- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02839837
Acute Aerobic Exercise and Neuroplasticity in Depression
The Benefits of Acute Aerobic Exercise on Neuroplastic Potential in Depression
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The investigators will determine the effects of exercising at two different intensities (compared to a control non-exercise condition) on neuroplastic potential in depressed and non-depressed subjects. To accomplish this aim, the investigators will have subjects ride a cycle ergometer at intensities set to elicit 35% (low) and 70% (high) of heart rate reserve (((220 - age) - resting heart rate) x 35% or 70%) + resting heart rate). Prior to, and immediately after exercise participants will have their neuroplastic potential tested via transcranial magnetic stimulation (TMS), blood specimens sampled, and mood changes assessed (methods detailed below). These assessments will occur at these time points and then every 15 minutes for 1 hour after exercise.
Neuroplastic potential will be assessed using TMS. TMS-induced motor evoked potentials (MEP's) will be recorded from the abductor pollicis brevis as a way to measure changes in the excitability of the corticospinal tract in response to exercise and paired associative stimulation. Serum brain-derived neurotrophic factor (BDNF) and cortisol levels will be obtained through blood specimen samples in order to examine the potential exercise-induced changes in known stress- and neuroplasticity-related biomarkers. Mood and affect will be surveyed using the Activation-Deactivation Checklist (AD ACL), feeling scale (FS), and felt arousal scale (FAS). These measures will permit the assessment of exercise-induced changes in mood and affect.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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South Carolina
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Charleston, South Carolina, United States, 29425
- Stroke Recovery Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
For all:
- age 18-50 year old.
- ability to provide informed consent.
Further inclusion criteria for participants with depression:
- 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
Further inclusion criteria for control participants:
- 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
Exclusion Criteria (for all participants):
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Depressed and non-depressed controls
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.
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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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in peak to peak MEP amplitude (mV)
Time Frame: From baseline to one hour post-PAS
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From baseline to one hour post-PAS
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in serum BDNF (ng/ml)
Time Frame: From baseline to one hour post-exercise
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From baseline to one hour post-exercise
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Change in serum cortisol (ng/ml)
Time Frame: From baseline to one hour post-exercise
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From baseline to one hour post-exercise
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Collaborators and Investigators
Investigators
- Principal Investigator: Chris Gregory, P.T., Ph.D., Medical University of South Carolina
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro#00050872
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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