Multimodal physical exercise program for people with psychosis on long-acting injectable antipsychotics
PEP - Physical Exercise for Psychosis: A Study Protocol
This program will try a supervised, structured exercise course to see if it improves physical fitness, mental well‑being, and metabolic health in adults with psychosis who are on long‑acting injectable antipsychotics.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Trás-os-Montes and Alto Douro Academic / other |
| Locations | 1 site (Vila Real) |
| Trial ID | NCT07360665 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (18+) with a clinical diagnosis of psychosis who are being treated with long‑acting injectable antipsychotics and are followed at the Antipsychotic Clinic of ULSTMAD, who can provide informed consent and (for the intervention) attend supervised sessions locally.
Not a fit: People who are not on long‑acting injectable antipsychotics, are not followed at the ULSTMAD clinic, cannot reliably attend supervised sessions, or who withdraw consent are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the program could improve physical fitness, reduce metabolic side effects, and enhance overall functioning and quality of life for people with psychosis on long‑acting injectables.
How similar studies have performed: Previous research indicates exercise can improve physical health and some psychiatric symptoms in psychosis, but structured multimodal programs delivered within routine outpatient psychiatric services remain relatively undertested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Vila Real
- Local Health Unit of Trás-os-Montes and Alto Douro — Vila Real, Portugal (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.