Schizophrenia Clinical Trial
Official title:
Comparison of Three Different Exercise Training Modalities (Aerobic, Strength, and Mixed) in Patients With Schizophrenia: Study Protocol for a Multi-centre Randomised Wait-list Controlled Trial
Introduction: Numerous studies support the practice of different physical exercise modalities as an effective treatment to address the different problems associated with schizophrenia, reporting that they result in significant improvements in patient symptoms and quality of life. Given the lack of studies comparing different types of training in controlled environments, the aim of this proposed study will be to compare the effects of three physical exercise programs (strength, aerobic, and mixed) on the symptoms, body composition, level of physical activity, and health-related quality of life of patients with schizophrenia. Ethics and dissemination: This study was approved by the ethics committees for Biomedical Research at the CEU Cardenal Herrera University of Valencia in Spain (reference number: CEI18/215). Participants will be fully informed of the purpose and procedures of the study, and written informed consent will be obtained from every participant. The results from this study will be published in peer-reviewed journals and presented in scientific conferences.
Status | Not yet recruiting |
Enrollment | 105 |
Est. completion date | July 2022 |
Est. primary completion date | January 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Diagnosis of Schizophrenia - Age between 18-65 years Exclusion Criteria: - Patients with other mental diseases - Patients with mental disabilities - Patients who present motor or behavioral pathologies that prevent the realization of the exercise training. |
Country | Name | City | State |
---|---|---|---|
Spain | Universidad CEU-Cardenal Herrera | Valencia |
Lead Sponsor | Collaborator |
---|---|
Cardenal Herrera University |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Positive and Negative Syndrome Scale (PANSS) | Symptoms of schizophrenia are measured according to the subscale scores and total score on the PANSS which consists of 30 items scored from 1 (Absent) to 7 (Extreme). Scores range from 30 to 210, with higher scores indicating more symptoms | 16 weeks | |
Secondary | World Health Organization Quality of Life-Short version (WHOQOL-BREF) | The WHOQOL-BREF contains 24 questions covering 4 domains plus two questions related to overall quality of life and satisfaction with health. Highes scores represent higher quality of life. | 16 weeks | |
Secondary | Body Mass Index (BMI) | The BMI is defined as the body mass divided by the square of the body height. | 16 weeks |
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