Clinical trial NCT03714698: Effects of Pilates Exercise Program in Patients With Schizophrenia
Official title: Effects of Pilates-based Exercises on Functional Capacity and Mental Health in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Pilates exercise
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2018-10-22
Enrollment: 25
Sex: ALL
Minimum age (years): 35
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilates exercise group participated in supervised Pilates-based group training twice per week for six weeks, while the control group participated in a routine non-specific activity program twice a week in Community Mental Health Center during study
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Schizophrenia is one of the most frequent psychiatric disorders with a prevalence of 0.5-1.0 % all over the world. It remains one of the major reasons for disability although medical and psychosocial interventions.

People suffering from schizophrenia may also have many complex health troubles such as cardiovascular disease, metabolic disease, diabetes mellitus, and pulmonary problems.

Researchers have been debating the utility of exercise over depression, anxiety, and obsessive-compulsive symptoms last decades. Studies indicate that physical activity improves mood, self-esteem, energy, motivation, concentration, cognitive skills, quality of life, and social interactions. Particularly in the last decade studies have been carried out showing that various exercise approaches and physical activities contribute positively to the physical and mental health of schizophrenic patients. Clinic impacts of these interventions, dominantly including aerobic exercise, strengthening and fitness training, also varied according to the type, duration and intensity of the method used.

The knowledge obtained about schizophrenia patients point out that physically and mentally holistic approaches should be required to this complicated disease. Previous trials demonstrated that various physical activity or exercise methods have positive effects in patients with schizophrenia. However, to the best of the our knowledge, literature lacks investigation about benefits of Pilates on several domains, in particular about the potential changes on physical and mental health in patients with schizophrenia. The aim of this study was to investigate the effects of Pilates-based exercise training on the physical and mental health of schizophrenia patients.

Detailed description: Pilates exercises developed by Joseph Pilates has an increasing popularity in last decades. Pilates supposed that the balance between body and mind is an important factor in achieving health and happiness. Pilates stimulates the mind and decreases mental strain. The basic principles of Pilates-based approach are concentration, control, centering, diaphragmatic breathing, lightness, precision, and relaxation. It also aims to enlighten the awareness of body by inducing mind control. The control of large group muscles with coordination and focusing on breathing may increase aerobic capacity, and further improves mental health. Heretofore, some researchers also reported that the holistic approach of Pilates-based training may provide physical and psychological improvements on human health, and various intensities benefit the quality of life, mental health, physical fitness levels, and body types. Pilates exercises are utilized with a wide range spectrum for many diseases' management and are particularly used also for mental health disease such as depression, anxiety, mood etc. The sample of the study consisted of patients who were diagnosed with schizophrenia according to The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). Current study was conducted in accordance with the Helsinki Declaration and its subsequent amendments. All the subjects volunteered to participate in this research and signed the informed consent form approved by the Institutional Clinical Research Ethics Committee (Protocol no: 2015-84-21/10). On receipt of a completed consent form, patients were assigned to Pilates exercise group (PEG) or control group (CG) based on their willingness.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria were having symptoms of schizophrenia for at least six months, not to change the type of antipsychotic medication prescribed for at least six weeks prior to study (although dosage might change).

Exclusion Criteria:

* Patients with a severe physical disability or a physical condition that makes their participation impossible or potentially harmful (such as serious musculoskeletal or neurological disabilities) were excluded from the study. Additionally, patients who did not attend at least 10 of the 12 training sessions in the study group were excluded from the study.

Primary outcomes:
measure: Change from baseline "6 Minute Walk Test" at 6 week
timeFrame: at the baseline and after six weeks
Secondary outcomes:
measure: Change from baseline Calgary Depression Scale for Schizophrenia at 6 week
timeFrame: at the baseline and after six weeks
measure: Change from baseline The Scale for the Assessment of Negative Symptoms at 6 week
timeFrame: at the baseline and after six weeks
measure: Change from baseline The Scale for the Assessment of Positive Symptoms (SAPS) at 6 week
timeFrame: at the baseline and after six weeks
measure: Change from baseline The Brief Psychiatric Rating Scale at 6 week
timeFrame: at the baseline and after six weeks
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Zonguldak Bülent Ecevit University
Study officials:
affiliation: Zonguldak Bulent Ecevit University
name: Eda AKBAŞ, Assist.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Rimes RR, de Souza Moura AM, Lamego MK, de Sa Filho AS, Manochio J, Paes F, Carta MG, Mura G, Wegner M, Budde H, Ferreira Rocha NB, Rocha J, Tavares JM, Arias-Carrion O, Nardi AE, Yuan TF, Machado S. Effects of Exercise on Physical and Mental Health, and Cognitive and Brain Functions in Schizophrenia: Clinical and Experimental Evidence. CNS Neurol Disord Drug Targets. 2015;14(10):1244-54. doi: 10.2174/1871527315666151111130659.
citation: Oertel-Knochel V, Mehler P, Thiel C, Steinbrecher K, Malchow B, Tesky V, Ademmer K, Prvulovic D, Banzer W, Zopf Y, Schmitt A, Hansel F. Effects of aerobic exercise on cognitive performance and individual psychopathology in depressive and schizophrenia patients. Eur Arch Psychiatry Clin Neurosci. 2014 Oct;264(7):589-604. doi: 10.1007/s00406-014-0485-9. Epub 2014 Feb 2.
citation: Firth J, Cotter J, Elliott R, French P, Yung AR. A systematic review and meta-analysis of exercise interventions in schizophrenia patients. Psychol Med. 2015 May;45(7):1343-61. doi: 10.1017/S0033291714003110. Epub 2015 Feb 4.