Multimodal physical exercise program for people with psychosis on long-acting injectable antipsychotics

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with psychotic disorders who are treated with long‑acting injectable antipsychotics and followed at the ULSTMAD Antipsychotic Clinic will be recruited into an outpatient multimodal exercise program combining aerobic and resistance training with supervised sessions and adherence monitoring. Key outcomes—physical functioning, psychological well‑being, and selected biological markers linked to brain health and metabolism—will be measured at four main time points. The intervention arm participants must be able to attend supervised sessions locally and meet a predefined adherence threshold, with feasibility and clinical impact assessed in a real‑world psychiatric service setting. Results will inform whether this structured program can be integrated into routine care and guide larger trials.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 years or older;
* Clinical diagnosis of psychosis;
* Currently undergoing treatment with long-acting injectable antipsychotics (LAIs);
* Follow-up at the Antipsychotic Clinic of ULSTMAD;
* Certificate of autonomy issued by the treating psychiatrist, confirming the participant's capacity to engage in the study procedures;
* Ability to provide written informed consent, either personally or through a legal representative;
* (Experimental group only) Residence within a reasonable distance from the physical exercise intervention site to allow attendance at supervised sessions.

Exclusion Criteria:

* Attendance below 85% of the supervised exercise sessions (experimental group);
* Failure to complete the four main assessment time points;
* Withdrawal or lack of informed consent at any stage of the study;
* Not prescribed long-acting injectable antipsychotics (LAIs);
* Not affiliated with or followed at the Antipsychotic Clinic of ULSTMAD.

Where it's running

• Local Health Unit of Trás-os-Montes and Alto Douro
  Vila Real, Portugal Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.