Interest of Adaptated Physical Activity (APA) on the K Recovery Constant, Reflecting the Rate of … (NCT07417709) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Interest of Adaptated Physical Activity (APA) on the K Recovery Constant, Reflecting the Rate of Muscle Oxygenation Recovery in Menopausal Women Suffering From Depression
France52 participantsStarted 2026-02
Plain-language 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. 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.
Who can participate
Age range
40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
K recovery constant
Timeframe: Week 8
Trial details
NCT IDNCT07417709
SponsorCentre Hospitalier Universitaire de Besancon