Exercise, Cognitive Function and Neuroplasticity in Healthy Adults
1 other identifier
interventional
19
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2016
CompletedFirst Posted
Study publicly available on registry
December 15, 2016
CompletedStudy Start
First participant enrolled
September 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 21, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2021
CompletedDecember 8, 2021
November 1, 2021
3.3 years
December 1, 2016
November 24, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change in cortical synaptic plasticity using transcranial magnetic stimulation (TMS) from baseline to post-exercise.
Plasticity with TMS
Baseline, 4 weeks
Study Arms (2)
Moderate intensity exercise.
ACTIVE COMPARATORModerate intensity aerobic exercise intervention (delivered at 55-64% age-predicted maximal heart rate), 4 times per week for 4 weeks.
High intensity exercise
EXPERIMENTALHigh intensity aerobic exercise intervention (delivered at 65%-90% age-predicted maximal heart rate), 4 times per week for 4 weeks.
Interventions
Moderate intensity aerobic exercise intervention (delivered at 55-64% age-predicted maximal heart rate), 4 times per week for 4 weeks.
High intensity aerobic exercise intervention (delivered at 65-90% age-predicted maximal heart rate), 4 times per week for 4 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Miami Miller School of Medicine
Miami, Florida, 33136, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joyce R Gomes Osman, PT, PhD
University of Miami
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
December 1, 2016
First Posted
December 15, 2016
Study Start
September 29, 2017
Primary Completion
January 21, 2021
Study Completion
October 31, 2021
Last Updated
December 8, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share