Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07360665

Physical Exercise for Psychosis: A Study Protocol Evaluating a Multimodal Physical Exercise Program for Adults Treated with Long-Acting Injectable Antipsychotics

Led by University of Trás-os-Montes and Alto Douro · Updated on 2026-04-29

44

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

Sponsors

U

University of Trás-os-Montes and Alto Douro

Lead Sponsor

C

Centro Hospitalar De Trás-Os-Montes E Alto Douro, E.P.E.

Collaborating Sponsor

AI-Summary

What this Trial Is About

People with psychotic disorders like schizophrenia often face challenges in daily functioning, physical health, and quality of life. This study evaluates the feasibility and impact of a structured, multimodal physical exercise program for adults with psychosis who are treated with long-acting injectable antipsychotics. The goal is to see if supervised exercise can improve physical function, psychological well-being, and biological markers related to brain health and metabolism. Participants will be divided into two groups: one receiving usual care and the other participating in a 24-week supervised exercise program. The exercise includes aerobic activities such as walking and cycling, strength training with exercises targeting different muscle groups, and mobility, balance, and flexibility exercises. Sessions are conducted by qualified professionals in an outpatient psychiatric setting in Portugal. Throughout the study, participants will undergo assessments at baseline, during the program, after completion, and at an 8-week follow-up. These assessments measure physical function, body composition, psychological well-being, quality of life, and blood markers like brain-derived neurotrophic factor, dopamine, serotonin, and metabolic indicators. The study aims to provide evidence for including exercise as part of routine psychiatric care for people with psychosis.

CONDITIONS

Brief Title

Multimodal Physical Exercise Program (Physical Exercise for Psychosis) for People With Psychosis Treated With Long-Acting Injectable Antipsychotics

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 ability to participate
  • Ability to provide written informed consent personally or through a legal representative
  • (Experimental group only) Residence near the exercise intervention site to attend supervised sessions
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Physical Exercise Program

Duration - 24 weeks

Participants in the experimental group engage in a multimodal physical exercise program including aerobic activities, functional strength training, and mobility, balance, and flexibility exercises.

Supervised exercise sessions with frequency not specified

Follow-up

Duration - 8 weeks post-intervention

Participants are monitored for outcomes including body composition, physical function, quality of life, and biochemical markers after the exercise program ends.

1 follow-up visit

Trial Site Locations

Total: 1 location

1

Local Health Unit of Trás-os-Montes and Alto Douro

Vila Real, Portugal, 5000

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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