SchizophreniaNCT03714698
Effects of Pilates Exercise Program in Patients With Schizophrenia
A study testing Pilates exercise group in people with Schizophrenia, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Schizophrenia is one of the most frequent psychiatric disorders with a prevalence of 0.5-1.0 % all over the world. It remains one of the major reasons for disability although medical and psychosocial interventions. Read more about this study
- Who is it for?
- Ages 35 to 40 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Pilates exercise group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Oct 2016to 15 Jul 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 35 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Inclusion criteria were having symptoms of schizophrenia for at least six months, not to change the type of antipsychotic medication prescribed for at least six weeks prior to study (although dosage might change).
Who cannot join
- Patients with a severe physical disability or a physical condition that makes their participation impossible or potentially harmful (such as serious musculoskeletal or neurological disabilities) were excluded from the study. Additionally, patients who did not attend at least 10 of the 12 training sessions in the study group were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Zonguldak Bülent Ecevit University
Zonguldak, 67600
About this study
Official title: Effects of Pilates-based Exercises on Functional Capacity and Mental Health in Patients With Schizophrenia
Schizophrenia is one of the most frequent psychiatric disorders with a prevalence of 0.5-1.0 % all over the world. It remains one of the major reasons for disability although medical and psychosocial interventions.
People suffering from schizophrenia may also have many complex health troubles such as cardiovascular disease, metabolic disease, diabetes mellitus, and pulmonary problems.
Read more
Researchers have been debating the utility of exercise over depression, anxiety, and obsessive-compulsive symptoms last decades. Studies indicate that physical activity improves mood, self-esteem, energy, motivation, concentration, cognitive skills, quality of life, and social interactions. Particularly in the last decade studies have been carried out showing that various exercise approaches and physical activities contribute positively to the physical and mental health of schizophrenic patients. Clinic impacts of these interventions, dominantly including aerobic exercise, strengthening and fitness training, also varied according to the type, duration and intensity of the method used.
The knowledge obtained about schizophrenia patients point out that physically and mentally holistic approaches should be required to this complicated disease. Previous trials demonstrated that various physical activity or exercise methods have positive effects in patients with schizophrenia. However, to the best of the our knowledge, literature lacks investigation about benefits of Pilates on several domains, in particular about the potential changes on physical and mental health in patients with schizophrenia. The aim of this study was to investigate the effects of Pilates-based exercise training on the physical and mental health of schizophrenia patients.
Read the detailed description
Pilates exercises developed by Joseph Pilates has an increasing popularity in last decades. Pilates supposed that the balance between body and mind is an important factor in achieving health and happiness. Pilates stimulates the mind and decreases mental strain. The basic principles of Pilates-based approach are concentration, control, centering, diaphragmatic breathing, lightness, precision, and relaxation. It also aims to enlighten the awareness of body by inducing mind control. The control of large group muscles with coordination and focusing on breathing may increase aerobic capacity, and further improves mental health. Heretofore, some researchers also reported that the holistic approach of Pilates-based training may provide physical and psychological improvements on human health, and various intensities benefit the quality of life, mental health, physical fitness levels, and body types. Pilates exercises are utilized with a wide range spectrum for many diseases' management and are particularly used also for mental health disease such as depression, anxiety, mood etc. The sample of the study consisted of patients who were diagnosed with schizophrenia according to The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). Current study was conducted in accordance with the Helsinki Declaration and its subsequent amendments. All the subjects volunteered to participate in this research and signed the informed consent form approved by the Institutional Clinical Research Ethics Committee (Protocol no: 2015-84-21/10). On receipt of a completed consent form, patients were assigned to Pilates exercise group (PEG) or control group (CG) based on their willingness.
- Conditions
- Schizophrenia
- Being tested
- Pilates exercise group, Control Group
- Keywords
- Pilates exercise
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates exercise groupOther
Also called non-specific, activity, program
Pilates exercise group participated in supervised Pilates-based group training twice per week for six weeks
Control GroupOther
The control group participated in a routine non-specific activity program twice a week in Community Mental Health Center during study
| Study group | Role | What they receive |
|---|---|---|
| Pilates Exercise Group | Active comparator | Pilates exercise group participated in supervised Pilates-based group training twice per week for six weeks Receives: Other: Pilates exercise group |
| Control Group | Placebo comparator | the control group participated in a routine non-specific activity program twice a week in Community Mental Health Center during study Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline "6 Minute Walk Test" at 6 week
The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. Walking is an activity performed daily by all but the most severely impaired patients. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. The self-paced 6MWT assesses the submaximal level of functional capacity. Most patients do not achieve maximal exercise capacity during the 6MWT; instead, they choose their own intensity of exercise and are allowed to stop and rest during the test.
Measured: at the baseline and after six weeks
Secondary outcomes (4)
Change from baseline Calgary Depression Scale for Schizophrenia at 6 week
The Calgary Depression Scale for Schizophrenia (CDSS) was developed to assess the level of depression in schizophrenia. It is the only depression scale designed for the assessment of depression in schizophrenia and it differentiates between depression and the negative and positive symptoms of schizophrenia. The CDSS depression score is obtained by adding each of the item scores (9 items). A score above 6 has an 82% specificity and 85% sensitivity for predicting the presence of a major depressive episode.All ratings of the items are defined according to operational criteria from 0-3.
Measured: at the baseline and after six weeks
Change from baseline The Scale for the Assessment of Negative Symptoms at 6 week
The Scale for the Assessment of Negative Symptoms (SANS) was the first instrument developed in order to provide for comprehensive assessment of negative symptoms in schizophrenia (Andreasen, 1982, 1983). It consists of five scales that evaluate five different aspects of negative symptoms: alogia, affective blunting, avolition-apathy, anhedonia-asociality, and attentional impairment. Each of these negative symptoms can be rated globally, but in addition detailed observations are made in order to achieve the global rating.Each of the measures is defined and broken down in observable behavioral components that are rated on a 6-point scale. The rating of each of the behavioral components is followed by an item that describes the patient's subjective evaluation of the symptom as a whole.
Measured: at the baseline and after six weeks
Change from baseline The Scale for the Assessment of Positive Symptoms (SAPS) at 6 week
The Assessment of Positive Symptoms (SAPS) permits detailed evaluation and global ratings of hallucinations, delusions, positive formal thought disorder and bizarre behaviour (Andreasen, 1984). Taken together, the two scales provide a comprehensive set of rating scales in order to measure the symptoms of schizophrenia and to assess their change over time.The scale was developed by Nancy Andreasen and was first published in 1984. SAPS is split into 4 domains, and within each domain separate symptoms are rated from 0 (absent) to 5 (severe). The scale is closely linked to the Scale for the Assessment of Negative Symptoms (SANS) which was published a few years earlier.
Measured: at the baseline and after six weeks
Change from baseline The Brief Psychiatric Rating Scale at 6 week
The Brief Psychiatric Rating Scale (BPRS) is a rating scale which a clinician or researcher may use to measure psychiatric symptoms such as depression, anxiety, hallucinations and unusual behaviour. Each symptom is rated 1-7 and depending on the version between a total of 18-24 symptoms are scored. The scale is one of the oldest, most widely used scales to measure psychotic symptoms and was first published in 1962.The single items were rated on a seven-point scale (1, not present; 2, very mild; 3, mild; 4, moderate; 5, moderately severe; 6, severe; 7, extremely severe). Thus, the range of possible BPRS total scores is from 18 to 126.
Measured: at the baseline and after six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start12 Oct 2016
- Primary completion15 Jul 2018
- Study completion15 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Pilates exercise group participated in supervised Pilates-based group training twice per week for six weeks, while the control group participated in a routine non-specific activity program twice a week in Community Mental Health Center during study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gizem Irem KINIKLI, Hacettepe University
- Investigators
- Eda AKBAŞ, Assist.Prof., Principal investigator, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714698
- Sponsor's protocol ID
- 2015-84-21/10
- Status last verified
- Oct 2018
- First submitted
- 19 Oct 2018
- Last updated
- 24 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Beebe LH, Tian L, Morris N, Goodwin A, Allen SS, Kuldau J. Effects of exercise on mental and physical health parameters of persons with schizophrenia. Issues Ment Health Nurs. 2005 Jul;26(6):661-76. doi: 10.1080/01612840590959551.
PubMed 16020076Rimes RR, de Souza Moura AM, Lamego MK, de Sa Filho AS, Manochio J, Paes F, Carta MG, Mura G, Wegner M, Budde H, Ferreira Rocha NB, Rocha J, Tavares JM, Arias-Carrion O, Nardi AE, Yuan TF, Machado S. Effects of Exercise on Physical and Mental Health, and Cognitive and Brain Functions in Schizophrenia: Clinical and Experimental Evidence. CNS Neurol Disord Drug Targets. 2015;14(10):1244-54. doi: 10.2174/1871527315666151111130659.
PubMed 26556069Oertel-Knochel V, Mehler P, Thiel C, Steinbrecher K, Malchow B, Tesky V, Ademmer K, Prvulovic D, Banzer W, Zopf Y, Schmitt A, Hansel F. Effects of aerobic exercise on cognitive performance and individual psychopathology in depressive and schizophrenia patients. Eur Arch Psychiatry Clin Neurosci. 2014 Oct;264(7):589-604. doi: 10.1007/s00406-014-0485-9. Epub 2014 Feb 2.
PubMed 24487666Firth J, Cotter J, Elliott R, French P, Yung AR. A systematic review and meta-analysis of exercise interventions in schizophrenia patients. Psychol Med. 2015 May;45(7):1343-61. doi: 10.1017/S0033291714003110. Epub 2015 Feb 4.
PubMed 25650668
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pilates-based Exercises on Functional Capacity and Mental Health in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT03714698
- Acronym / sponsor ID
- 2015-84-21/10
- Conditions
- Schizophrenia
- Keywords
- Pilates exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 12 Oct 2016 (actual)
- Primary completion
- 15 Jul 2018 (actual)
- Study completion
- 15 Jul 2018 (actual)
- First posted
- 22 Oct 2018 (actual)
- 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.
Schizophrenia is one of the most frequent psychiatric disorders with a prevalence of 0.5-1.0 % all over the world. It remains one of the major reasons for disability although medical and psychosocial interventions.
People suffering from schizophrenia may also have many complex health troubles such as cardiovascular disease, metabolic disease, diabetes mellitus, and pulmonary problems.
Researchers have been debating the utility of exercise over depression, anxiety, and obsessive-compulsive symptoms last decades. Studies indicate that physical activity improves mood, self-esteem, energy, motivation, concentration, cognitive skills, quality of life, and social interactions. Particularly in the last decade studies have been carried out showing that various exercise approaches and physical activities contribute positively to the physical and mental health of schizophrenic patients. Clinic impacts of these interventions, dominantly including aerobic exercise, strengthening and fitness training, also varied according to the type, duration and intensity of the method used.
The knowledge obtained about schizophrenia patients point out that physically and mentally holistic approaches should be required to this complicated disease. Previous trials demonstrated that various physical activity or exercise methods have positive effects in patients with schizophrenia. However, to the best of the our knowledge, literature lacks investigation about benefits of Pilates on several domains, in particular about the potential changes on physical and mental health in patients with schizophrenia. The aim of this study was to investigate the effects of Pilates-based exercise training on the physical and mental health of schizophrenia patients.
Detailed description
Pilates exercises developed by Joseph Pilates has an increasing popularity in last decades. Pilates supposed that the balance between body and mind is an important factor in achieving health and happiness. Pilates stimulates the mind and decreases mental strain. The basic principles of Pilates-based approach are concentration, control, centering, diaphragmatic breathing, lightness, precision, and relaxation. It also aims to enlighten the awareness of body by inducing mind control. The control of large group muscles with coordination and focusing on breathing may increase aerobic capacity, and further improves mental health. Heretofore, some researchers also reported that the holistic approach of Pilates-based training may provide physical and psychological improvements on human health, and various intensities benefit the quality of life, mental health, physical fitness levels, and body types. Pilates exercises are utilized with a wide range spectrum for many diseases' management and are particularly used also for mental health disease such as depression, anxiety, mood etc. The sample of the study consisted of patients who were diagnosed with schizophrenia according to The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). Current study was conducted in accordance with the Helsinki Declaration and its subsequent amendments. All the subjects volunteered to participate in this research and signed the informed consent form approved by the Institutional Clinical Research Ethics Committee (Protocol no: 2015-84-21/10). On receipt of a completed consent form, patients were assigned to Pilates exercise group (PEG) or control group (CG) based on their willingness.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Pilates exercise group participated in supervised Pilates-based group training twice per week for six weeks, while the control group participated in a routine non-specific activity program twice a week in Community Mental Health Center during study
| Arm | Type | Receives |
|---|---|---|
| Pilates Exercise Group | Active comparator | Other: Pilates exercise groupPilates exercise group participated in supervised Pilates-based group training twice per week for six weeks |
| Control Group | Placebo comparator | Other: Control Groupthe control group participated in a routine non-specific activity program twice a week in Community Mental Health Center during study |
Who may qualify
- Ages
- 35 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Inclusion criteria were having symptoms of schizophrenia for at least six months, not to change the type of antipsychotic medication prescribed for at least six weeks prior to study (although dosage might change).
Key exclusion criteria (1 listed)
- Patients with a severe physical disability or a physical condition that makes their participation impossible or potentially harmful (such as serious musculoskeletal or neurological disabilities) were excluded from the study. Additionally, patients who did not attend at least 10 of the 12 training sessions in the study group were excluded from the study.
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 |
|---|---|---|
| Pilates exercise groupAlso: non-specific, activity, programPilates exercise group participated in supervised Pilates-based group training twice per week for six weeks | Other | Pilates Exercise Group |
| Control GroupThe control group participated in a routine non-specific activity program twice a week in Community Mental Health Center during study | Other | Control Group |
Primary outcome
Change from baseline "6 Minute Walk Test" at 6 week
Time frame: at the baseline and after six weeks
The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. Walking is an activity performed daily by all but the most severely impaired patients. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. The self-paced 6MWT assesses the submaximal level of functional capacity. Most patients do not achieve maximal exercise capacity during the 6MWT; instead, they choose their own intensity of exercise and are allowed to stop and rest during the test.
4 secondary outcomes
Change from baseline Calgary Depression Scale for Schizophrenia at 6 week
Time frame: at the baseline and after six weeks
Change from baseline The Scale for the Assessment of Negative Symptoms at 6 week
Time frame: at the baseline and after six weeks
Change from baseline The Scale for the Assessment of Positive Symptoms (SAPS) at 6 week
Time frame: at the baseline and after six weeks
Change from baseline The Brief Psychiatric Rating Scale at 6 week
Time frame: at the baseline and after six weeks
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 24 Oct 2018.
- Background: PubMed 16020076Beebe LH, Tian L, Morris N, Goodwin A, Allen SS, Kuldau J. Effects of exercise on mental and physical health parameters of persons with schizophrenia. Issues Ment Health Nurs. 2005 Jul;26(6):661-76. doi: 10.1080/01612840590959551.
- Background: PubMed 26556069Rimes RR, de Souza Moura AM, Lamego MK, de Sa Filho AS, Manochio J, Paes F, Carta MG, Mura G, Wegner M, Budde H, Ferreira Rocha NB, Rocha J, Tavares JM, Arias-Carrion O, Nardi AE, Yuan TF, Machado S. Effects of Exercise on Physical and Mental Health, and Cognitive and Brain Functions in Schizophrenia: Clinical and Experimental Evidence. CNS Neurol Disord Drug Targets. 2015;14(10):1244-54. doi: 10.2174/1871527315666151111130659.
- Background: PubMed 24487666Oertel-Knochel V, Mehler P, Thiel C, Steinbrecher K, Malchow B, Tesky V, Ademmer K, Prvulovic D, Banzer W, Zopf Y, Schmitt A, Hansel F. Effects of aerobic exercise on cognitive performance and individual psychopathology in depressive and schizophrenia patients. Eur Arch Psychiatry Clin Neurosci. 2014 Oct;264(7):589-604. doi: 10.1007/s00406-014-0485-9. Epub 2014 Feb 2.
- Background: PubMed 25650668Firth J, Cotter J, Elliott R, French P, Yung AR. A systematic review and meta-analysis of exercise interventions in schizophrenia patients. Psychol Med. 2015 May;45(7):1343-61. doi: 10.1017/S0033291714003110. Epub 2015 Feb 4.
- Individual participant dataSharing planned: Undecided
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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.
Eda AKBAŞ, Assist.Prof. principal investigator
Zonguldak Bulent Ecevit University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates exercise group in people with Schizophrenia, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 24 Oct 2018. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
Change from baseline "6 Minute Walk Test" at 6 week (time frame: at the baseline and after six weeks). 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 NCT03714698, which also lists 4 linked publications.
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 24 Oct 2018.