Tests aerobic exercise for people with depression
Tests a 12-week aerobic exercise program in adults with major depressive disorder.
Plain-language title generated from the registry record
Registry title: The Effects of Exercise on Gut Bacteria, Mood and Cognition in Depression
Key facts
- Where
- Cork, IrelandSee the site
Could this be for you?
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?
Source: NCT06398496, who can take part
Where in Ireland
- University College Cork, APC Microbiome IrelandCork, IrelandTaking people
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?
Trial details
- Who runs it
- University College Cork
- Trial code
- NCT06398496
- Record updated
- 8 November 2024
- Original description
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
Investigating the Effects of an Exercise Intervention on Gut Bacteria, Mood and Cognition in Individuals With Major Depressive Disorder
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.
Inclusion: 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).
Exclusion: 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.