Multimodal Physical Therapy Program in Schizophrenia

Schizophrenia Clinical Trial

Official title:

Effectiveness of a Multimodal Physical Therapy Program on Clinical Symptomatology and Physical Fitness in Persons With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02413164
• Other study ID #: 12-2014
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: May 1, 2018

Study information

• Verified date: January 2019
• Source: University of Malaga
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 1, 2018
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Persons with diagnosis of schizophrenia

• Have agreed to agreeing to participate in the study

• Have signed the informed consent

• Be able to complete scales and perform physical tests

Exclusion Criteria:

• Have a contraindication for performing physical intervention.

• Destabilization of the symptoms

• Be participating in a program of structured physical activity

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Other:
• A multimodal physiotherapy programme
Intervention: individualised Multimodal Physiotherapy Programme of therapeutic exercises with education healthy-style-of-life based. Groupal sessions two times per week during 12 weeks. Each session 60 minutes: 10 minutes of warm up, 20 minutes of strength and muscular endurance, 20 minuts of aerobic training, 10 minutes of cold-down. Intensity aerobic training: The training heart rate will be calculated according to recommendations of the American College of Sport Medicine (ACSM), it must oscillate between 55/65% and 90% of the HRmax. Initial four weeks: moderate intensity (55-69% HRmax); Following weeks according to each response, to higher level of training (70-89% HRmax). Strength training: individualised working with the principal muscular groups. 3 sessions using a weight which can repeat the exercise 10-15 times, increasing to a weight at which they can repeat the exercise 8-12 times.

Locations

Country	Name	City	State
Spain	IBIMA	Malaga	Málaga

Sponsors (2)

Lead Sponsor	Collaborator
University of Malaga	Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive and Negative Syndrome Scale (PANSS)	The Positive and Negative Syndrome Scale--Spanish adaptation. Peralta V. Psychometric properties of the positive and negative syndrome scale (PANSS) in schizophrenia.; The spanish version of this scale has a (CCI=0.71 for possitive symptoms; CCI=0.80 for negative symptoms; CCI=0.56 In General psycopatology).	Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)
Secondary	International Physical activity Questionnaire. Short form (IPAQ-7)	The short version will be used centred on the time and intensity of the physical activity undertaken by the subject in the last 7 days.	Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)
Secondary	Physical activity (accelerometry)	For measure the physical activity level of participants an accelerometer will be use during 9 days (dismissing the first and the last days for analysis data)	Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)
Secondary	Self-efficacy and social support for physical activity (SS/SE)	Adaptation and psychometric properties of the self-efficacy/social support for activity for persons with intellectual disability scale (SE/SS-AID) in a Spanish sample.	Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)
Secondary	12-Item Short-Form Health Survey	Reliability and validity of the SF-12 health survey among people with severe mental illness.	Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)
Secondary	Internalized Stigma of Mental Health questionnaire	Internalized stigma of mental illness: psychometric properties of a new measure.; Proposal of a socio-cognitive-behavioral structural equation model of internalized stigma in people with severe	Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)
Secondary	Self-determination motivation in physical fitness	self-determination motivation in a physical fitness setting: validation of the Behavioural Regulation in Exercise Questionnaire-2 (BREQ-2) in a Spanish sample.	Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)
Secondary	Client Service Receipt Inventory (CSRI).	The cost effectiveness will be measured by evaluating the services used by the subjects using the Spanish version of the Client Service Receipt Inventory (CSRI).; Client Socio-Demographic and Service Receipt Inventory-European Version: development of an instrument for international research. EPSILON Study 5. European Psychiatric Services: inputs Linked to Outcome Domains and Needs. Br J Psychiatry, Suppl. 2000;39:28-63 Vázquez-Barquero J, Gaite L, Cuesta M, García-Usieto E, Knapp M, Beecham J. Versión española del CSRI: una entrevista para la evaluación de costes en salud mental. Arch Neurobiol (Madr). 1997;60(2):171-84.; This is a structured interview with either the subjector their carers, to obtain retrospective information about the use of health and social services in the past 12 months.	Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)
Secondary	Physical fitness (6-min walk test, Timed up and go test, 30 seconds sit to stand test, handgrip test)	The 6 minute test. A test of cardiorespiratory function which consists in measuring the maximum distance the subject can cover in 6 six minutes using a standard procedure.; Timed up and go test. This is a test to evaluate mobility that requires both static and dynamic equilibrium. It measures the time that the subject takes to stand up from sitting, walk three metres, turn around and return to sit down in the seat.; 30 seconds sit to stand test(49,50). Measures the number of times that the subject can sit down in and stand up from a chair without using the support of the arms (arms will remain crossed across the chest during the test). This measures the strength of the legs.; Handgrip test: This test is carried out using the recommendations of the American Association of Manual Therapies using a Jamar dynamometer.	Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)