Exercise, Cognitive Function and Neuroplasticity in Healthy Adults

Sedentary Lifestyle Clinical Trial

Official title:

Exercise, Cognitive Function and Neuroplasticity in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02994134
• Other study ID #: 20161059
• Status: Completed
• Phase: N/A
• Start date: September 29, 2017
• Est. completion date: October 31, 2021

Study information

• Verified date: November 2021
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: October 31, 2021
• Est. primary completion date: January 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Sedentary Lifestyle

Intervention

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

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 cortical synaptic plasticity using transcranial magnetic stimulation (TMS) from baseline to post-exercise.	Plasticity with TMS	Baseline, 4 weeks