Schizophrenia Clinical Trial
Official title:
Schizophrenia and Physical Exercise: Effect of 20 Weeks of Training in Symptoms and Concentration in Serum IGF-1 and BDNF
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05039489 -
A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia
|
N/A | |
Completed |
NCT05111548 -
Brain Stimulation and Cognitive Training - Efficacy
|
N/A | |
Completed |
NCT05321602 -
Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder
|
Phase 1 | |
Completed |
NCT04503954 -
Efficacy of Chronic Disease Self-management Program in People With Schizophrenia
|
N/A | |
Completed |
NCT02831231 -
Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium
|
Phase 1 | |
Completed |
NCT05517460 -
The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center
|
N/A | |
Completed |
NCT03652974 -
Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy
|
Phase 4 | |
Recruiting |
NCT04012684 -
rTMS on Mismatch Negativity of Schizophrenia
|
N/A | |
Recruiting |
NCT04481217 -
Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia
|
N/A | |
Completed |
NCT00212784 -
Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935)
|
Phase 3 | |
Completed |
NCT04092686 -
A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
|
Phase 3 | |
Completed |
NCT01914393 -
Pediatric Open-Label Extension Study
|
Phase 3 | |
Recruiting |
NCT03790345 -
Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics
|
Phase 2/Phase 3 | |
Recruiting |
NCT05956327 -
Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training
|
N/A | |
Terminated |
NCT03261817 -
A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders
|
N/A | |
Terminated |
NCT03209778 -
Involuntary Memories Investigation in Schizophrenia
|
N/A | |
Completed |
NCT02905604 -
Magnetic Stimulation of the Brain in Schizophrenia or Depression
|
N/A | |
Recruiting |
NCT05542212 -
Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia
|
N/A | |
Completed |
NCT04411979 -
Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia
|
N/A | |
Terminated |
NCT03220438 -
TMS Enhancement of Visual Plasticity in Schizophrenia
|
N/A |