SchizophreniaNCT02413164
Multimodal Physical Therapy Program in Schizophrenia
A study testing A multimodal physiotherapy programme in people with Schizophrenia, run by University of Malaga at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- A multimodal physiotherapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2017to 1 May 2018
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Have a contraindication for performing physical intervention.
- Destabilization of the symptoms
- Be participating in a program of structured physical activity
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- A multimodal physiotherapy programme
- Keywords
- Schizophrenia, Mental Health, Physical Therapy, Quality of life, Stigma, Positive and negative symptoms, Physical fitness, Physical activity
- Medical subject headings
- Schizophrenia, Psychological Well-Being, Social Stigma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A multimodal physiotherapy programmeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Physical intervention group | Experimental | 12 weeks of groupal sessions of individualised multimodal physiotherapy programme of therapeutic exercises with education healthy-style-of-life based, 2 times for week. Receives: Other: A multimodal physiotherapy programme |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)
Secondary outcomes (8)
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.
Measured: Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)
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)
Measured: Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)
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.
Measured: Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)
12-Item Short-Form Health Survey
Reliability and validity of the SF-12 health survey among people with severe mental illness.
Measured: Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)
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
Measured: Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)
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.
Measured: Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)
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.
Measured: Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)
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.
Measured: Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study start1 Mar 2017
- Primary completion1 Jun 2017
- Study completion1 May 2018
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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Responsible party
- Principal investigator, Dr. Antonio I Cuesta-Vargas, University of Malaga
- Investigators
- Antonio I Cuesta Vargas, PhD, Principal investigator, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02413164
- Sponsor's protocol ID
- 12-2014
- Status last verified
- Jan 2019
- First submitted
- 24 Mar 2015
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29720196
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Multimodal Physical Therapy Program on Clinical Symptomatology and Physical Fitness in Persons With Schizophrenia
- ClinicalTrials.gov ID
- NCT02413164
- Acronym / sponsor ID
- 12-2014
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Mental Health, Physical Therapy, Quality of life, Stigma, Positive and negative symptoms, Physical fitness, Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Collaborators
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 9 Apr 2015 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical intervention group | Experimental | Other: A multimodal physiotherapy programme12 weeks of groupal sessions of individualised multimodal physiotherapy programme of therapeutic exercises with education healthy-style-of-life based, 2 times for week. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Have a contraindication for performing physical intervention.
- Destabilization of the symptoms
- Be participating in a program of structured physical activity
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 |
|---|---|---|
| A multimodal physiotherapy programmeIntervention: 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. | Other | Physical intervention group |
Primary outcome
Positive and Negative Syndrome Scale (PANSS)
Time frame: Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)
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).
8 secondary outcomes
International Physical activity Questionnaire. Short form (IPAQ-7)
Time frame: Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)
Physical activity (accelerometry)
Time frame: Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)
Self-efficacy and social support for physical activity (SS/SE)
Time frame: Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)
12-Item Short-Form Health Survey
Time frame: Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)
Internalized Stigma of Mental Health questionnaire
Time frame: Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)
Self-determination motivation in physical fitness
Time frame: Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)
Client Service Receipt Inventory (CSRI).
Time frame: Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)
Physical fitness (6-min walk test, Timed up and go test, 30 seconds sit to stand test, handgrip test)
Time frame: Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)
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 27 Sep 2019.
- Derived from this study: PubMed 29720196Perez-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.
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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.
Antonio I Cuesta Vargas, PhD principal investigator
University of Malaga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A multimodal physiotherapy programme in people with Schizophrenia, run by University of Malaga at 1 site in Spain.
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 4 inclusion and 3 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 27 Sep 2019. 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 Spain. 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. 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?
Positive and Negative Syndrome Scale (PANSS) (time frame: Baseline, 4 moth (Postintervention) and 13 month from baseline (9 months postintervention)). 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 NCT02413164, 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 27 Sep 2019.