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

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ClinicalTrials.gov Identifier: NCT03953664
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : July 4, 2019
Sponsor:
Information provided by (Responsible Party):
Juan F. Lisón Párraga, Dr, Cardenal Herrera University

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.


Condition or disease Intervention/treatment Phase
Schizophrenia Other: Experimental-Exercise training Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : May 28, 2019
Estimated Primary Completion Date : November 5, 2019
Estimated Study Completion Date : November 14, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental-Strength training
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-Exercise training
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.

Experimental: Experimental-Aerobic training
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-Exercise training
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.

Experimental: Experimental-Strength/Aerobic training
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-Exercise training
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 Measures :
  1. Positive and Negative Syndrome Scale (PANSS) [ Time Frame: 16 weeks ]
    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 :
  1. World Health Organization Quality of Life-Short version (WHOQOL-BREF) [ Time Frame: 16 weeks ]
    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.

  2. Body Mass Index (BMI) [ Time Frame: 16 weeks ]
    The BMI is defined as the body mass divided by the square of the body height.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03953664


Contacts
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Contact: JF Lisón, PhD 961369000 ext 64349 juanfran@uchceu.es
Contact: Loreto Peyró, PhD 961369000 ext 64311 lpeyro@uchceu.es

Locations
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Spain
Universidad CEU Cardenal Herrera Recruiting
Moncada, Valencia, Spain, 46113
Contact: JF Lisón, PhD    961369000    juanfran@uchceu.es   
Sponsors and Collaborators
Cardenal Herrera University
Investigators
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Study Director: JF Lisón, PhD Cardenal Herrera University

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Responsible Party: Juan F. Lisón Párraga, Dr, Head of Medicine, Cardenal Herrera University
ClinicalTrials.gov Identifier: NCT03953664     History of Changes
Other Study ID Numbers: UNIVERSITY CARDENAL HERRERA-22
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders