, 2021