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

NCT03953664 | Completed DMC

• 1 other identifier: UNIVERSITY CARDENAL HERRERA-22
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

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 (3)

Experimental-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-Exercise training

Experimental-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-Exercise training

Experimental-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-Exercise training

Interventions

Experimental-Exercise 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 or/and aerobic training exercises.

Experimental-Aerobic training; Experimental-Strength training; Experimental-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

Moncada, Valencia, 46113, Spain

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• JF Lisón, PhD

  Cardenal Herrera University

  STUDY DIRECTOR

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 Medicine

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 16, 2019
• Study Start: January 14, 2020
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: June 29, 2021

Record last verified: 2021-06

Data Sharing

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

Locations

ES (1)