RecruitingNot ApplicableNCT06989944

Physical Activity-based Intervention in Depressed Patients: Clinical, Neurophysiological, Epigenetic and Metabolic Correlates


Sponsor

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Enrollment

110 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to investigate the effect of a structured physical activity (PA) program on depressive symptomatology in adults with a diagnosis of major depression disorder (MDD). The study will evaluate changes in depressive symptoms and assess neurophysiological and biological modulations, including epigenetic, transcriptomic, and metabolic changes resulting from the PA intervention. The main questions it aims to answer are: * Does physical activity have an impact on depressive symptoms in patients affected by depression? * What are the neurophysiological, epigenetic, and metabolic mechanisms through which PA can modulate the intensity of depressive symptoms? Participants will be randomized into two arms: the intervention group (n total=55), in treatment with antidepressants, participating in a 12-weeks PA program; the control group (n total=55), patients in treatment with antidepressants, without receiving the PA program. All participants will be assessed at three-time points: T0 (baseline, before initiating the trial), T3 (after three months; at the end of the 12-week PA program), and T6 (6th-month follow up; three months after the PA completion). At each assessment, all participants will: * Complete clinical evaluation questionnaires * Provide blood samples * Undergo electroencephalogram (EEG) measurements. * Wear an actigraph 24 hours a day for 7 days before the initiation of the trial, at T3, and at T6.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • Age \> 18 years
  • Primary diagnosis of depression (DSM-5 criteria)
  • Symptoms of depression according to MADR, BDI, ZDR Scale
  • Ability to provide written IC
  • Self-reported moderate-intensity leisure PA\< 150 min/week

Exclusion Criteria4

  • Severe psychopathology
  • Medical contraindications to PA (PAR-Q)
  • Orthopedic problems/diseases which limit physical fitness assessment
  • Currently pregnant (or planning to become pregnant)

Interventions

BEHAVIORALPhysical Activity (PA) program

Participants assigned to the PA-arm will participate in at least three weekly 30-minute sessions of PA for a total of 12 weeks. The PA program will be tailored to individuals' characteristics, skills and preferences, based on information collected in connection with the baseline assessment and physical examination. A PA program could preview some forms of aerobic/relaxation/anaerobic exercises


Locations(4)

IRCCS Centro San Giovanni fi Dio Fatebenefratelli

Brescia, Italy

Istituto Neurologico Mediterraneo Neuromed, NEUROMED

Isernia, Italy

IRCCS Ospedale San Raffaele

Milan, Italy

Azienda Sanitaria Locale di Pescara

Pescara, Italy

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NCT06989944


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