Clinical trial NCT02994134: Exercise, Cognitive Function and Neuroplasticity in Healthy Adults
Official title: Exercise, Cognitive Function and Neuroplasticity in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Lifestyle
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2016-12-15
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in cortical synaptic plasticity using transcranial magnetic stimulation (TMS) from baseline to post-exercise.
timeFrame: Baseline, 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
Study officials:
affiliation: University of Miami
name: Joyce R Gomes Osman, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: