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NCT Number: NCT07417709

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

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.

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Key information

Conditions

Depression - Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Menopausal Depression Mental Disorders Mood Disorders

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Besançon

Besançon, France

Location contact

Karine CHARRIERE, PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

APA

Other

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

CCATTP

Other

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.

Primary outcomes

  1. K recovery constant

    Time frame: 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.

Secondary outcomes

  1. Recovery rate constant k (min-¹) reflecting post-exercise muscle oxygen reoxygenation kinetics.

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

    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.

  2. Relative change in recovery rate constant k (min-¹) reflecting post-exercise muscle oxygen reoxygenation kinetics.

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

    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.

  3. Depressive symptomatology

    Time frame: Baseline, Week 8, and Week 12

    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.

  4. Fatigue

    Time frame: Baseline, Week 8, and Week 12

    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.

  5. Suicidal ideation

    Time frame: Baseline, Week 8, and Week 12

    Suicidal ideation will be assessed using the Beck Scale for Suicide Ideation (SSI) and the Columbia-Suicide Severity Rating Scale (C-SSRS). Measurements will be compared to baseline in both study arms.

  6. Physical performance

    Time frame: Baseline, Week 8, and Week 12

    Physical performance will be assessed using the following tests: bilateral handgrip strength with a dynamometer, the 30-second chair stand test, and the 6-minute walk test. Measurements will be compared to baseline in both study arms.

  7. Motivation for physical activity

    Time frame: Baseline, Week 8, and Week 12

    Motivation will be assessed using the Behavioral Regulation in Exercise Questionnaire - 2, short version (BREQ-2). Measurements will be compared to baseline in both study arms.

  8. Physical activity level

    Time frame: Baseline, Week 8, and Week 12

    Physical activity will be assessed using a self-reported weekly activity questionnaire and a participant activity logbook. Measurements will be compared to baseline in both study arms.

  9. Physical and emotional pain

    Time frame: Baseline, Week 8, and Week 12

    Pain will be assessed using the Visual Analog Scale for Physical and Emotional Pain (PPP-VAS2). Measurements will be compared to baseline in both study arms.

  10. Motivation

    Time frame: Baseline, Week 8, and Week 12

    Motivation will be assessed using the Effort Expenditure for Rewards Task (EEfRT) computerized test coupled with a cycle ergometer. Measurements will be compared to baseline in both study arms.

  11. Anhedonia

    Time frame: Baseline, Week 8, and Week 12

    Anhedonia will be assessed using the Snaith-Hamilton Pleasure Scale (SHAPS). Measurements will be compared to baseline in both study arms.

  12. Psychomotor slowing

    Time frame: Baseline, Week 8, and Week 12

    Psychomotor slowing will be assessed using the Échelle de Ralentissement Dépressif (ERD). Measurements will be compared to baseline in both study arms.

  13. Health-related quality of life (SF-36 total score)

    Time frame: Baseline, Week 8, and Week 12

    Quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). Measurements will be compared to baseline in both study arms.

  14. Inflammatory profile

    Time frame: Baseline, Week 8, and Week 12

    Inflammatory status will be assessed using C-reactive protein (CRP) measurements performed as part of routine clinical care. Measurements will be compared to baseline in both study arms.

Study contacts

Contact information is provided by the study sponsor or research team.

Karine CHARRIERE, PhD

CONTACT

[email protected]

+33 3 81 21 89 99

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Acronym: APhyDeM

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 18, 2026
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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