Schizophrenia and Physical Exercise

NCT01595698 | Completed DMC

• 1 other identifier: ESQ-001
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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, 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, aerobic 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.

Conditions

Schizophrenia

Keywords

Physical exercise; IGF-1; Schizophrenia; neuroplasticity

Outcome Measures

Primary Outcomes (1)

• The Positive and Negative Syndrome Scale (PANSS)

  This scale consists of 18 items from the Brief Psychiatry Rating Scale (BPRS) and 12 items from the Psychopathology Rating Scale. Strict criteria were defined for the 30 symptoms, and scores from 1 to 7 were given for each of the seven psychopathology severity levels. Item selection was guided by three main presumptions: 1) the items should be consistent with the theoretical consensus of positive/negative typology; 2) unambiguous symptoms thought to be primary symptoms should be included; and 3) the validity of the content should be optimized.

  up to 20 weeks

Secondary Outcomes (2)

• Calgary Depression Ratio Scale

  up to 20 weeks

• Serum IGF-1

  up to 20 weeks

Study Arms (2)

Control

SHAM COMPARATOR

Other: Control

Physical Exercise

EXPERIMENTAL

Other: Physical Exercise

Interventions

Physical Exercise OTHER

The patients in this group will given a progressive resistance training program twice per week (Tuesday and Thursday) for 20 weeks. The training program followed the American College of Sports Medicine guidelines on resistance training for adults. Training sessions will performed at the same time of day (between 1 pm and 5 pm). The chosen exercises focused on the large muscle groups that are important for the patients' daily routines. The exercises include the leg press, leg curl, vertical traction, chest press, arm extension, arm curl and abdominal crunch using equipment manufactured by Technogym®. Every training session will preceded by 5 minutes of warm-up on a Life Fitness® motorized stepper at a constant velocity of 4 km/h. A 1 RM test will be to determine the load settings, as performed in previous studies. The load will readjusted throughout training according to the results of a 1 RM test after the 2nd month of training (the 8th week of training) for each exercise.

Physical Exercise

Control OTHER

Patients in this group will to the CEPE twice per week (Tuesday and Thursday) for 20 weeks and performed the same training protocol as the RESEX group. However, the equipment load (weight on each apparatus) is kept at the minimum (below 5% of 1 Repetition maximum - RM) throughout the treatment, without modifying the protocol. Patients execute 2 sets of 15 repetitions with a 1-minute rest interval on all of the equipment.

Control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• type 1 or type 2 diabetes mellitus
• cardiovascular disease
• obesity
• drug and alcohol abuse

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Psychology and Exercise Studies Centre

São Paulo, São Paulo, 04020-050, Brazil

Location

MeSH Terms

Conditions

Schizophrenia; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Marco Tulio de Mello

  Universidade Federal de São paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Professor

Study Record Dates

• First Submitted: April 25, 2012
• First Posted: May 10, 2012
• Study Start: February 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: June 12, 2012

Record last verified: 2012-06

Locations

BR (1)