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Trial record 1 of 1 for:    NCT03191994
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Impact of an Eight Week Exercise Intervention in Treating Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT03191994
Recruitment Status : Unknown
Verified June 2017 by Bernadette Murphy, University of Ontario Institute of Technology.
Recruitment status was:  Recruiting
First Posted : June 19, 2017
Last Update Posted : June 20, 2017
Information provided by (Responsible Party):
Bernadette Murphy, University of Ontario Institute of Technology

Brief Summary:
To investigate the impact of a structured eight week exercise intervention as an add-on therapy in treating Major Depressive Disorder. Using behavioural techniques and neuroimaging to measure changes in brain function following an exercise intervention in people with clinical depression. By correlating changes in the hippocampus with changes in HPA axis hormones, inflammatory cytokines and growth factors it is possible to determine which of the biochemical markers is most predictive of improved neural function.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Behavioral: Exercise Not Applicable

Detailed Description:

Memory impairment is the most frequently reported cognitive symptom in people with depression. However, research in this area has presented mixed findings in terms of the type, severity and specificity of memory deficits. One finding that has been well established is the impairment in episodic memory (memory for a specific past experience in one's life) with a sparing of semantic memory (present knowledge of universal truths such as "the sky is blue"), and short-term memory. Behavioural and neuroimaging studies investigating the stage of the memory deficit in people with depression have found that both the encoding and retrieval processes are impaired. Although the neural underpinnings of impaired memory in MDD are not completely understood, the majority of evidence implicates abnormal activity in the hippocampal region critical for normal memory formation.

Exercise for depression has been a common research theme for the past several years however its mechanism of action remains unknown. Many studies have reported higher levels of cardiorespiratory fitness and increased habitual physical activity being associated with lower depressive symptomatology and greater emotional well-being, while lower levels of cardiorespiratory fitness being associated with increased risk of developing depressive illness. Exercise alone or in combination with other treatment options, such as pharmacotherapy or cognitive behavioural therapy have all been effective in treating depression with response rates for exercise being comparable to these mainstream therapies. Exercise protects against the development of neurodegenerative diseases delays the negative effects of aging and improves sleep quality. Exercise also reduces inflammation, normalizes cortisol secretion, increases hippocampal neurogenesis, increases cerebrovascular perfusion, improves the structure and function of the hippocampus, facilitates neurocognitive recovery from traumatic brain injury reverses brain volume loss in elderly and schizophrenic individuals and improves learning and memory. These findings suggest that the relationship between fitness and cognition is partly mediated by processes that involve cerebral circulation. These positive effects of exercise on neuroanatomy and vascularization can be partly explained by the interactive cascade of growth factor signalling associated with exercise that increases the ability of cerebral blood vessels to respond to demand. Habitual exercise is an effective way to improve endothelial function by increasing arterial compliance and decreasing arterial stiffness, oxidative stress, and vascular inflammation.

The overall goal of this research study is to investigate the effects of a well-defined, structured, supervised exercise program on brain function in healthy and clinically depressed individuals. This research aims to fill the gaps in the literature by elucidating the anti-depressant mechanisms which exercise targets and if these effects parallel young healthy sedentary individuals.

To investigate the effects of a moderate-intensity structured, supervised 8 week exercise program in people with MDD when combined with a Mental Health Day Treatment (MHDT) program, as compared to the MHDT on its own. All outcome measures will be assessed at baseline and 8 weeks. A non-depressed exercise control group will be used to compare the effects of exercise in depressed and non-depressed individuals:

i. depressive symptoms ii. anxiety iii. sleep quality iv. plasma IL-1β, IL-1ra, IL-6, IFN-γ, TNF-α and IL-10, BDNF v. salivary cortisol vi. performance on an associative memory task and concomitant fMRI hippocampal activation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: MDD exercise group, MDD control group, Healthy exercise group, Healthy control group
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exercise Promotes Neuroplasticity in Depressed and Healthy Brains: An fMRI Pilot Study
Study Start Date : January 2, 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: MDD exercise group
This group will receive eight weeks of moderate exercise in addition to their usual treatment
Behavioral: Exercise
a structured, supervised eight week moderate intensity exercise intervention

No Intervention: MDD control group
This group will receive usual care with no exercise
Experimental: Healthy Exercise
This group will perform an eight week moderate intensity exercise intervention
Behavioral: Exercise
a structured, supervised eight week moderate intensity exercise intervention

No Intervention: Healthy control
This group will not perform exercise

Primary Outcome Measures :
  1. Brain function during an associative memory task [ Time Frame: eight weeks ]
    Participants will be MRI safety screened to ensure no metal implants. Using fMRI to determine brain activity during an associative memory task. Participants will be scanned on a 3-Tesla MR scanner. Scans will be acquired in the oblique coronal plane of the hippocampus. 416 functional scans will be acquired with a T2*-weighted gradient EPI sequence. Preprocessing will be performed using Statistical Parametric Mapping. General linear model will be performed at the single-subject level and statistical contrasts will be created modeling the hemodynamic response function of correct and incorrect responses. Random effects analysis will be performed using the contrast of t-test of correct > incorrect. Significant clusters from an independent samples t-test for correct>incorrect at baseline will be used to extract contrast beta values for correct>incorrect in pre and post scans. Average beta values will be imported into SPSS and a 2 x 2 repeated measures ANOVA (group x time).

Secondary Outcome Measures :
  1. Depression scores [ Time Frame: eight weeks ]
    Depression severity was determined using the self-reported Beck Depression Inventory (BDI). The BDI measures depression severity ranging from mile to severe depression. The higher the score the greater the depression severity.

  2. Biochemical markers [ Time Frame: eight weeks ]
    Peripheral venous blood will be collected from each participant at baseline and eight weeks by venipuncture into ethylenediaminetetraacetic acid (EDTA) tubes. Plasma proteins IL-1β, IL-1Ra, IL-6, IL-10 TNF-α, BDNF and total CTHB will be quantified using enzyme-linked immunosorbant assays (ELISA) following manufacturer's protocols (R&D Systems, MN, USA; BioLegend, CA, USA). Cortisol was measured using participant saliva and quantified using ELISA. Outcome measures will be measured in picograms/ml

  3. Sleep quality [ Time Frame: eight weeks ]
    Sleep quality will be measured using the Pittsburgh Sleep Quality Index a (PSQI) a self reported questionnaire. Sleep quality over the score over 5 is indicative of poor sleep quality.

  4. Anxiety [ Time Frame: eight weeks ]
    Anxiety will be measured using the Hospital Anxiety Depression Scale (HADS) a self-reported questionnaire. The higher the score the greater the anxiety severity.

  5. Memory performance [ Time Frame: eight weeks ]
    Associated memory task using face and names pairs. This was performed during the fMRI. Outcome measures include correct and incorrect reponses

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • all participants must have no contraindications to exercise, be considered 'low active' (exercise less than 3 times per week for less than 20 minutes), MRI safe MDD group must be diagnosed by psychiatrist based on DSM-V criteria and pharmacological medication stabilized for a minimum of 6 weeks

Exclusion Criteria:

  • no immune disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03191994

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Contact: Bernadette Murphy, PhD 905.721.8668 ext 2778 bernadette.murphy@uoit.ca
Contact: Joanne Gourgouvelis, MHSc 905-550-4055 joanne.gourgouvelis@uoit.ca

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Canada, Ontario
University of Ontario Institute of Technology Recruiting
Oshawa, Ontario, Canada, L1H 7K4
Contact: Bernadette Murphy, PhD         
Contact: Joanne Gourgouvelis, PhD    905-550-4055    joanne.gourgouvelis@uoit.ca   
Sub-Investigator: Paul Yielder, PhD         
Sponsors and Collaborators
University of Ontario Institute of Technology
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Principal Investigator: Bernadette Murphy, PhD University of Ontario Institute of Technology

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bernadette Murphy, Professor, University of Ontario Institute of Technology
ClinicalTrials.gov Identifier: NCT03191994    
Other Study ID Numbers: UOntarioIT
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms