Stroke, IschemicNCT03195907
Pulmonary Physiotherapy for Ischemic Stroke
An observational study of Stroke, Ischemic and Intensive Care Neurological Disorder, run by Abdulkadir Tunc at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates the predictors of intensive care unit admission and mortality among stroke patients and the effects of pulmonary physiotherapy on these stroke patients. One-hundred patients participated in the pulmonary rehabilitation program and 81 patients served as a control group. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Stroke, Ischemic, Intensive Care Neurological Disorder, Morality
- What is being tested?
- Pulmonary physiotherapy
- How many people
- 181 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2015to 1 Jan 2016
- Phase
- Observational
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were admitted to the neurology clinic stroke unit or the neurological intensive care unit
Who may be able to join
- acute ischemic stroke confirmed by computed tomography or a diffusion-weighed magnetic resonance imaging scan,
- aged > 40 years,
- ability to understand and follow simple verbal instructions,
- modified Rankin scale score > 2,
- National Institute of Health Stroke Scale score > 0,
- no unrestricted movement of the lips,
- no receptive aphasia and no history of thoracic or abdominal surgery.
Who cannot join
- blood pressure >180/100 mm Hg more than twice in 24 h;
- significant pulmonary disease, angina, myocardial infarction or acute heart failure within three months;
- neurological conditions other than stroke;
- presence of a severe visual disability and visual field defects;
- receiving medications that would influence the metabolic or cardiorespiratory responses to exercise;
- inability to perform the tests.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictors of Intensive Care Unit Admission and Mortality in Patients With Ischemic Stroke: Investigating the Effects of a Pulmonary Rehabilitation Program
This study evaluates the predictors of intensive care unit admission and mortality among stroke patients and the effects of pulmonary physiotherapy on these stroke patients. One-hundred patients participated in the pulmonary rehabilitation program and 81 patients served as a control group.
Read the detailed description
Predicting early mortality and disability after a stroke depends on many factors, such as age, the type of stroke, lesional location, level of consciousness, severity of neurological impairment, medical risk factors (hypertension and diabetes), premorbid conditions, fever and history of stroke. Stroke patients may experience a reduction of up to 50% in respiratory function when compared to age- and gender-matched norms. The reduction in respiratory function can lead to decreased endurance, dyspnoea and increased sedentary behaviour, as well as an elevated risk of stroke. The reduction in respiratory function may also cause aspiration, leading to pneumonia.
The aim of pulmonary rehabilitation program is to enhance respiratory muscle resistance during breathing, thereby improving respiratory function. Pulmonary rehabilitation programs are considered to be capable of inducing positive effects on stroke patients' respiratory muscles through diaphragm breathing exercise and lip puckering breathing exercise. Pulmonary physiotherapy (PPT) improves the quality of life of stroke patients.
The PPT program was conducted by physical therapists at our hospital for 30 min, three days/week. As part of the PPT, a physiotherapist monitored this group for 12 weeks. The same physiotherapist supervised all the exercises. During the exercise program, all patients were clinically stable and all were receiving optimal medical therapy. Rehabilitation started with inspiratory diaphragm breathing exercises. The physiotherapist placed his hands on the superior rectus abdominis immediately below the anterior costal cartilage and induced inspiratory diaphragm breathing by instructing the patient to slowly and deeply inhale the air through the nose. Then the patient was instructed to perform expiratory pursed-lip breathing exercise by continuously exhale the air. During pursed-lip breathing exercise, the patient was instructed in sequence, to breathe in gently through the nose, purse his/ her lips as though whistling and then breathe out through the long pursed lips by not exerting power until she/ he is short of breath. The expiration time was set to be at least twice times longer than inspiration time. The patients took a rest when they complained about fatigue or dizziness during breathing exercise and conducted breathing exercise again. The exercise intensity was based on the maximal heart rate and maximal effort of the patients. Each patient's performance during the exercise sessions was recorded and reported regularly to the patient's physician. National Institute of Health Stroke Scale scores, modified Rankin scale scores, pneumonia onset, admission to the intensive care unit and mortality were recorded at the end of the first and third month.
- Being tested
- Pulmonary physiotherapy
- Keywords
- Stroke, Mortality, Intensive care unit, Pulmonary rehabilitation
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary physiotherapyOther
| Study group | Role | What they receive |
|---|---|---|
| PPT group | Those participated in pulmonary rehabilitation program Receives: Other: Pulmonary physiotherapy | |
| Control group | Those served as control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensive care unit admission
Patients who require mechanical ventilation were admitted to the neurological intensive care unit
Measured: 3 months
Secondary outcomes (4)
Mortality rates
Mortality rates after stroke
Measured: 3 months
Assessment of stroke severity
Evaluated with National Institute of Health Stroke Scale in both groups
Measured: 3 months
Assessment of functional disability
Evaluated with modified Rankin scale in both groups
Measured: 3 months
Pneumonia onset
Pulmonary onset rates
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start1 Feb 2015
- Primary completion1 Jan 2016
- Study completion1 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Stroke, IschemicStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abdulkadir Tunc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Abdulkadir Tunc, Bezmialem Vakif University
- Investigators
- Abdulkadir TUNÇ, MD, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195907
- Sponsor's protocol ID
- StrokePPT
- Status last verified
- Jun 2017
- First submitted
- 20 Jun 2017
- Last updated
- 22 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets during and/or analysed during the current study available from the corresponding author on reasonable request.
Publications
Seo K, Hwan PS, Park K. The effects of inspiratory diaphragm breathing exercise and expiratory pursed-lip breathing exercise on chronic stroke patients' respiratory muscle activation. J Phys Ther Sci. 2017 Mar;29(3):465-469. doi: 10.1589/jpts.29.465. Epub 2017 Mar 22.
PubMed 28356632Lan MY, Wu SJ, Chang YY, Chen WH, Lai SL, Liu JS. Neurologic and non-neurologic predictors of mortality in ischemic stroke patients admitted to the intensive care unit. J Formos Med Assoc. 2006 Aug;105(8):653-8. doi: 10.1016/S0929-6646(09)60164-9.
PubMed 16935766Grube MM, Koennecke HC, Walter G, Meisel A, Sobesky J, Nolte CH, Wellwood I, Heuschmann PU; Berlin Stroke Register (BSR). Influence of acute complications on outcome 3 months after ischemic stroke. PLoS One. 2013 Sep 24;8(9):e75719. doi: 10.1371/journal.pone.0075719. eCollection 2013.
PubMed 24086621Kim J, Park JH, Yim J. Effects of respiratory muscle and endurance training using an individualized training device on the pulmonary function and exercise capacity in stroke patients. Med Sci Monit. 2014 Dec 5;20:2543-9. doi: 10.12659/MSM.891112.
PubMed 25488849Katz-Leurer M, Shochina M, Carmeli E, Friedlander Y. The influence of early aerobic training on the functional capacity in patients with cerebrovascular accident at the subacute stage. Arch Phys Med Rehabil. 2003 Nov;84(11):1609-14. doi: 10.1053/s0003-9993(03)00344-7.
PubMed 14639559Gungen BD, Tunc A, Aras YG, Gundogdu AA, Gungen AC, Bal S. Predictors of intensive care unit admission and mortality in patients with ischemic stroke: investigating the effects of a pulmonary rehabilitation program. BMC Neurol. 2017 Jul 11;17(1):132. doi: 10.1186/s12883-017-0912-4.
PubMed 28693521
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Intensive Care Unit Admission and Mortality in Patients With Ischemic Stroke: Investigating the Effects of a Pulmonary Rehabilitation Program
- ClinicalTrials.gov ID
- NCT03195907
- Acronym / sponsor ID
- StrokePPT
- Keywords
- Stroke, Mortality, Intensive care unit, Pulmonary rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Abdulkadir TuncUniversity, hospital or other
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 1 Jan 2016 (actual)
- Study completion
- 1 Jan 2016 (actual)
- First posted
- 22 Jun 2017 (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.
This study evaluates the predictors of intensive care unit admission and mortality among stroke patients and the effects of pulmonary physiotherapy on these stroke patients. One-hundred patients participated in the pulmonary rehabilitation program and 81 patients served as a control group.
Detailed description
Predicting early mortality and disability after a stroke depends on many factors, such as age, the type of stroke, lesional location, level of consciousness, severity of neurological impairment, medical risk factors (hypertension and diabetes), premorbid conditions, fever and history of stroke. Stroke patients may experience a reduction of up to 50% in respiratory function when compared to age- and gender-matched norms. The reduction in respiratory function can lead to decreased endurance, dyspnoea and increased sedentary behaviour, as well as an elevated risk of stroke. The reduction in respiratory function may also cause aspiration, leading to pneumonia.
The aim of pulmonary rehabilitation program is to enhance respiratory muscle resistance during breathing, thereby improving respiratory function. Pulmonary rehabilitation programs are considered to be capable of inducing positive effects on stroke patients' respiratory muscles through diaphragm breathing exercise and lip puckering breathing exercise. Pulmonary physiotherapy (PPT) improves the quality of life of stroke patients.
The PPT program was conducted by physical therapists at our hospital for 30 min, three days/week. As part of the PPT, a physiotherapist monitored this group for 12 weeks. The same physiotherapist supervised all the exercises. During the exercise program, all patients were clinically stable and all were receiving optimal medical therapy. Rehabilitation started with inspiratory diaphragm breathing exercises. The physiotherapist placed his hands on the superior rectus abdominis immediately below the anterior costal cartilage and induced inspiratory diaphragm breathing by instructing the patient to slowly and deeply inhale the air through the nose. Then the patient was instructed to perform expiratory pursed-lip breathing exercise by continuously exhale the air. During pursed-lip breathing exercise, the patient was instructed in sequence, to breathe in gently through the nose, purse his/ her lips as though whistling and then breathe out through the long pursed lips by not exerting power until she/ he is short of breath. The expiration time was set to be at least twice times longer than inspiration time. The patients took a rest when they complained about fatigue or dizziness during breathing exercise and conducted breathing exercise again. The exercise intensity was based on the maximal heart rate and maximal effort of the patients. Each patient's performance during the exercise sessions was recorded and reported regularly to the patient's physician. National Institute of Health Stroke Scale scores, modified Rankin scale scores, pneumonia onset, admission to the intensive care unit and mortality were recorded at the end of the first and third month.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PPT group | – | Other: Pulmonary physiotherapyThose participated in pulmonary rehabilitation program |
| Control group | – | –Those served as control group |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were admitted to the neurology clinic stroke unit or the neurological intensive care unit
Key inclusion criteria (7 listed)
- acute ischemic stroke confirmed by computed tomography or a diffusion-weighed magnetic resonance imaging scan,
- aged > 40 years,
- ability to understand and follow simple verbal instructions,
- modified Rankin scale score > 2,
- National Institute of Health Stroke Scale score > 0,
Key exclusion criteria (6 listed)
- blood pressure >180/100 mm Hg more than twice in 24 h;
- significant pulmonary disease, angina, myocardial infarction or acute heart failure within three months;
- neurological conditions other than stroke;
- presence of a severe visual disability and visual field defects;
- receiving medications that would influence the metabolic or cardiorespiratory responses to exercise;
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 |
|---|---|---|
| Pulmonary physiotherapy | Other | PPT group |
Primary outcome
Intensive care unit admission
Time frame: 3 months
Patients who require mechanical ventilation were admitted to the neurological intensive care unit
4 secondary outcomes
Mortality rates
Time frame: 3 months
Assessment of stroke severity
Time frame: 3 months
Assessment of functional disability
Time frame: 3 months
Pneumonia onset
Time frame: 3 months
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 22 Jun 2017.
- Results publication: PubMed 28356632Seo K, Hwan PS, Park K. The effects of inspiratory diaphragm breathing exercise and expiratory pursed-lip breathing exercise on chronic stroke patients' respiratory muscle activation. J Phys Ther Sci. 2017 Mar;29(3):465-469. doi: 10.1589/jpts.29.465. Epub 2017 Mar 22.
- Results publication: PubMed 16935766Lan MY, Wu SJ, Chang YY, Chen WH, Lai SL, Liu JS. Neurologic and non-neurologic predictors of mortality in ischemic stroke patients admitted to the intensive care unit. J Formos Med Assoc. 2006 Aug;105(8):653-8. doi: 10.1016/S0929-6646(09)60164-9.
- Results publication: PubMed 24086621Grube MM, Koennecke HC, Walter G, Meisel A, Sobesky J, Nolte CH, Wellwood I, Heuschmann PU; Berlin Stroke Register (BSR). Influence of acute complications on outcome 3 months after ischemic stroke. PLoS One. 2013 Sep 24;8(9):e75719. doi: 10.1371/journal.pone.0075719. eCollection 2013.
- Results publication: PubMed 25488849Kim J, Park JH, Yim J. Effects of respiratory muscle and endurance training using an individualized training device on the pulmonary function and exercise capacity in stroke patients. Med Sci Monit. 2014 Dec 5;20:2543-9. doi: 10.12659/MSM.891112.
- Results publication: PubMed 14639559Katz-Leurer M, Shochina M, Carmeli E, Friedlander Y. The influence of early aerobic training on the functional capacity in patients with cerebrovascular accident at the subacute stage. Arch Phys Med Rehabil. 2003 Nov;84(11):1609-14. doi: 10.1053/s0003-9993(03)00344-7.
- Derived from this study: PubMed 28693521Gungen BD, Tunc A, Aras YG, Gundogdu AA, Gungen AC, Bal S. Predictors of intensive care unit admission and mortality in patients with ischemic stroke: investigating the effects of a pulmonary rehabilitation program. BMC Neurol. 2017 Jul 11;17(1):132. doi: 10.1186/s12883-017-0912-4.
- Individual participant dataSharing planned: No. The datasets during and/or analysed during the current study available from the corresponding author on reasonable request.
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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.
Abdulkadir TUNÇ, MD principal investigator
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Ischemic and Intensive Care Neurological Disorder, run by Abdulkadir Tunc 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 7 inclusion and 6 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 22 Jun 2017. 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. 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?
Intensive care unit admission (time frame: 3 months). 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 NCT03195907, which also lists 6 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 22 Jun 2017.