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

Psychotic Disorders Severe Mental Illness Schizophrenia Spectrum Disorders (SSD)

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

Inclusion Criteria7

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 Criteria5

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.

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.