Cerebral and Anti-inflammatory Response Through Exercise - Mechanisms In Depressive Disorders

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.

Conditions

• Major Depressive Disorder
• Inflammatory Response

Interventions

DRUG

Antidepressant medication (ADM)

Patients will receive their standard antidepressant treatment prescribed by their psychiatrist.

OTHER

Physical Exercise

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.

Sponsors & Collaborators

• Hospital Universitario La Paz

  collaborator OTHER

• Hospital Universitario Ramon y Cajal

  collaborator OTHER

• Hospital Universitario Principe de Asturias

  collaborator OTHER

• Quirón Madrid University Hospital

  collaborator OTHER

• Universidad Autonoma de Madrid

  collaborator OTHER

• Centro de Investigación Biomédica en Red de Salud Mental

  collaborator NETWORK

• Hospital Universitario Puerta de Hierro de Majadahonda

  collaborator UNKNOWN

• Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

  lead OTHER

Principal Investigators

• Pilar López García, PhD · Universidad Autonoma de Madrid

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-21

Primary Completion

2026-09-01

Completion

2026-12-31

Countries

• Spain

Study Locations