Tests aerobic exercise for people with depression
Tests a 12-week aerobic exercise program in adults with major depressive disorder.
Key facts
- Who runs it
- University College Cork
- Where
- Cork, IrelandSee the site
- Trial code
- Registry title
- The Effects of Exercise on Gut Bacteria, Mood and Cognition in Depression
- Status
- Recruiting
- People taking part
- 40 people, planned
- Started
- 14 Feb 2024
- Planned end
- Jul 2026
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Aerobic Exercise
- Record updated
- 8 November 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 59 with current major depression who do not already get enough aerobic exercise. They will be asked to do 12 weeks of cardio exercise or to continue usual care.
- Age
- 18 to 59 years
- Sex
- All sexes
- Disease stage
- Current diagnosis of major depressive disorder with a current depression episode, shown by a Beck's depression inventory-II score of 13-31. Living in the community.
- Earlier treatment
- A change of medicine less than 2 weeks before the start cannot be accepted. Certain medicines such as antibiotics, probiotics, corticosteroids and anti-inflammatory drugs need a 4-week break before joining. No experimental drug treatment in the last 30 days.
Main reasons for not taking part
- Serious ongoing illness, such as heart, bowel, immune, metabolic or lung disease, bipolar disorder, schizophrenia or psychosis
- Already meeting national physical activity guidelines through structured aerobic exercise
- Pregnant, planning pregnancy, breastfeeding, or in perimenopause, menopause or post-menopause
- Smoking daily, regular illegal drug use, alcohol abuse disorder, or current eating disorder
- Suicidal crisis or suicide attempt in the past 6 months
The registry criteria, word for word
Show all 21 criteriaShow less
Who can take part
- 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)
Who cannot take part
- Change of pharmacological therapy less than 2 weeks prior to beginning of study (including beginning pharmacological treatment)
- Have a malignant disease or any concomitant end-stage organ disease
- 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
- Regular, illegal drug use
- 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])
- 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
- Alcohol abuse disorder
- Current eating disorder (anorexia nervosa, bulimia nervosa, binge eating disorder)
- 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
- Are meeting the national physical activity guidelines (16) (i.e., at least 30 minutes a day of moderate intensity activity, five days a week (or 150 minutes a week), specifically in relation to structured aerobic exercise, as assessed via the international physical activity questionnaire (IPAQ). NB: if guidelines are met from occupational or incidental physical activity, individuals would not meet exclusion criteria
- 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
- Acute suicidality or suicide attempt in the past 6 months
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 59 years old?
Where in Ireland
- University College Cork, APC Microbiome IrelandCork, IrelandContact: Move4Mood Study RecruitmentTaking people
About the trial
What the trial wants to find out
This study aims to investigate the effects of a 12-week aerobic (cardio) exercise intervention in people with Major Depressive Disorder.
Read full original descriptionShow less
Measurements taken before, during, and following the 12-week intervention will include assessments of cognition, cardiorespiratory fitness, stress, mood and emotion, and gut bacteria.
The 2 groups in the trial
- Usual CareNo study treatment, for comparison
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 CareTreatment being tested
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.
Treatment: Aerobic Exercise
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Investigating the Effects of an Exercise Intervention on Gut Bacteria, Mood and Cognition in Individuals With Major Depressive Disorder
- Plain-language title
- Tests aerobic exercise for people with depressionGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06398496, who can take part
- Record updated
- 8 November 2024