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)

February 11, 2026 updated by: Centre Hospitalier Universitaire de Besançon

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adaptated Physical Activity (APA)
APA
Other: APA
3 sessions/week of APA (1h yoga, 1h dance, 1h muscle strengthening)
Active Comparator: Art therapy
Art therapy performed in routine healthcare
Other: CCATTP
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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
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.
Baseline, Week 8, and Week 12
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.
Baseline, Week 8, and Week 12
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.
Baseline, Week 8, and Week 12
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.
Baseline, Week 8, and Week 12
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.
Baseline, Week 8, and Week 12
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.
Baseline, Week 8, and Week 12
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.
Baseline, Week 8, and Week 12
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.
Baseline, Week 8, and Week 12
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.
Baseline, Week 8, and Week 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.
Baseline, Week 8, and Week 12
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.
Baseline, Week 8, and Week 12
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.
Baseline, Week 8, and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besançon

Investigators

  • Principal Investigator: Djamila BENNABI, MD PhD, CHU de Besançon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

November 1, 2028

Study Registration Dates

First Submitted

February 11, 2026

First Submitted That Met QC Criteria

February 11, 2026

First Posted (Actual)

February 18, 2026

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/917

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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