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

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Status: Active, not recruiting

Conditions: Major Depressive Disorder (MDD)

Treatments: Behavioral: Physical Activity (PA) program

Study type: Interventional

Funder types: Other

Identifiers

NCT06989944

PNRR-MCNT2-2023-12377777

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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110 participants in 2 patient groups

PA-arm

Experimental group

Description:

Participants assigned to the PA-arm will participate in at least three weekly 30-minute sessions of PA for a total of 12 weeks.

Treatment:

Behavioral: Physical Activity (PA) program

Control-arm

No Intervention group

Description:

No intervention