CClinicalTrials.gg
Status unknownNCT05019183DEPRIVUpdated Aug 31, 2021

Clinical Impact and Neuro-functional Substrate of Immersive Virtual Reality Sports Practice on Depression

An interventional study of Physical training and Virtual reality in Depression, sponsored by Direction Centrale du Service de Santé des Armées. Status unknown at 3 sites in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-08-31.

Sponsored by Direction Centrale du Service de Santé des Armées · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Aug 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Depression is a major public health issue due to its frequency (prevalence of 7.5% in adults), its difficulties in therapeutic management (ineffective in 30% of cases and poor compliance) and its societal cost (170 billion euros per year). The most frequent clinical expression is a characterized depressive episode.

Physical activity, through better management of emotions and stress, has been proposed as a complementary therapeutic approach in depression. Studies have shown a decrease in depressive symptoms during a sports program of at least 2 weeks in addition to pharmacological treatment. Similarly, mindfulness meditation, because it reduces ruminations, could also improve the therapeutic management of depression. More recently, virtual reality (VR) exposure therapy has also been proposed in the treatment of anxiety and depression, with a benefit of multisensory stimulation induced by a virtual environment in cognitive and sensory-motor rehabilitation and emotion regulation. However, these therapeutic strategies, in addition to pharmacological treatments, have limits. There is thus a real challenge in designing innovative therapeutic programs for the treatment of depression that encourage motivated practice. A sports activity coupled with immersion in VR could combine the benefits of each of these treatments. With the emergence of new immersive technologies, VR allows the recreation of sensory experiences in an environment close to the ecological context. The use of physical activity on an indoor rower or other sensor-equipped device could thus intensify the psychological benefits of exercise and improve compliance. However, there is a lack of clinical evidence to recommend this coupled therapeutic approach in the additional treatment of depression. This approach is part of the embodied virtual medicine road map.

Furthermore, a better understanding of the biological, metabolomic, and cerebral mechanisms underlying this approach could improve its effectiveness. It would make it possible to propose and evaluate biomarkers for therapeutic and prognostic monitoring of depression. In particular, progress in the field of the "-omics" family includes new tools with great potential. This is more specifically the case of metabolomics. The analysis of metabolites present in the organism or released with natural secretions would allow to constitute a metabolomic signature evolving during the treatment. The interest in characterizing metabolomic biomarkers is an interesting avenue to meet the need to establish a biological diagnosis with quantified values, for better objectivity and follow-up. Functional imaging could also be used to highlight regional activity or connectivity anomalies and markers of response to therapy in relation to biology.

The aim of this work is to determine the clinical impact of physical exercise in VR on a depressive state, and to study in biology, metabolomics and neuroimaging the functional substrates of such a practice in order to understand the mechanisms involved and to propose ways to improve the management of depression.

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Conditions studied

03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,643 are open to participants now.

This study's planned enrollment of 50 is below the median of 84 across 6,718 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Direction Centrale du Service de Santé des Armées is the lead sponsor of 93 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients between the ages of 18 and 65
  • with a diagnosis of characterized depressive episode according to the DSM-5 criteria
  • able to practice indoor rower.

Exclusion criteria

Exclusion Criteria:

  • Pregnant or breastfeeding women
  • With major depression as part of bipolar affective disorder
  • Presence of a suicidal risk
  • Under Cognitive behavioral therapy or whose medication has been modified in the month preceding enrollment
  • History of neurological pathology, head injury or mental retardation
  • Presence of an addictive comorbidity
  • Presence of a major organic pathology
  • Presence of a contraindication to virtual reality exposure
  • Presence of a contraindication to SPECT
  • Presence of a predisposition to discomfort caused by mobile environments
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Experimental arm

    Patients in the experimental arm will perform 6 indoor rower sessions (30 min each, on Day 1, 2, 3, 8, 9 and 10) during which they will be able to move freely in a virtual environment.

    Other: Physical training · Other: Virtual reality · Device: Single-photon emission computed tomography (SPECT) · Biological: Metabolomics

  • Other
    Control arm

    Patients in the control arm will perform 6 indoor rower sessions (30 min each, on Day 1, 2, 3, 8, 9 and 10) without being exposed to a virtual environment.

    Other: Physical training · Device: Single-photon emission computed tomography (SPECT) · Biological: Metabolomics

Interventions

  • OtherPhysical training

    The subjects will perform 6 indoor rower sessions (30 min each, on Day 1, 2, 3, 8, 9 and 10) with a target heart rate zone of 60%.

  • OtherVirtual reality

    The subjects will be able to move freely in virtual environments while training on the indoor rower.

  • DeviceSingle-photon emission computed tomography (SPECT)

    SPECT allows the measurement of cerebral perfusion, reflecting the global synaptic activity, via a 3D acquisition of 20 minutes, 15 minutes after injection of 740 MBq of radiotracers (ECD - Neurolite or HMPAo - Cerestab), with iterative reconstruction. The data will be processed at the voxel scale by the SPM12 software, with analysis of brain connectivity.

  • BiologicalMetabolomics

    This qualitative approach will aim to identify pathways that are not known (or have not been explored) to optimize the chances of detecting metabolites present depending on the group (physical activity coupled or not with VR). This method is favorable for biomarker discovery.

06

What researchers measure

Primary outcomes

  1. Change in the Questionnaire Inventory of Depressive Symptomatology (QIDS-SR) depression scale score between Day 1 and Day 10

    This questionnaire is built on the 9 symptoms used in the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5): sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance, decreased/increased appetite or weight, and psychomotor slowing/agitation. The total score ranges from 0 to 27 with higher scores meaning higher levels of depression.

    Time frame: From Day 1 to Day 10

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Study locations

3 sites
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05019183
Lead sponsor
Direction Centrale du Service de Santé des Armées
Responsible party
Sponsor
First posted
Aug 24, 2021
Start date
Sep 2021 (estimated)
Primary completion
Sep 2022 (estimated)
Completion
Sep 2022 (estimated)
Last update
Aug 31, 2021

Study contacts

Marion TROUSSELARD, MD, PhD
Contact
marion.trousselard@intradef.gouv.fr
178651255 ext. +33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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