NCT02994134

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 15, 2016

Completed
10 months until next milestone

Study Start

First participant enrolled

September 29, 2017

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

December 8, 2021

Status Verified

November 1, 2021

Enrollment Period

3.3 years

First QC Date

December 1, 2016

Last Update Submit

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 COMPARATOR

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.

High intensity exercise

EXPERIMENTAL

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.

Interventions

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

Moderate intensity exercise.

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

High intensity exercise

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Sedentary Behavior

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Joyce R Gomes Osman, PT, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

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

Locations