Schizophrenia Clinical Trial
Official title:
Effectiveness of a Multimodal Physical Therapy Program on Clinical Symptomatology and Physical Fitness in Persons With Schizophrenia
The aim of the investigators' study would evaluate the effectiveness of a multimodal exercise
program on physical fitness, physical activity level and clinical symptomatology in patients
with schizophrenia.
DESIGN: Randomized controlled trial. SUBJECTS OF THE STUDY: People with schizophrenia who
receiving treatment in Regional Hospital of Malaga. INTERVENTION: DATA ANALYSIS: descriptive
statistics, measuring central tendency and dispersion of the variables study. Inferential
statistics will be made between intervention of key variables and outcome.
It´s well known that life expectancy of people with severe mental disorders is approximately
from 15 to 20 years less compared with general population. The higher mortality risk in this
population group reflects a combination of factors: a) increased prevalence of comorbid
medical conditions; b) adverse effects of pharmacological treatment; c) higher rates of
suicide, accidental and other violent death; d) poorer access to physical healthcare than for
the general population. In addition, this vulnerable population has an extremely high
prevalence of obesity, nearly twice that of the overall population. Therefore, it is not
surprising that persons with serious mental illness have an increased occurrence of
weight-related conditions, including heightened risk of diabetes mellitus, hypertension, and
dyslipidaemia; in addiction to this, these pathologies are under-diagnosed and under-treated.
Environmental issues and unhealthy lifestyle can account for all these conditions,
particularly in people with SMI, such as high levels of cigarette smoking, unhealthy diet or
sedentary life style. Tendency to isolation and a reduced social network are often obstacles
to the practice of physical exercise.
In addition, antipsychotics, in particular atypical antipsychotics, have been associated with
weight gain, dyslipidaemia, diabetes, and other cardiac risk factors. Furthermore, the side
effects of these medications are one of the most significant barriers to changing their
lifestyle.
Finally, the stigma associated with mental illness may also contribute to low levels of
participation in mainstream leisure-time physical activities.
Regular practise of physical exercise improves physical and mental health in the general
population. A recent systematic review of physical activity and schizophrenia has shown
improvement in both positive and negative symptoms, and a general increase in wellbeing of
people with schizophrenia. In addition to cardiac and metabolic effects, physical exercise
has demonstrated an improvement in both depression and anxiety.
The main objective of this study is to evaluate the effectiveness of a multimodal physical
activity programme in physical fitness and physical activity level in persons with a
diagnosis of schizophrenia.
Secondary objectives are: Evaluate the effect of this intervention in clinical
symptomatology; Analyse the effect of this programme in motivating these persons to undertake
physical activity; Identify the effect of the program on the physical fitness of the
subjects; Evaluate any influence of the program on the self-perception of stigma in the
subjects; Evaluate any variation of level of physical activity before and after the study in
the subjects; Measure the impact on the quality of life of people who participate in this
study; Perform a cost-effectiveness analysis of the program.
The present study is a randomized clinical trial to compare the effect of a multimodal,
individualized, physical programme of muscular strength, endurance, aerobic training and
health education against a control group.
All variables will be measured at the beginning and the end of the 12-week program by the
same evaluator, whose group of subjects will be randomly allocated to the trial group and
control group without their knowledge. Furthermore, the variables will be measured 9 months
after the end of the program. Subjects allocated to the control group will have all the same
variables measured, and will be given the option to participate in the program once the study
is completed.
;
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 |
NCT03209778 -
Involuntary Memories Investigation in Schizophrenia
|
N/A | |
Terminated |
NCT03261817 -
A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders
|
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 |