Multimodal Physical Therapy Program in Schizophrenia

NCT ID: NCT02413164

Last Updated: 2019-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2018-05-01

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Physical intervention group

12 weeks of groupal sessions of individualised multimodal physiotherapy programme of therapeutic exercises with education healthy-style-of-life based, 2 times for week.

Group Type: EXPERIMENTAL

A multimodal physiotherapy programme

Intervention Type: OTHER

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.

Control group

This group will receive usual care and will be in wait list status for the duration of study, later the intervention will be offered to this group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

OTHER

Sponsor Role: collaborator

University of Malaga

OTHER

Sponsor Role: lead

Responsible Party

Dr. Antonio I Cuesta-Vargas

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonio I Cuesta Vargas, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Malaga

Locations

IBIMA

Málaga, Málaga, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 29720196 (View on PubMed)

Other Identifiers

12-2014

Identifier Type: -

Identifier Source: org_study_id