The Effects of Different Modalities of Exercise in Patients With Schizophrenia

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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. A multicentre, single-blinded (evaluator), randomised, wait-list controlled (ratio 2:2:2:1) trial will be conducted with 105 patients recruited from different psychosocial care centres. The participants will be randomised into three 16-week training groups comprising 48 sessions lasting one hour each, or to the wait-list control group. The training groups will complete aerobic, strength, or mixed (aerobic + strength) training. The participants will be assessed before, immediately after, and 6 months after the end of the intervention. All the patients in the wait-list control group (n = 15) will receive one of the three trainings immediately after the intervention. The study variables will include positive symptomatology, negative symptomatology, and general symptomology (using the Positive and Negative Syndrome Scale) as the primary outcome; as secondary outcome: body composition (by assessing body mass index, body fat mass and waist circumference), physical activity levels (International Physical Activity Questionnaire-Short Form), and quality of life (abbreviated World Health Organization Quality of Life questionnaire).

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

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Other: Experimental-Strength training
* Other: Experimental-Aerobic training
* Other: Experimental-Strength/Aerobic training


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Strength training<br>Each session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching) and 40 minutes are allocated to strength training exercise involving the major muscle groups. | Other: Experimental-Strength training<br>* Each session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching) and 40 minutes are allocated to strength training exercise involving the major muscle groups<br>|
| Experimental: Aerobic training<br>Each session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching) and 40 minutes are allocated to brisk walking, | Other: Experimental-Aerobic training<br>* Each session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching) and 40 minutes are allocated to brisk walking.<br>|
| Experimental: Strength/Aerobic training<br>Each session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching), 15 minutes are allocated to brisk walking and 25 minutes are allocated to strength training involving the major muscle groups | Other: Experimental-Strength/Aerobic training<br>* Each session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching), 15 minutes are allocated to brisk walking and 25 minutes are allocated to strength training involving the major muscle groups.<br>|
| No Intervention: Control Group<br>All the patients in the wait-list control group will receive one of the three trainings immediately after the intervention. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Body Mass Index (BMI) | The BMI is defined as the body mass divided by the square of the body height. | 16 weeks |