NCT06817980

Brief Summary

Schizophrenia (SZ) patients with metabolic syndrome, patients with vestibular syndrome, and patients with borderline personality disorder, would benefit from physical activity (PA). Yet patient adherence to PA is low, at least in the case of SZ. the investigators work and the literature lead the investigators to consider that, in addition to motivational aspects, disorders of the bodily sense of self could play a role in this lack of adherence. Simply walking involves visual movements related to the self, which must be distinguished from movements in the environment. This means a distinction between self and not-self. Furthermore, these movements are all the more difficult to distinguish as they may also result from the fact that hidden objects become visible as a result of our own movement. In all sense-of-self disorders can themselves affect physical training, and the investigators will measure them in the first stage. In the second stage, the investigators will apply a standard, risk-free PA protocol by walking (3x3 sessions of 30 min). the investigators will test the impact of physical training on the sense of self under different conditions, with one environment minimizing self-related movement, vs. 2 environments with a variable level of enrichment (i.e. hidden objects inducing more or less self-related movement). At the end of the protocol, the investigators will offer participants who wish to take part in an ancillary study, i.e. a walking session with mixed-reality goggles. These will superimpose a luminous flux on the periphery of the visual field. According to results obtained in the laboratory, this flux could restore sensory mechanisms impaired in schizophrenia. the investigators will use these glasses in the most difficult condition for the patient, and verify their impact.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
29mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress23%
Sep 2025Sep 2028

First Submitted

Initial submission to the registry

December 16, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 10, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

August 6, 2025

Status Verified

December 1, 2024

Enrollment Period

3 years

First QC Date

December 16, 2024

Last Update Submit

August 1, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Impact of physical activity on the 'self' measure

    Quantification of the d' index, which represents the ability to discriminate between moving and static lines (whose movement is only related to one's own displacement, which induces a mirror movement on the retina). The d' will be measured three times per PA session, and in all 3 sessions per condition (neutral vs. enriched, with increasing complexity of self-related movements). The evaluation criterion will be the evolution of the d' index over the course of the PA training sessions in the 3 conditions.

    Day 0

  • Impact of physical activity on the 'self' measure

    Quantification of the d' index, which represents the ability to discriminate between moving and static lines (whose movement is only related to one's own displacement, which induces a mirror movement on the retina). The d' will be measured three times per PA session, and in all 3 sessions per condition (neutral vs. enriched, with increasing complexity of self-related movements). The evaluation criterion will be the evolution of the d' index over the course of the PA training sessions in the 3 conditions.

    between Day 0 and Month 3

Study Arms (1)

Self and physical activity protocol

EXPERIMENTAL
Behavioral: Physical activity

Interventions

\- Physical activity: We will compare the impact of 3 different environments (with no object in the environment, vs. with some objects but no hidden objects vs. with objects at the fore- and background) during (total of 9 sessions of 30 minutes + 3\*5 minutes of testing), on the measure of self (see below). Visit 10: We will repeat a walking session. Participants will wear mixed-reality goggles, which allow them to visualize the environment and superimpose a continuous stream of light. This session is intended to test the idea that this flow would enable SZ patients to suffer less from the discontinuous appearance of information when moving around. Measure of 'self' : the participants will decide whether the line presented on a computer screen is static or moving. They will be immobile, walking on the spot in front of the computer, or passively mobilized with a whole-body movement platform. The latter condition will be used only in the first phase of the protocol

Self and physical activity protocol

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Criteria common to all participants:
  • Men or women aged 18 to 60 inclusive
  • Subject affiliated to a health insurance scheme, beneficiary or beneficiary's beneficiary
  • Able to understand the aims and risks of the research, and to give informed consent
  • Visual acuity \> 0.7 on the Freiburg Vision Test (Bach 1996) due to the use of visual equipment
  • BMI (body mass index) \< 40 (due to cardiovascular risk).
  • Patient-specific criteria:
  • With schizophrenia: criteria for schizophrenia as defined in the DSMV (American Psychiatric Association, 2015)
  • With borderline personality disorder: criteria for borderline personality disorder as defined in the DSMV (American Psychiatric Association, 2015)
  • With vestibular disorders: peripheral vestibular disorders established after otolaryngological examination

You may not qualify if:

  • Criteria common to all participants:
  • Serious or unstabilized somatic pathology (including cardiovascular)
  • History likely to affect cerebral anatomy or to be linked to an abnormality (neonatal suffering, neurosurgical operation, comitiality, stroke...)
  • Presence of joint pain, likely to worsen after exercise
  • \- Substance use disorders (as defined by DSM-IV TR)
  • D vision disorders as measured by the Wirt stereotest (depth perception at a disparity of at least 80'' arc)
  • Movement perception disorders (correct movement discrimination in less than 75% of trials (cf. § V-2.2)
  • History of general anaesthesia in the 3 months preceding the study
  • History of neurological disease
  • Impossibility of giving the subject informed information (subject in emergency situation)
  • Pregnancy declared by patient
  • Breast-feeding
  • Subject hospitalized
  • Subject under court protection
  • History of major psychiatric pathology with current psychotropic medication (i.e., antidepressant, thymoregulator, antipsychotic)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de psychiatrie

Strasbourg, 67000, France

Location

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

Exercise

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Marius Teletin, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2024

First Posted

February 10, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

August 6, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations