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.

adult psychiatry clinical trials education & training (see medical education & training) schizophrenia & psychotic disorders

Journal

BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874

Informations de publication

Date de publication:
17 09 2021
Historique:
entrez: 18 9 2021
pubmed: 19 9 2021
medline: 21 10 2021
Statut: epublish

Résumé

Numerous studies support the practice of different physical exercise modalities as an effective treatment to address the problems associated with schizophrenia, reporting that they result in 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 programmes (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 1 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. 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, negative and general symptomology (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 WHO Quality of Life questionnaire). This study was approved by the ethics committees for Biomedical Research at the CEU Cardenal Herrera University of Valencia, Spain (CEI18/215). Participants will be fully informed of the purpose and procedures of the study, and written informed consent will be obtained. The results from this study will be published in peer-reviewed journals and presented in scientific conferences. NCT04987151.

Identifiants

pubmed: 34535474
pii: bmjopen-2020-046216
doi: 10.1136/bmjopen-2020-046216
pmc: PMC8451286
doi:

Banques de données

ClinicalTrials.gov
['NCT04987151']

Types de publication

Clinical Trial Protocol Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

e046216

Informations de copyright

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: None declared.

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Auteurs

Laura García-Garcés (L)

Department of Nursing and Physiotherapy, Faculty of Health Sciences, Universidad Cardenal Herrera-CEU,CEU Universities, Moncada, Valencia, Spain lauragarciagarcesphd@gmail.com.

Sergio Lacamara Cano (S)

Department of Universal Health and Public Health, Valencia, Spain.

Yago Cebolla Meliá (Y)

Department of Universal Health and Public Health, Valencia, Spain.

María I Sánchez-López (MI)

Department of Nursing and Physiotherapy, Faculty of Health Sciences, Universidad Cardenal Herrera-CEU,CEU Universities, Moncada, Valencia, Spain.

David Marqués Azcona (D)

Vice Presidency and Ministry of Equality and Inclusive Policies, Valencia, Spain.

Juan Francisco Lisón (JF)

Department of Biomedical Science, Faculty of Health Sciences, Universidad Cardenal Herrera-CEU,CEU Universities, Moncada, Valencia, Spain.
Centre of Networked Biomedical Research in the Physiopathology of Obesity and Nutrition (CIBERobn), CB06/03, Carlos III Health Institute, Madrid, Spain.

Loreto Peyró-Gregori (L)

Department of Nursing and Physiotherapy, Faculty of Health Sciences, Universidad Cardenal Herrera-CEU,CEU Universities, Moncada, Valencia, Spain.

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