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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2026-02-01

Brief Summary

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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 and neurophysiological profiles in patients affected by depression?
* What are the 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).

Throughout the 12-week PA program, participants will keep a diary of their physical activity (minutes per day) and sleep patterns (hours per night).

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Detailed Description

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Conditions

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Major Depressive Disorder (MDD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two-arm randomized controlled design

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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PA-arm

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

Group Type EXPERIMENTAL

Physical Activity (PA) program

Intervention Type BEHAVIORAL

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

Control-arm

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Physical 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No