SchizophreniaNCT01674543
Clinical Symptoms of Schizophrenia and Physical Exercise
A study testing Resistance Training and Concurrent Training in people with Schizophrenia, run by Federal University of São Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Resistance Training and Concurrent Training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2010to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- diagnosis of paranoid schizophrenia according to DSM-IV
- sedentary lifestyle for more than one year
Who cannot join
- type 1 or type 2 diabetes mellitus
- cardiovascular disease
- obesity
- Motor or neurological diseases
- drug and alcohol abuse
Trial locations and contacts
1 site in 1 country.
Brazil1 site
CEPE- Centro de Estudo em Psicobiologia e exercício
São Paulo, São Paulo, 04020-060
About this study
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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Resistance Training, Concurrent Training, Control
- Keywords
- Physical exercise, Schizophrenia, symptoms, IGF-1
- Medical subject headings
- Schizophrenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance TrainingOther
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.
Concurrent TrainingOther
The patients in this group will given a progressive concurrent training program, composed of aerobic and resistance training in the same session, twice per week (Tuesday and Thursday) for 20 weeks. Training sessions will performed at the same time of day (between 1 pm and 5 pm). the aerobic training will be conducted in Lifefitness 9700HR treadmill and the chosen exercises for resistance training 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®.
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.
ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Resistance training | Experimental | Not described Receives: Other: Resistance Training |
| Concurrent training | Experimental | Not described Receives: Other: Concurrent Training |
| Control Group | Sham comparator | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and up to 20 weeks
Secondary outcomes (2)
Calgary Depression Ratio Scale
The CDSS is a semi-structured scale composed of 9 items, all of which are defined on a scale from 0 to 3. The scale covers the two previous weeks and should be applied in an interview given by examiners who have experience with schizophrenic patients.
Measured: baseline and up to 20 weeks
Serum IGF-1
Three pre-prandial venous blood samples are taken in the morning (between 8 am and 8:30 am) from the forearm of every volunteer after a 10-hour overnight fast. IGF-1 was measured in the serum by ELISA using the E-20 DSL® Gênese® commercial kit.
Measured: baseline and up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2012 (estimated)
- Study startFeb 2010
- Primary completionDec 2010
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Tulio de Mello, Federal University of São Paulo
- Investigators
- Marco Tulio de Mello, PHD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01674543
- Sponsor's protocol ID
- ESQ-002
- Status last verified
- Aug 2014
- First submitted
- 22 Aug 2012
- Last updated
- 12 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26375919
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Schizophrenia and Physical Exercise: Effect of 20 Weeks of Training in Symptoms and Concentration in Serum IGF-1 and BDNF
- ClinicalTrials.gov ID
- NCT01674543
- Acronym / sponsor ID
- ESQ-002
- Conditions
- Schizophrenia
- Keywords
- Physical exercise, Schizophrenia, symptoms, IGF-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 29 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Resistance training | Experimental | Other: Resistance Training |
| Concurrent training | Experimental | Other: Concurrent Training |
| Control Group | Sham comparator | Other: Control |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- diagnosis of paranoid schizophrenia according to DSM-IV
- sedentary lifestyle for more than one year
Key exclusion criteria (5 listed)
- type 1 or type 2 diabetes mellitus
- cardiovascular disease
- obesity
- Motor or neurological diseases
- drug and alcohol abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance TrainingThe 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. | Other | Resistance training |
| Concurrent TrainingThe patients in this group will given a progressive concurrent training program, composed of aerobic and resistance training in the same session, twice per week (Tuesday and Thursday) for 20 weeks. Training sessions will performed at the same time of day (between 1 pm and 5 pm). the aerobic training will be conducted in Lifefitness 9700HR treadmill and the chosen exercises for resistance training 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®. 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. | Other | Concurrent training |
| ControlPatients 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. | Other | Control Group |
Primary outcome
The Positive and Negative Syndrome Scale (PANSS)
Time frame: baseline and up to 20 weeks
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.
2 secondary outcomes
Calgary Depression Ratio Scale
Time frame: baseline and up to 20 weeks
Serum IGF-1
Time frame: baseline and up to 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2014.
- Derived from this study: PubMed 26375919Silva 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Tulio de Mello, PHD principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Training and Concurrent Training in people with Schizophrenia, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Positive and Negative Syndrome Scale (PANSS) (time frame: baseline and up to 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01674543, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2014.