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The Effects of Three Different Modalities of Exercise in Patients With Schizophrenia (E-S)

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Experimental-Exercise 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 Type

Experimental

Experimental

Experimental

Arm Label

Experimental-Strength training

Experimental-Aerobic training

Experimental-Strength/Aerobic training

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.

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
May 15, 2019
Last Updated
June 27, 2021
Sponsor
Cardenal Herrera University
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1. Study Identification

Unique Protocol Identification Number
NCT03953664
Brief Title
The Effects of Three Different Modalities of Exercise in Patients With Schizophrenia
Acronym
E-S
Official Title
The Effects of Three Different Modalities of Exercise Training (Aerobic, Strength, Aerobic-strength) on Psychological and Physiological Correlates in Schizophrenia: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 14, 2020 (Actual)
Primary Completion Date
April 1, 2021 (Actual)
Study Completion Date
April 1, 2021 (Actual)

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
Exercise has been shown to improve health in patients with schizophrenia. However, it remains unclear which modality of exercise reports better benefits. Aim: To compare the effects of different modalities of exercise training on psychological and physiological variables in schizophrenia.
Detailed Description
Exercise has been shown to improve psychological, physiological, and biological correlates in patients with schizophrenia. However, it remains unclear which modality of exercise reports better health benefits. Aim: To compare the effects of three different modalities of exercise (aerobic, strength, aerobic-strength) on psychological and physiological variables in patients with schizophrenia. Design: Randomized clinical trial

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
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental-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
Experimental-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
Experimental-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.
Intervention Type
Other
Intervention Name(s)
Experimental-Exercise 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 or/and aerobic training exercises.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JF Lisón, PhD
Organizational Affiliation
Cardenal Herrera University
Official's Role
Study Director
Facility Information:
Facility Name
Universidad CEU Cardenal Herrera
City
Moncada
State/Province
Valencia
ZIP/Postal Code
46113
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.

Learn more about this trial

The Effects of Three Different Modalities of Exercise in Patients With Schizophrenia

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