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.
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;
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);
Parallel
Physical Exercise
Other interventionThe 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.
Body mass/weight
Body mass/weight measured in kilograms using a calibrated scale.
Body mass index (BMI)
BMI calculated as weight (kg) / height (m²)
Body fat percentage
Body fat percentage assessed by electrical bioimpedance analysis
Lean body mass
Lean body mass (kg) assessed by electrical bioimpedance analysis
Height
Height measured in meters using stadiometer (baseline only, if applicable)
Sociodemographic Characterization
The sociodemographic characterization of participants will be performed using a structured questionnaire designed to collect information on variables such as age, gender, marital status, education, employment status, and family context. This instrument provides a comprehensive description of the sample profile and enables the analysis of potential sociodemographic factors associated with the clinical and functional variables under study.
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University of Trás-os-Montes and Alto Douro
Lead sponsor
Centro Hospitalar De Trás-Os-Montes E Alto Douro, E.P.E.
Collaborator
