About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
APA
Other intervention3 sessions/week of APA (1h yoga, 1h dance, 1h muscle strengthening)
CCATTP
Other intervention2 sessions/week of 2 hours art therapy. This approach is already used in routine healthcare and is not a procedure specific to the study.
Treatment groups
Trial outcomes
Primary outcomes
K recovery constant
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.
Secondary outcomes
Recovery rate constant k (min-¹) reflecting post-exercise muscle oxygen reoxygenation kinetics.
The recovery rate constant k will be assessed using near-infrared spectroscopy (NIRS). Measurements will be performed at rest and following mitochondrial activation induced by standardized exercise using a MOTOMed device.
Relative change in recovery rate constant k (min-¹) reflecting post-exercise muscle oxygen reoxygenation kinetics.
The relative change in k will be calculated from baseline (pre-randomization) to post-intervention time points using near-infrared spectroscopy (NIRS). Measurements will be performed at rest and following mitochondrial activation with the MOTOMed device.
Depressive symptomatology
Depression will be assessed using the Quick Inventory of Depressive Symptomatology - Clinician Rated, 16-item version (QIDS-C16) and Self-Report, 16-item version (QIDS-SR16). Measurements will be compared to baseline in both study arms.
Fatigue
Fatigue will be assessed using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue). Measurements will be compared to baseline in both study arms.
Sponsors and contacts
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