Interest of Adaptated Physical Activity (APA) on the K Recovery Constant, Reflecting the Rate of Muscle Oxygenation Recovery in Menopausal Women Suffering From Depression

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40+
SponsorCentre Hospitalier Universitaire de Besancon

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • APA

    Other intervention

    3 sessions/week of APA (1h yoga, 1h dance, 1h muscle strengthening)

  • CCATTP

    Other intervention

    2 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

52 Participants
are divided into 2 treatment groups
Group A: Adaptated Physical Activity (APA)Experimental treatment 1 intervention
Group B: Art therapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Week 8

Secondary outcomes

1

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.

Time frame
Baseline, Week 8 (end of intervention), and Week 12 (4 weeks post-intervention).
2

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.

Time frame
Week 8 (end of intervention) and Week 12 (4 weeks post-intervention)
3

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.

Time frame
Baseline, Week 8, and Week 12
4

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.

Time frame
Baseline, Week 8, and Week 12

Other outcomes

Sponsors and contacts

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