Menu
Not yet recruiting 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

No phase Interventional Depression - Major Depressive Disorder Menopausal Depression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: APA, CCATTP.
Who it may be relevant to
Registry conditions: Depression - Major Depressive Disorder, Menopausal Depression. Basic parameters: from 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • K recovery constant [Time frame: Week 8]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • CHU de Besançon — Besançon

Identifiers

NCT: NCT07417709 · 2024/917

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗