The Effects of Different Modalities of Exercise in Patients With Schizophrenia

NCT04987151 | Unknown DMC

• 1 other identifier: UNIVERSITY UCH-CEU
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• World Health Organization Quality of Life-Short version (WHOQOL-BREF)

  16 weeks

• Body Mass Index (BMI)

  16 weeks

Study Arms (4)

Strength training

EXPERIMENTAL

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

Aerobic training

EXPERIMENTAL

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

Strength/Aerobic training

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

Experimental-Strength training OTHER

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

Strength training

Experimental-Aerobic training OTHER

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.

Aerobic training

Experimental-Strength/Aerobic training OTHER

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.

Strength/Aerobic training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Schizophrenia
• Age between 18-65 years

You may not qualify if:

• Patients with other mental diseases
• Patients with mental disabilities
• Patients who present motor or behavioral pathologies that prevent the realization of the exercise training.

Sponsors & Collaborators

• Cardenal Herrera University: lead

Study Sites (1)

Universidad CEU-Cardenal Herrera

Valencia, 46115, Spain

Location

Related Publications (1)

• 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.

  PMID: 34535474 DERIVED

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Laura García Garcés, Dr.

CONTACT

96 136 90 00; lauragarciagarcesphd@gmail.com

María Inmaculada Sánchez López, Dr

CONTACT

96 136 90 00; maria.sanchez6@uchceu.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Nursing and Physiotherapy

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: August 3, 2021
• Study Start: October 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: July 1, 2022
• Last Updated: August 3, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Inmediately following publication.

Locations

ES (1)