Depression - Major Depressive DisorderAPhyDeMNCT07417709
Interest of Adaptated Physical Activity (APA) on the K Recovery Constant, Reflecting the Rate of Muscle Oxygenation Recovery in Menopausal Women Suffering From Depression
A study testing APA and CCATTP in people with Depression - Major Depressive Disorder and Menopausal Depression, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Depression - Major Depressive Disorder, Menopausal Depression
- What is being tested?
- APA and CCATTP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2026to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU de Besançon
Besançon
Karine CHARRIERE, PhD, kcharriere@chu-besancon.fr
About this study
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.
Read more
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.
- Being tested
- APA, CCATTP
- Keywords
- postmenopausal women, major depressive disorder, adapted physical activity
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APAOther
3 sessions/week of APA (1h yoga, 1h dance, 1h muscle strengthening)
CCATTPOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Adaptated Physical Activity (APA) | Experimental | APA Receives: Other: APA |
| Art therapy | Active comparator | Art therapy performed in routine healthcare Receives: Other: CCATTP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 8
Secondary outcomes (14)
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.
Measured: 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.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 8, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Djamila BENNABI, MD PhD, Principal investigator, CHU de Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417709
- Sponsor's protocol ID
- 2024/917
- Acronym
- APhyDeM
- Status last verified
- Nov 2025
- First submitted
- 11 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Adaptated Physical Activity (APA) on the K Recovery Constant, Reflecting the Rate of Muscle Oxygenation Recovery in Menopausal Women Suffering From Depression
- ClinicalTrials.gov ID
- NCT07417709
- Acronym / sponsor ID
- APhyDeM / 2024/917
- Keywords
- postmenopausal women, major depressive disorder, adapted physical activity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adaptated Physical Activity (APA) | Experimental | Other: APAAPA |
| Art therapy | Active comparator | Other: CCATTPArt therapy performed in routine healthcare |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APA3 sessions/week of APA (1h yoga, 1h dance, 1h muscle strengthening) | Other | Adaptated Physical Activity (APA) |
| CCATTP2 sessions/week of 2 hours art therapy. This approach is already used in routine healthcare and is not a procedure specific to the study. | Other | Art therapy |
Primary outcome
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.
14 secondary outcomes
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).
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)
Depressive symptomatology
Time frame: Baseline, Week 8, and Week 12
Fatigue
Time frame: Baseline, Week 8, and Week 12
Suicidal ideation
Time frame: Baseline, Week 8, and Week 12
Physical performance
Time frame: Baseline, Week 8, and Week 12
Motivation for physical activity
Time frame: Baseline, Week 8, and Week 12
Physical activity level
Time frame: Baseline, Week 8, and Week 12
Physical and emotional pain
Time frame: Baseline, Week 8, and Week 12
Motivation
Time frame: Baseline, Week 8, and Week 12
Anhedonia
Time frame: Baseline, Week 8, and Week 12
Psychomotor slowing
Time frame: Baseline, Week 8, and Week 12
Health-related quality of life (SF-36 total score)
Time frame: Baseline, Week 8, and Week 12
Inflammatory profile
Time frame: Baseline, Week 8, and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Djamila BENNABI, MD PhD principal investigator
CHU de Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APA and CCATTP in people with Depression - Major Depressive Disorder and Menopausal Depression, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karine CHARRIERE, PhD (+33 3 81 21 89 99, kcharriere@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
K recovery constant (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.