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

Официальное название

PEP - Physical Exercise for Psychosis: A Study Protocol

Обзор

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.

Вмешательства

• Другое Physical 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 flexi

Первичные конечные точки

• Body mass/weight [Срок оценки: Baseline, 12 weeks, 24 weeks, 8-week post-intervention follow-up]
• Body mass index (BMI) [Срок оценки: Baseline, 12 weeks, 24 weeks, 8-week post-intervention follow-up]
• Body fat percentage [Срок оценки: Baseline, 12 weeks, 24 weeks, 8-week post-intervention follow-up]
• Lean body mass [Срок оценки: Baseline, 12 weeks, 24 weeks, 8-week post-intervention follow-up]
• Sit-to-Stand Test _ 30s [Срок оценки: Baseline, 12 weeks, 24 weeks, and 8-week post-intervention follow-up]
• Handgrip Test [Срок оценки: Baseline, 12 weeks, 24 weeks, and 8-week post-intervention follow-up]
• European Health Interview Survey - Quality of Life 8-item Index (EUROHIS-QOL-8) [Срок оценки: Baseline, 12 weeks, 24 weeks, and 8-week post-intervention follow-up]
• Patient Health Questionnaire-9 - PHQ-9 [Срок оценки: Baseline, 12 weeks, 24 weeks, and 8-week post-intervention follow-up]
• Positive and Negative Affect Scale (PANAS) [Срок оценки: Baseline, 12 weeks, 24 weeks, and 8-week post-intervention follow-up]
• Serum Brain-Derived Neurotrophic Factor (BDNF) levels [Срок оценки: Baseline, 12 weeks, 24 weeks, and 8-week post-intervention follow-up]

Вторичные конечные точки (1)

• Height [Срок оценки: Baseline]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Португалия · 1 центр

• Local Health Unit of Trás-os-Montes and Alto Douro — Vila Real

Идентификаторы

NCT: NCT07360665 · 2024.04489.BDANA · CES REG. 1612

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗