Clinical trial NCT01674543: Clinical Symptoms of Schizophrenia and Physical Exercise
Official title: Schizophrenia and Physical Exercise: Effect of 20 Weeks of Training in Symptoms and Concentration in Serum IGF-1 and BDNF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Physical exercise
Schizophrenia
symptoms
IGF-1
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2012-08-29
Enrollment: 47
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Schizophrenia is a severe mental illness, of psychosis being the most prevalent in society, affecting 1% of the population. The treatment of schizophrenia is basically done with antipsychotic drugs, although other non-pharmacological interventions, such as exercise, a form of treatment seems to be considered. Among the most recommended exercise for the general population, the investigators highlight the aerobic and resistance exercises. However, few studies have reported the positive effect of aerobic exercise in the pathogenesis of schizophrenia. In relation to resistance exercise and concurrent training, it is unknown if the effect in patients with the disease, especially when one considers the junction of the two types of exercises in the same training session (called concurrent training). However, it is known, through clinical studies and animal models, that exercise modifies the brain improves neuroplasticity, the mental condition of the individual frames and reverses neurodegeneration. Associated with improvement in schizophrenia, few clinical trials of aerobic exercise showed improvement in disease symptoms, reducing anxiety and depression, and clinical global improvement. The hypothesis is that the types of proposed training, resistance training and concurrent training can improve clinical symptoms of the disease, and improve the side effects caused by drugs. It is believed that the clinical changes are accompanied by increased serum IGF-1 by resistance training and aerobic training by BDNF.

Detailed description: Schizophrenia is a serious mental disease characterized by a combination of positive and negative symptoms, and it is associated with social and occupational dysfunction. The positive symptoms reflect an excess or distortion of normal functions (delusions, hallucinations and disorganized behavior), whereas the negative symptoms are related to flattened affect, alogia, avolition and decreased cognitive function. One recent study reported that schizophrenia is associated with distortions of reality, changes in perceptions and thoughts, difficulties in social situations and problems with daily functions.

Schizophrenia generally appears at the end of adolescence or at the beginning of adulthood and affects approximately 1% of the population. The disease has a deteriorating course and does not involve large neurological changes. Its etiology may be explained by interactions between factors associated with genetic susceptibility and adverse environmental factors. Recently, it has been hypothesized that alterations in neuroplasticity may be an important factor for the development of schizophrenia.

IGF-1 is an important growth factor that induces neuroplasticity (neuronal survival, cell differentiation, cell proliferation, synaptic plasticity and neurogenesis). Schizophrenic patients have lower serum IGF-1 levels than healthy individuals. Because IGF-1 levels are lower in schizophrenic patients and this is associated with the etiology of the disease, it is important to investigate treatments that may increase serum IGF-1. Antipsychotic drugs such as olanzapine stimulate the phosphorylation of AKT, which is part of the main downstream pathway of IGF-1. It is possible to activate AKT through several intracellular signals and receptors, including activation of the insulin receptor (IR). However, activation of the IGF-1 receptor (IGF-1R) appears to be the main activator of AKT phosphorylation.

In addition to antipsychotic medications, resistance exercises may be another way to increase IGF-1 concentrations. This type of physical exercise has been growing in popularity in society. In recent years, evidence has shown benefits from this exercise for different age groups in both healthy and sick individuals, and it has been indicated to augment bone mineral mass, strength and muscular mass; to prevent or treat sarcopenia; to decrease frailty and functional impairment; and to improve cognitive function and hypertension, among other benefits.

Studies conducted with the young and the elderly who underwent resistance training have shown increased serum IGF-1 levels. However, studies showing the effects of resistance training and concurrent training on schizophrenia and serum IGF-1 levels have not been performed. Studying physical exercise is important for several reasons. Importantly, it is a low-cost treatment that may be a possible therapeutic tool, not only to increase IGF-1 concentrations but also to decrease disease symptoms, especially negative symptoms, and the side effects of antipsychotic drugs (extrapyramidal effects, weight gain and tiredness), which may improve quality of life. Therefore, the aim of this study is to evaluate the effects of 20 weeks of resistance training and concurrent training on psychotic and depressive symptoms, quality of life and serum IGF-1 concentration.

Eligibility criteria: Inclusion Criteria:

* diagnosis of paranoid schizophrenia according to DSM-IV
* sedentary lifestyle for more than one year

Exclusion Criteria:

* type 1 or type 2 diabetes mellitus
* cardiovascular disease
* obesity
* Motor or neurological diseases
* drug and alcohol abuse

Primary outcomes:
measure: The Positive and Negative Syndrome Scale (PANSS)
timeFrame: baseline and up to 20 weeks
Secondary outcomes:
measure: Calgary Depression Ratio Scale
timeFrame: baseline and up to 20 weeks
measure: Serum IGF-1
timeFrame: baseline and up to 20 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: CEPE- Centro de Estudo em Psicobiologia e exercício
Study officials:
affiliation: Federal University of São Paulo
name: Marco Tulio de Mello, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Silva BA, Cassilhas RC, Attux C, Cordeiro Q, Gadelha AL, Telles BA, Bressan RA, Ferreira FN, Rodstein PH, Daltio CS, Tufik S, de Mello MT. A 20-week program of resistance or concurrent exercise improves symptoms of schizophrenia: results of a blind, randomized controlled trial. Braz J Psychiatry. 2015 Oct-Dec;37(4):271-9. doi: 10.1590/1516-4446-2014-1595. Epub 2015 Sep 15.