Clinical trial NCT02413164: Multimodal Physical Therapy Program in Schizophrenia
Official title: Effectiveness of a Multimodal Physical Therapy Program on Clinical Symptomatology and Physical Fitness in Persons With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Schizophrenia
Mental Health
Physical Therapy
Quality of life
Stigma
Positive and negative symptoms
Physical fitness
Physical activity
Lead sponsor: University of Malaga
Sponsor class: OTHER
Collaborators: name: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
First posted: 2015-04-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)
Secondary outcomes:
measure: International Physical activity Questionnaire. Short form (IPAQ-7)
timeFrame: Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)
measure: Physical activity (accelerometry)
timeFrame: Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)
measure: Self-efficacy and social support for physical activity (SS/SE)
timeFrame: Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)
measure: 12-Item Short-Form Health Survey
timeFrame: Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)
measure: Internalized Stigma of Mental Health questionnaire
timeFrame: Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)
measure: Self-determination motivation in physical fitness
timeFrame: Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)
measure: Client Service Receipt Inventory (CSRI).
timeFrame: Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)
measure: Physical fitness (6-min walk test, Timed up and go test, 30 seconds sit to stand test, handgrip test)
timeFrame: Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)
Other outcomes:
Locations:
city: Malaga
country: Spain
facility: IBIMA
state: Málaga
Study officials:
affiliation: University of Malaga
name: Antonio I Cuesta Vargas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Perez-Cruzado D, Cuesta-Vargas AI, Vera-Garcia E, Mayoral-Cleries F. The relationship between quality of life and physical fitness in people with severe mental illness. Health Qual Life Outcomes. 2018 May 2;16(1):82. doi: 10.1186/s12955-018-0909-8.