RecruitingNot ApplicableNCT07360665

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

PEP - Physical Exercise for Psychosis: A Study Protocol


Sponsor

University of Trás-os-Montes and Alto Douro

Enrollment

44 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a structured multimodal exercise program designed for people with psychosis who are receiving long-acting injectable antipsychotic medications, to see if regular physical activity improves their mental and physical health. **You may be eligible if...** - You are 18 or older - You have a clinical diagnosis of psychosis - You are currently being treated with long-acting injectable antipsychotic medication - You are followed at the Antipsychotic Clinic of ULSTMAD (Portugal) - Your psychiatrist has confirmed that you can safely participate - You are able to give written consent (or have a legal representative do so) **You may NOT be eligible if...** - You are not on long-acting injectable antipsychotics - You are not followed at the ULSTMAD clinic - You are unable or unwilling to complete all four assessment time points - For the exercise group specifically: you live too far from the exercise site to attend sessions regularly Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERPhysical Exercise

The program will be multimodal, integrating various exercise components. The aerobic component will consist of activities like walking, cycling, and circuit training. The functional strength component will include 2 to 3 exercises for the lower limbs, 2 to 3 exercises for the upper limbs, 1 to 2 exercises for the trunk and abdominal muscles, as well as 1 to 2 multi-joint exercises like burpees, swing kettlebell, among others. Lastly, the program will also incorporate mobility, balance, and flexibility exercises, such as stretching, postures, and joint mobilization.


Locations(1)

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

Vila Real, Portugal

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NCT07360665


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