The Effects of Exercise on Gut Bacteria, Mood and Cognition in Depression

NCT06398496 | Recruiting

• 1 other identifier: APC185
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depressive Disorder, Major

Keywords

gut bacteria; exercise; cardiorespiratory fitness; negative biases

Outcome Measures

Primary Outcomes (5)

• Depression symptom change

  Depression symptoms measured via self-report questionnaire (Beck's Depression Inventory-II).

  Change from baseline at 12-weeks

• Negative and positive affect change

  Negative and positive affect, measured via self-report positive affect negative affect schedule.

  Change from baseline at 12-weeks

• Gut microbiota change

  Gut microbiota, measured via sequencing of stool samples (including measures of diversity, composition, and function).

  Change from baseline at 12-weeks

• Cognitive performance: affective perceptual bias

  Emotional bias, measured via Emotional bias task via CANTAB.

  Change from baseline at 12-weeks

• Cognitive performance: social cognition

  Emotional recognition, measured via Emotional recognition task via CANTAB.

  Change from baseline at 12-weeks

Secondary Outcomes (8)

• Cardiorespiratory fitness change

  Change from baseline at 12-weeks

• Cognitive performance: Psychomotor function

  Change from baseline at 12-weeks

• Cognitive performance: Attention

  Change from baseline at 12-weeks

• Cognitive performance: Executive Function

  Change from baseline at 12-weeks

• Cognitive performance: Executive Function/working memory

  Change from baseline at 12-weeks

Study Arms (2)

Usual Care

NO INTERVENTION

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.

Aerobic Exercise + Usual Care

EXPERIMENTAL

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

Interventions

Aerobic Exercise BEHAVIORAL

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

Aerobic Exercise + Usual Care

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Be able to give written informed consent.
• Be between 18 and 59 years of age.
• Be in generally good health as determined by the investigator (excluding Major Depressive Disorder diagnosis).
• Community dwelling with a current diagnosis of Major Depressive Disorder, and current depression episode/symptoms as determined via Beck's depression inventory-II (score 13-31).

You may not qualify if:

• Change of pharmacological therapy less than 2 weeks prior to beginning of study (including beginning pharmacological treatment).
• Have a significant acute or chronic coexisting illness \[cardiovascular, gastrointestinal (GI) \[including functional GI disorders, inflammatory bowel disease, coeliac disease\], immunological, psychiatric \[to include formal/clinical diagnosis or as determined via participant self-report i.e., bipolar spectrum disorder, schizophrenia, or psychosis, but not anxiety disorder\], neurodevelopmental or neurodegenerative disorders, metabolic disorders \[to include type I or II diabetes\], or any condition which contraindicates, in the investigators judgement, entry to the study (including conditions which may prevent an individual from safely participating in low-to-moderate exercise intensities (57-76% heart rate max \[HRmax\], rating of perceived exertion \[RPE\]:9-13 (13))-i.e., cardiorespiratory disease\[s\]).
• Have a malignant disease or any concomitant end-stage organ disease.
• Having a condition or taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk, or confound the interpretation of the study results; to include anti- inflammatory drugs, corticosteroids, laxatives, enemas, proton-pump inhibitors, antibiotics, or probiotics (within 1 month of starting study), anti-coagulants, thrombocyte-aggregation blocking medication(s) and over-the counter non-steroidal analgesics. Participants should have a wash-out period of four-weeks of the above-mentioned medication to be eligible for participation.
• Individuals who are considered to be poor attendees, in the opinion of the investigator, or unlikely for any reason to be able to comply with the trial.
• Participants must not be currently receiving treatment involving experimental drugs. If the participant has been in a recent experimental trial, these must have been completed not less than 30 days prior to this study.
• Current perimenopause, menopause, or post-menopause, in the case of females.
• Females who are pregnant, planning a pregnancy within duration of the study intervention period, or currently lactating.
• Participants who are not fluent in English or English is not first language.
• Are colour blind.
• Have dyslexia or dyscalculia.
• Are a current habitual daily smoker.
• Regular, illegal drug use.
• Alcohol abuse disorder.
• Acute suicidality or suicide attempt in the past 6 months.

Sponsors & Collaborators

• University College Cork: lead

Study Sites (1)

University College Cork, APC Microbiome Ireland

Cork, Cork County, Ireland

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Gerard Clarke, PhD

  University College Cork, APC Microbiome Ireland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Move4Mood Study Recruitment

CONTACT

(+353) 021 4901721; move4mood@ucc.ie

Nathan D Nuzum, PhD

CONTACT

nnuzum@ucc.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants randomized to either a control (usual care only) or exercise (usual care + aerobic exercise) intervention group. 'Usual care' is whatever the participant's current treatment plan is, including pharmacological and psychological treatment.

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 3, 2024
• Study Start: February 14, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)