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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adaptated Physical Activity (APA) | Experimental | APA |
|
| Art therapy | Active Comparator | Art therapy performed in routine healthcare |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APA | Other | 3 sessions/week of APA (1h yoga, 1h dance, 1h muscle strengthening) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 8 (end of intervention), and Week 12 (4 weeks post-intervention). |
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Inclusion Criteria:
Exclusion Criteria:
Only individuals who self-identify as female are eligible to participate.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karine CHARRIERE, PhD | Contact | +33 3 81 21 89 99 | kcharriere@chu-besancon.fr |
| Name | Affiliation | Role |
|---|---|---|
| Djamila BENNABI, MD PhD | CHU de Besançon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Besançon | Besançon | France |
|
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| 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. |
|
| 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. | Week 8 (end of intervention) and Week 12 (4 weeks post-intervention) |
| 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. | Baseline, Week 8, and Week 12 |
| 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. | Baseline, Week 8, and Week 12 |
| Suicidal ideation | 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. | Baseline, Week 8, and Week 12 |
| Physical performance | 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. | Baseline, Week 8, and Week 12 |
| Motivation for physical activity | 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. | Baseline, Week 8, and Week 12 |
| Physical activity level | 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. | Baseline, Week 8, and Week 12 |
| Physical and emotional pain | 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. | Baseline, Week 8, and Week 12 |
| Motivation | 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. | Baseline, Week 8, and Week 12 |
| Anhedonia | Anhedonia will be assessed using the Snaith-Hamilton Pleasure Scale (SHAPS). Measurements will be compared to baseline in both study arms. | Baseline, Week 8, and Week 12 |
| Psychomotor slowing | Psychomotor slowing will be assessed using the Échelle de Ralentissement Dépressif (ERD). Measurements will be compared to baseline in both study arms. | Baseline, Week 8, and Week 12 |
| Health-related quality of life (SF-36 total score) | 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. | Baseline, Week 8, and Week 12 |
| Inflammatory profile | 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. | Baseline, Week 8, and Week 12 |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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