Adapted Physical Activity Program for Patients Undergoing Antipsychotic Treatment of a First Epis… (NCT06643871) | Clinical Trial Compass
UnknownNot Applicable
Adapted Physical Activity Program for Patients Undergoing Antipsychotic Treatment of a First Episode of Psychosis
40 participantsStarted 2024-12-01
Plain-language 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.\"
Who can participate
Age range
18 Years – 30 Years
Sex
ALL
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:
\- 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.
Exclusion Criteria:
* 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
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
Completion rate of the DYNAMO-PSY program
Timeframe: From enrollment to the end of the program at 15 weeks