Physical Activity-based Intervention in Depressed Patients: Clinical, Neurophysiological, Epigenetic and Metabolic Correlates
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 4
- 主要终点
- Zung Self-Rating Depression Scale
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Severe psychopathology
- •Medical contraindications to PA (PAR-Q)
- •Orthopedic problems/diseases which limit physical fitness assessment
- •Currently pregnant (or planning to become pregnant)
研究组 & 干预措施
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.
干预措施: Physical Activity (PA) program (Behavioral)
Control-arm
No intervention
结局指标
主要结局
Zung Self-Rating Depression Scale
时间窗: Baseline (Day 1); Month 3 (up to 3 months; end of treatment); Month 6 (up to 6 months, follow - up)
The Zung Self-Rating Depression Scale (ZDS) is a self-administered questionnaire designed to assess the level of depressive symptoms in individuals. It consists of 20 items, each rated on a scale from 1 to 4, based on how often symptoms are experienced. The raw total score ranges from 20 to 80, which is often converted to an index score (ranging from 25 to 100) by multiplying the raw score by 1.25. Higher scores indicate more severe depression
Montgomery-Åsberg Depression Rating Scale (MADRS)
时间窗: Baseline (day one), Month 3 (up to three months; end of treatment), Month 6 (up to 6 months; follow up).
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-administered scale designed to assess the severity of depressive symptoms. It consists of 10 items, each rated on a scale from 0 to 6, yielding a total score ranging from 0 to 60. Higher scores indicate greater severity of depression, meaning a worse clinical outcome.
Beck Depression Inventory - II
时间窗: Baseline (Day 1); Month 3 (up to 3 months; end of treatment); Month 6 (up to 6 months, follow - up)
The Beck Depression Inventory (BDI) is a self-report questionnaire used to assess the presence and severity of depressive symptoms. It comprises 21 items, each rated on a scale from 0 to 3, resulting in a total score ranging from 0 to 63. Higher scores reflect more severe depressive symptoms, indicating a worse clinical outcome.
Personal and Social Performance Scale
时间窗: Baseline (Day 1); Month 3 (up to 3 months; end of treatment); Month 6 (up to 6 months, follow - up)
The Personal and Social Performance Scale (PSP) is a clinician-rated instrument used to assess personal and social functioning in individuals with mental disorders. The total score ranges from 1 to 100, with higher scores indicating better functioning and a more favorable clinical outcome.
World Health Organization Quality of Life - Bref
时间窗: Baseline (Day 1); Month 3 (up to 3 months; end of treatment); Month 6 (up to 6 months, follow - up)
The WHOQOL-BREF is a self-report questionnaire developed by the WHO to assess quality of life across multiple domains. It contains 26 items rated on a 5-point Likert scale. Higher scores indicate a better quality of life, reflecting a more favorable outcome.
次要结局
- DNA Methylation(Baseline (Day 1); Month 3 (up to 3 months; end of treatment))
- Metabolic analyses(Baseline (Day 1); Month 3 (up to 3 months; end of treatment))
- Motor activity and circadian/sleep profiles(24h/day for 7 days before baseline, months 3 (at the end of the trial) and month 6 (up to 6 months follow up))
- EEG-derived neurophysiological metrics, including spectral, coherence, source localization, and graph-based connectivity measures(Baseline (Day 1); Month 3 (up to 3 months; end of treatment); Month 6 (up to 6 months, follow - up))
- Differentially Expressed genes and biological pathways modulation(Baseline (Day 1); Month 3 (up to 3 months; end of treatment))