Adapted Physical Activity Program for Patients Undergoing Antipsychotic Treatment of a First Episode of Psychosis

NCT06643871 | Not Yet Recruiting

• 1 other identifier: D23-P009
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this PILOT feasibility study is to verify the acceptability, feasibility, and compliance to the DYNAMO-PSY program among young adults treated with antipsychotics for a first episode of psychosis (FEP). Our hypothesis is that the use of an immersive program of APA, including an EE with VR (connected bikes), will allow good observance to regular physical activity in patients treated with antipsychotics for a FEP. This regular practice of physical activity will prevent the onset of weight gain and metabolic syndrome. In addition, a positive effect on self-esteem, overall and particularly cognitive functioning, quality of life, and adherence to antipsychotic treatment can be expected.\"

Conditions

Schizophrenia; Psychosis; Schizo Affective Disorder; First Episode Psychosis (FEP)

Keywords

Schizophrenia; Adapted physical activity; Early Intervention; First Episode psychosis; Metabolic Syndrom

Outcome Measures

Primary Outcomes (1)

• Completion rate of the DYNAMO-PSY program

  The main objective will be to assess the completion rate of the dynamopsy program. Then, the primary outcome measure will be the completion of the program by the participant (Yes/No). For each patient included in the study, the number of sessions completed will be recorded. The DYNAMO-PSY program consists of 20 sessions in total. The DYNAMO-PSY program is considered completed when the patient has completed 20 sessions (otherwise, the program is considered abandoned). The completion rate to the DYNAMO-PSY program will be calculated as the proportion : number of patients who completed the program / number of patients included in the study.

  From enrollment to the end of the program at 15 weeks

Secondary Outcomes (33)

• Social and Occupational Functioning

  at enrollment and at 15 weeks

• Global Functionning

  at enrollment and at 15 weeks

• Executive functions - Inhibition

  at the enrollment and at 15 weeks

• Executive functions : Cognitive flexibility

  at the enrollment and at 15 weeks

• Executive functions - symptoms inventory

  at the enrollment and at 15 weeks

Study Arms (1)

DYNAMO-PSY program

EXPERIMENTAL

This is a feasibility study. Therfore, there is only one arm, the experimental one, where participants will be enrolled in the DYNAMO-PSY program.

Other: Adapted physical activity program involving connected bikes

Interventions

Adapted physical activity program involving connected bikes OTHER

The treatment being studied involves a program (DYNAMO-PSY) of adapted physical activity with an enriched environment (connected bike, visualized and experienced routes in virtual reality) and is supervised, comprising (on average) two sessions per week, a total of 20 sessions to be completed over a maximum of 15 weeks. Each session will last 60 minutes and will be supervised by a case manager. They will be composed of a warm up, session on the bike (around 30 minutes of bicycling) and stretching. They will take place in an adequate room in the clinical research department of Saint Anne Hospital. The usual hygienic-dietetic care is not modified by the study and consists of the care proposed to patients of the GHU Paris Psychiatry and Neuroscience who have had a first psychotic episode and are treated primarily with medication: clinical and biological monitoring, dietary consultations, therapeutic education group concerning diet and lifestyle.

DYNAMO-PSY program

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- Patient suffering or having suffered from a FEP, corresponding to the criteria of brief psychotic episode or schizoaffective disorder in the DSM-5, within the last two years.
• Or suffering from schizophrenia or a schizoaffective disorder, evolving for less than two years.
• Aged 18 to 30 years.
• Male or female.
• inpatient or outpatient.
• Treated with antipsychotic (typical or atypical).
• Willing to participate in the study and having signed the informed consent form after oral and written information.
• Affiliated or beneficiary of a health insurance scheme.

You may not qualify if:

• Patient not fluent in French.
• Patient in detention or under protective measures.
• Patient hospitalized without consent
• Medical contraindication to cycling (notably ventricular arrhythmia, or prolonged QT interval), validated by a medical opinion.
• Known epilepsy.
• Pregnant or breastfeeding women.
• Specific Contraindications to Virtual Reality:
• High susceptibility to motion sickness.
• Vestibular disorders.
• Anomalies in postural statics and/or dynamic balance with proprioception disorders.
• Uncorrected ocular or oculomotor disorders.
• Frequent migraines.
• Severe anxiety

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Raphaëlle LEROUX AUGER, DR

  Pôle PEPIT - Centre d évaluation pour Jeunes Adultes et Adolescents (CJAAD)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raphaëlle LEROUX AUGER, DR

CONTACT

+33 145 652 130; r.leroux_auger@ghu-paris.fr

ALEXANDRA PHAM, DR

CONTACT

01 45 65 83 70; A.PHAM@ghu-paris.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: October 16, 2024
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 16, 2024

Record last verified: 2024-02