Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07360665

Multimodal Physical Exercise Program (Physical Exercise for Psychosis) for People With Psychosis 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

47 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, such as schizophrenia, often experience significant difficulties in daily functioning, physical health, and quality of life. Long-acting injectable antipsychotics are an important part of treatment, but they can be associated with metabolic side effects and reduced physical fitness. Physical exercise has shown potential benefits for mental and physical health in this population; however, structured exercise programs implemented in real-world psychiatric services are still limited. The purpose of this study is to evaluate the feasibility and clinical impact of a structured, multimodal physical exercise program for adults with psychosis who are receiving long-acting injectable antipsychotic treatment. The study aims to determine whether participation in a supervised exercise program can improve physical functioning, psychological well-being, and selected biological markers related to brain health and metabolism. This study will be conducted in an outpatient psychiatric setting in Portugal and will include adults diagnosed with psychosis who are currently treated with long-acting injectable antipsychotics. Participants will be allocated to either an exercise group or a control group receiving usual care. The exercise program will last 24 weeks and will include aerobic, strength, mobility, and flexibility exercises, with supervised sessions conducted by qualified professionals. Participants will be assessed at baseline, during the intervention, after completion of the program, and at follow-up. Assessments will include measures of physical function, body composition, psychological well-being, quality of life, and blood-based biomarkers such as brain-derived neurotrophic factor, dopamine, serotonin, and metabolic indicators. The main hypothesis of this study is that individuals who participate in the physical exercise program will show improvements in physical function, mood, and overall well-being compared with those receiving usual care alone. The results of this study are expected to provide practical evidence to support the integration of structured physical exercise as an adjunct to routine psychiatric care for people with psychosis.

CONDITIONS

Official 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 from treating psychiatrist confirming capacity 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 (LAIs)
  • 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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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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Multimodal Physical Exercise Program (Physical Exercise for Psychosis) for People With Psychosis Treated With Long-Acting Injectable Antipsychotics | DecenTrialz