Interest of Adaptated Physical Activity (APA) on the K Recovery Constant, Reflecting the Rate of Muscle Oxygenation Recovery in Menopausal Women Suffering From Depression
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- K recovery constant
研究概览
简要总结
APhyDeM is a randomized controlled study investigating the relationship between adapted physical activity and mitochondrial function in postmenopausal women with major depressive disorder.
Depression is associated with metabolic dysfunction, including alterations in mitochondrial activity and inflammatory processes. Physical activity has been shown to influence mitochondrial function, yet individuals with depression frequently experience reduced physical activity levels.
This study aims to evaluate whether an adapted physical activity program can improve mitochondrial function compared with a control intervention. Mitochondrial function will be indirectly assessed using near-infrared spectroscopy to measure post-exercise muscle oxygen recovery kinetics.
The study compares adapted physical activity with a non-physical therapeutic intervention in postmenopausal women receiving care in a psychiatric day hospital setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Menopaused women aged ≥ 40 years old,
- •Suffering from a major depressive episode according to international Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-V)
- •Presenting a score ≥11 on the 16-item Quick Inventory of Depressive Symptomatology Clinician Rating (QIDS-C16) depression scale
- •With a stabilized teatment by antidepressors since at least 4 weeks
排除标准
- •Medical contraindication for physical activity (cardio-vascular pathology, and/or previous cardiac disease)
- •Asthma or other unstabilized condition impairing the ability to perform physical exertion
- •Adipose tissue thickness measured on the forearm > 12 mm causing muscle oxygenation measurement by NIRS to be non contributive
研究组 & 干预措施
Adaptated Physical Activity (APA)
APA
干预措施: APA (Other)
Art therapy
Art therapy performed in routine healthcare
干预措施: CCATTP (Other)
结局指标
主要结局
K recovery constant
时间窗: Week 8
Relative difference of K recovery constant (min-1) reflecting the recovery speed of muscular oxygenation, assessed with muscular near-infrared spectroscopy (NIRS) at week 8, comparing with pre-randomization value. This measure is assessed at rest and following mitochondrial activation by MOTOmed15 movement therapy.
次要结局
- Recovery rate constant k (min-¹) reflecting post-exercise muscle oxygen reoxygenation kinetics.(Baseline, Week 8 (end of intervention), and Week 12 (4 weeks post-intervention).)
- Relative change in recovery rate constant k (min-¹) reflecting post-exercise muscle oxygen reoxygenation kinetics.(Week 8 (end of intervention) and Week 12 (4 weeks post-intervention))
- Depressive symptomatology(Baseline, Week 8, and Week 12)
- Fatigue(Baseline, Week 8, and Week 12)
- Suicidal ideation(Baseline, Week 8, and Week 12)
- Physical performance(Baseline, Week 8, and Week 12)
- Motivation for physical activity(Baseline, Week 8, and Week 12)
- Physical activity level(Baseline, Week 8, and Week 12)
- Physical and emotional pain(Baseline, Week 8, and Week 12)
- Motivation(Baseline, Week 8, and Week 12)
- Anhedonia(Baseline, Week 8, and Week 12)
- Psychomotor slowing(Baseline, Week 8, and Week 12)
- Health-related quality of life (SF-36 total score)(Baseline, Week 8, and Week 12)
- Inflammatory profile(Baseline, Week 8, and Week 12)