NCT02839837

Brief Summary

Depression is associated with a disruption in the mechanisms that regulate neuroplasticity. Effective treatment and rehabilitation of depression, and other neurological and neuropsychiatric disorders, relies on neuroplasticity. Thus, identifying therapies that enhance neuroplasticity (neuroplastic adaptation) are vital in the comprehensive treatment of depression. Aerobic exercise training has been demonstrated to have antidepressant properties and single bouts of aerobic exercise may provide short-term improvements in affective states in depression. Furthermore, acute aerobic exercise may enhance the response to known neuroplasticity-inducing paradigms. However, it is unclear if aerobic exercise can influence neuroplasticity in depression and the neurobiological mechanisms underlying acute neuroplastic changes are not well understood in depressed and healthy cohorts. Thus, the purpose of this project is to examine the acute effects of aerobic exercise on neuroplastic, neurobiological, and mood indices of depression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started May 2016

Typical duration for not_applicable depression

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

Study Start

First participant enrolled

May 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 21, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 30, 2019

Status Verified

January 1, 2019

Enrollment Period

2.6 years

First QC Date

July 12, 2016

Last Update Submit

January 29, 2019

Conditions

Keywords

DepressionDepressive DisorderExerciseNeuroplasticityNon-invasive brain stimulationHealthy Control

Outcome Measures

Primary Outcomes (1)

  • Change in peak to peak MEP amplitude (mV)

    From baseline to one hour post-PAS

Secondary Outcomes (2)

  • Change in serum BDNF (ng/ml)

    From baseline to one hour post-exercise

  • Change in serum cortisol (ng/ml)

    From baseline to one hour post-exercise

Study Arms (1)

Depressed and non-depressed controls

EXPERIMENTAL

All participants will participate in three different conditions: Low intensity aerobic exercise and paired associative stimulation, high intensity aerobic exercise and paired associative stimulation, no exercise control and paired associative stimulation. The order of conditions will be randomized.

Behavioral: Aerobic ExerciseDevice: Paired Associative Stimulation

Interventions

Aerobic exercise will be performed on a stationary cycle ergometer for 15 minutes at an intensity of 35% heart rate reserve or 70% heart rate reserve. During the control condition the participant will remain seated on the stationary cycle for 15 minutes and will not perform exercise.

Depressed and non-depressed controls

After aerobic exercise participants will receive a paired associative stimulation (PAS) paradigm. PAS consists of paired brain and peripheral nerve stimuli. Participants will receive 200 paired stimuli. Peripheral nerve stimulation will be delivered to the median nerve at the level of the wrist via electrical stimulation at 300% perceptual threshold. Brain stimulation will be delivered via transcranial magnetic stimulation (TMS) over the hand knob of the motor cortex at an intensity that elicits a 1mV response in the contralateral abductor pollicis brevis muscle. During each paired stimulation, peripheral nerve stimulation will precede the TMS stimulation by 25ms.

Depressed and non-depressed controls

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • For all:
  • age 18-50 year old.
  • ability to provide informed consent.
  • meets criteria for unipolar depression assessed using the Mini-international Neuropsychiatric Interview (MINI)
  • a Montgomery Asberg Depression Rating Scale (MADRS) score of 20 or greater
  • current depressive episode began no longer than 3 years earlier
  • psychoactive drug free or have maintained a stable dose of up to one antidepressant medication for four weeks prior to study participation
  • does not meet criteria for unipolar depression assessed using the MINI
  • a MADRS score of 6 or less
  • no history or previous diagnosis of depression

You may not qualify if:

  • primary diagnosis of another Axis 1 disorder
  • secondary diagnosis of a psychotic disorder, cognitive disorder, substance-related disorder, or obsessive compulsive disorder
  • illicit drug use or alcohol abuse
  • current smoker
  • history of seizures
  • other diagnosed neurological or musculoskeletal disorder/injury, uncontrolled cardiovascular or metabolic disease
  • resting blood pressure \> 200mmHg systolic or 100mmHg diastolic
  • electronic or metal implants
  • current participation in a structured exercise program
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stroke Recovery Research Center

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

DepressionDepressive DisorderMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Chris Gregory, P.T., Ph.D.

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2016

First Posted

July 21, 2016

Study Start

May 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

January 30, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations