DepressionNCT02839837
Acute Aerobic Exercise and Neuroplasticity in Depression
A study testing Aerobic Exercise and Paired Associative Stimulation in people with Depression and Depressive Disorder, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Depressive Disorder
- What is being tested?
- Aerobic Exercise and Paired Associative Stimulation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- resting blood pressure > 200mmHg systolic or 100mmHg diastolic
- electronic or metal implants
- current participation in a structured exercise program
- pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Stroke Recovery Research Center
Charleston, South Carolina, 29425
About this study
Official title: The Benefits of Acute Aerobic Exercise on Neuroplastic Potential in Depression
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.
Read the 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.
- Conditions
- Depression, Depressive Disorder
- Being tested
- Aerobic Exercise, Paired Associative Stimulation
- Keywords
- Depression, Depressive Disorder, Exercise, Neuroplasticity, Non-invasive brain stimulation, Healthy Control
- Medical subject headings
- Depression, Depressive Disorder, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseBehavioural
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.
Paired Associative StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Aerobic Exercise; Device: Paired Associative Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peak to peak MEP amplitude (mV)
Measured: From baseline to one hour post-PAS
Secondary outcomes (2)
Change in serum BDNF (ng/ml)
Measured: From baseline to one hour post-exercise
Change in serum cortisol (ng/ml)
Measured: From baseline to one hour post-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chris Gregory, P.T., Ph.D., Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839837
- Sponsor's protocol ID
- Pro#00050872
- Status last verified
- Jan 2019
- First submitted
- 12 Jul 2016
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Benefits of Acute Aerobic Exercise on Neuroplastic Potential in Depression
- ClinicalTrials.gov ID
- NCT02839837
- Acronym / sponsor ID
- Pro#00050872
- Conditions
- Depression, Depressive Disorder
- Keywords
- Depression, Depressive Disorder, Exercise, Neuroplasticity, Non-invasive brain stimulation, Healthy Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 21 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Depressed and non-depressed controls | Experimental | Behavioral: Aerobic Exercise, Device: Paired Associative StimulationAll 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic ExerciseAerobic 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. | Behavioural | Depressed and non-depressed controls |
| Paired Associative StimulationAfter 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. | Device | Depressed and non-depressed controls |
Primary outcome
Change in peak to peak MEP amplitude (mV)
Time frame: From baseline to one hour post-PAS
2 secondary outcomes
Change in serum BDNF (ng/ml)
Time frame: From baseline to one hour post-exercise
Change in serum cortisol (ng/ml)
Time frame: From baseline to one hour post-exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Gregory, P.T., Ph.D. principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise and Paired Associative Stimulation in people with Depression and Depressive Disorder, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in peak to peak MEP amplitude (mV) (time frame: From baseline to one hour post-PAS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2019.