An interventional study of Aerobic Exercise in Depressive Disorder, Major, sponsored by University College Cork. Recruiting at 1 site in Ireland. Open to participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2024-11-08.
Sponsored by University College Cork · Not applicable, Interventional, and Basic science
This study aims to investigate the effects of a 12-week aerobic (cardio) exercise intervention in people with Major Depressive Disorder.
Measurements taken before, during, and following the 12-week intervention will include assessments of cognition, cardiorespiratory fitness, stress, mood and emotion, and gut bacteria.
Major depressive disorder (MDD) affects 10% of people globally. Additionally, approximately only half of individuals respond to current psychotherapy treatments, with approximately 30% of individuals classed as treatment resistant to psychopharmacological treatments. Despite the current variety in treatments, the gap in efficacy of current treatments means it is imperative to develop a deeper understanding of MDD, so additional treatment options are available to help those whose current treatment is ineffective. Apart from psychotherapies or combined psychopharmacotherapies, exercise may be beneficial for individuals with MDD.
The microbiota-gut-brain-axis has been implicated in MDD, with gut bacteria relative abundance differences observed between individuals with MDD and healthy controls. Exercise interventions can reduce depressive symptoms in individuals with mild-moderate MDD and may be beneficial to people alongside standard care. Physical activity is also capable of modulating the gut microbiome. However, it remains an open question if lifestyle interventions such as exercise may act through the microbiome to enact positive outcomes in individuals with MDD.
As depression does not affect brain function exclusively, but manifests as a whole-body disorder, the investigators propose that depression is, in part, a disorder of the microbiome-gut-brain-axis. Given that the gut microbiome is capable of driving stress and immune alterations that regulate dysfunctional brain circuitry, contributing to depressive symptomology, including cognitive dysfunction and negative biases. Therefore, the current project will be the first to assess the gut microbiome in MDD, whilst undergoing an exercise intervention in conjunction with monitoring dietary intakes.
To achieve this, a RCT will be conducted with two groups of adults with MDD randomized to either a control (usual/standard care) or exercise intervention (aerobic exercise + usual/standard care). The intervention period will last 12-weeks, with those in the exercise group receiving an aerobic exercise program tailored via progressive overload to get them to meet, and then exceed the national physical activity guidelines (>150min of moderate activity per week) by the 12-week mark. Each group will be assessed pre-, mid-, and post-intervention for depressive symptoms, cognition, negative biases, along with diet information, with mechanistic insights gained from evaluation of gut microbiome composition and function, and gut metabolites in the context of microbiota-gut-brain axis signaling.
Prior to enrollment, participants will be informed about the study via a participant information leaflet, and any participant who provides written informed consent to their participation in the study, will then be screened for eligibility and enrolled if eligible.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's planned enrollment of 40 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →University College Cork is the lead sponsor of 116 studies on the registry; 23 are open to participants now.
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Exclusion Criteria:
Participants allocated to usual care study arm, will continue with their current treatment plan as at study enrollment. This includes any pharmacological treatment they may be receiving, as well as any psychological treatment (i.e., therapy sessions with psychiatrist, psychologist etc.). Participants in usual care group will have the same number of study visits (4 total) across a 12-week period, as the aerobic exercise group.
Participants allocated to aerobic exercise study arm, will engage in aerobic exercise for 12-weeks. This will occur alongside participants usual care, as determined at study enrollment, including any pharmacological treatment they may be receiving, as well as any psychological treatment (i.e., therapy sessions with psychiatrist, psychologist etc.). Participants in aerobic exercise group will have the same number of study visits (4 total) across a 12-week period, as the usual care group.
Behavioral: Aerobic Exercise
Aerobic exercise intervention will involve multiple exercise sessions completed (unsupervised) by participants. Exercise programs will be given to participants, matched to their current level of fitness as determined via a maximal cardiorespiratory fitness test, and will be adjusted via progressive overload every 1-2 weeks by an exercise and sports science professional.
Also known as: exercise, cardio, cardiorespiratory exercise
Depression symptom change
Depression symptoms measured via self-report questionnaire (Beck's Depression Inventory-II).
Time frame: Change from baseline at 12-weeks
Negative and positive affect change
Negative and positive affect, measured via self-report positive affect negative affect schedule.
Time frame: Change from baseline at 12-weeks
Gut microbiota change
Gut microbiota, measured via sequencing of stool samples (including measures of diversity, composition, and function).
Time frame: Change from baseline at 12-weeks
Cognitive performance: affective perceptual bias
Emotional bias, measured via Emotional bias task via CANTAB.
Time frame: Change from baseline at 12-weeks
Cognitive performance: social cognition
Emotional recognition, measured via Emotional recognition task via CANTAB.
Time frame: Change from baseline at 12-weeks
Cardiorespiratory fitness change
Cardiorespiratory fitness, measured via VO2max test.
Time frame: Change from baseline at 12-weeks
Cognitive performance: Psychomotor function
Reaction time, simple and multi-choice measured via CANTAB.
Time frame: Change from baseline at 12-weeks
Cognitive performance: Attention
Rapid Visual Information Processing, measured via CANTAB.
Time frame: Change from baseline at 12-weeks
Cognitive performance: Executive Function
Measured via One Touch stockings of Cambridge task, in CANTAB
Time frame: Change from baseline at 12-weeks
Cognitive performance: Executive Function/working memory
Measured via Spatial Working Memory task, in CANTAB
Time frame: Change from baseline at 12-weeks
Change in concentration of microbial and host metabolites
Assessed via untargeted metabolomics analysis
Time frame: Change from baseline at 12-weeks
Change in levels of inflammatory markers
Assessed via inflammatory markers present in stimulated whole blood (including lipopolysaccharide) and unstimulated whole blood samples.
Time frame: Change from baseline at 12-weeks
Change in stress symptoms
Measured via the self-report Perceived Stress Scale (PSS). Scale range is from 0-40, higher number(s) indicate higher level of perceived stress.
Time frame: Change from baseline at 12-weeks
Plan to share: No
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University College Cork