Cerebral and Anti-inflammatory Response Through Exercise - Mechanisms In Depressive Disorders
Inflammatory and Brain Mechanisms and Clinical and Cognitive Effects of an Exercise Intervention in Major Depressive Disorder: a Randomised Longitudinal Clinical Trial.
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
124 participants
Apr 21, 2025
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to study how physical exercise works when applied to patients diagnosed with Major Depressive Disorder (MDD). The main questions it aims to answer are: * What are the antiinflammatory and oxidative stress and neural mechanisms involved in the antidepressant effects of exercise? * How effective is a physical exercise program in MDD patients in real-life conditions? The experimental group will receive an exercise intervention as an add-on to their usual treatment (antidepressant treatment prescribed by the attending specialist). Researchers will compare to a control group, which will only receive standard treatment (antidepressant treatment prescribed by the attending specialist) and will be instructed to not change their usual physical activity. The aim is to see if a physical exercise intervention would induce a significant improvement in depressive symptoms and which mechanisms are responsible for this result.
Eligibility
Inclusion Criteria4
- A diagnosis of Major Depressive Disorder (MDD) according to DSM-5 criteria (through the Mini International Neuropsychiatric Interview (MINI)
- Severity of depression according to the Hamilton Depression Rating Scale 17 items (HAM-D17): minimum of 14 cut-off score of moderate depression.
- Outpatient clinical care.
- Current antidepressant treatment that will be maintained during the 12 weeks of the physical exercise intervention.
Exclusion Criteria7
- Diagnosis of any axis I diagnosis except for MDD;
- Contraindications for Magnetic Resonance Imaging.
- Antiinflammatory treatments or antibiotics within the week before randomisation.
- Vaccines within the month before randomisation.
- Fever (\>38ºC) at the moment of study entry.
- Pregnant women.
- Alcohol or drug abuse.
Interventions
Daily walking. Participants will be given an activity band to self-monitor the number of steps they walk each day during the 12-week intervention period. Each participant must reach a certain number of daily steps with a progressive goal adjusted to the number of steps from the previous week. The goal is set considering the superior number to the median of steps of the preceding week. Weekly combined exercise sessions (aerobic + strength exercise) 2 sessions of 60 minutes per week in a 12-week program. The exercise intervention will combine the use of elastic bands and the body weight. First, 5 minutes of warm-up; second, training circuit with low-intensity strength exercises alternating work and rest times using rhythmic music. Upper, lower and middle body exercises will alternate. The program will progress in intensity, work: rest ratio, and technical difficulty of the exercises. At the end of the main part, there will be a cool-down and stretching for 5 minutes.
Patients will receive their standard antidepressant treatment prescribed by their psychiatrist.
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06450704