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The Effects of Different Modalities of Exercise in Patients With Schizophrenia

Primary Purpose

Schizophrenia

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Experimental-Strength training
Experimental-Aerobic training
Experimental-Strength/Aerobic training
Sponsored by
Cardenal Herrera University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidad CEU-Cardenal Herrera

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Strength training

Aerobic training

Strength/Aerobic training

Control Group

Arm Description

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.

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,

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

All the patients in the wait-list control group will receive one of the three trainings immediately after the intervention.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Body Mass Index (BMI)
The BMI is defined as the body mass divided by the square of the body height.

Full Information

First Posted
July 19, 2021
Last Updated
July 23, 2021
Sponsor
Cardenal Herrera University
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1. Study Identification

Unique Protocol Identification Number
NCT04987151
Brief Title
The Effects of Different Modalities of Exercise in Patients With Schizophrenia
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 2021 (Anticipated)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardenal Herrera University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Strength training
Arm Type
Experimental
Arm Description
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.
Arm Title
Aerobic training
Arm Type
Experimental
Arm Description
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,
Arm Title
Strength/Aerobic training
Arm Type
Experimental
Arm Description
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
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
All the patients in the wait-list control group will receive one of the three trainings immediately after the intervention.
Intervention Type
Other
Intervention Name(s)
Experimental-Strength training
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Experimental-Aerobic training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Experimental-Strength/Aerobic training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Positive and Negative Syndrome Scale (PANSS)
Description
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
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
World Health Organization Quality of Life-Short version (WHOQOL-BREF)
Description
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.
Time Frame
16 weeks
Title
Body Mass Index (BMI)
Description
The BMI is defined as the body mass divided by the square of the body height.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura García Garcés, Dr.
Phone
96 136 90 00
Ext
64352
Email
lauragarciagarcesphd@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
María Inmaculada Sánchez López, Dr
Phone
96 136 90 00
Ext
64535
Email
maria.sanchez6@uchceu.es
Facility Information:
Facility Name
Universidad CEU-Cardenal Herrera
City
Valencia
ZIP/Postal Code
46115
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual deidentified participant data will be available to other researchers.
IPD Sharing Time Frame
Inmediately following publication.
Citations:
PubMed Identifier
34535474
Citation
Garcia-Garces L, Lacamara Cano S, Cebolla Melia Y, Sanchez-Lopez MI, Marques Azcona D, Lison JF, Peyro-Gregori L. Comparison of three different exercise training modalities (aerobic, strength and mixed) in patients with schizophrenia: study protocol for a multicentre randomised wait-list controlled trial. BMJ Open. 2021 Sep 17;11(9):e046216. doi: 10.1136/bmjopen-2020-046216.
Results Reference
derived

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The Effects of Different Modalities of Exercise in Patients With Schizophrenia

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