Stroke, AcuteNCT04110652
Effect of Pulmonary Rehabilitation Program on Patients With Acute Ischemic Stroke, Mortality and Disability
A study testing pulmonary rehabilitation program in people with Stroke, Acute and Pulmonary Rehabilitation, run by Alexandria University at 1 site in Egypt.
Trial summary
Severe stroke remains an important cause of mortality and morbidity, despite advances in disease management, acute treatment and secondary measures. Among all post-stroke complications, pneumonia constitutes a major complication with a strong impact on morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute, Pulmonary Rehabilitation, Morality
- What is being tested?
- pulmonary rehabilitation program
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Feb 2019to 20 Jan 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (≥18 years old).
- With Acute Ischemic Stroke
Who cannot join
- Hemorrhagic stroke.
- GCS < 7 on admission.
- Clinical signs of infection on admission.
- Significant pulmonary disease, angina, myocardial infarction or acute heart failure within three months.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Rehab Abdelaal ELnemr
Alexandria, 123456
Rehab A ELnemr, lecturer, 01281510109 ext. 01281510109, hobaelnemr@hotmail.com
mohamed w elsayed, resident
About this study
Official title: Effect of a Pulmonary Rehabilitation Program on Hospital Mortality and Disability in Patients With Acute Ischemic Stroke
Severe stroke remains an important cause of mortality and morbidity, despite advances in disease management, acute treatment and secondary measures. Among all post-stroke complications, pneumonia constitutes a major complication with a strong impact on morbidity and mortality. Research also showed that a reduction in respiratory muscle and abdominal muscle strength contributed to pulmonary and respiratory dysfunction following a stroke. Low respiratory muscle function decreases the efficacy of rehabilitation because it leads to exercise intolerance in stroke patients. Thus, special exercise programs are needed to improve the pulmonary function and respiratory muscle strength of stroke patients The aim of pulmonary rehabilitation program is to enhance respiratory muscle resistance during breathing, thereby improving respiratory function. Previous studies demonstrated that pulmonary rehabilitation programs improved respiratory functions in cardiac disease and chronic obstructive pulmonary disease patients
Read the detailed description
The study will be conducted on 80 adult patients with Acute Ischemic Stroke.
Inclusion criteria:
- Adult (≥18 years old).
- With Acute Ischemic Stroke.
Exclusion criteria:
- Hemorrhagic stroke.
- GCS < 7 on admission.
- Clinical signs of infection on admission.
- Significant pulmonary disease, angina, myocardial infarction or acute heart failure within three months.
For every eligible patient the following data will be collected:
- Demographic data including age \& sex.
- Vital signs.
- Glasgow Coma Score on admission after primary respiratory and hemodynamic stabilization.
- Stroke severity on admission assessed by the National Institute of Health Stroke Scale (NIHSS).
- All patients will undergo a CT scan of the brain on admission. Diagnostic procedures such as Doppler ultrasound of the carotid arteries, MRI, and echocardiography will be ordered if deemed necessary by the treating physician.
- Stroke subtype classification utilizing both the TOAST (Trial of ORG 10172 in Acute Stroke Treatment) method and The Oxfordshire Community Stroke Project.
- Pre-existing comorbid conditions (any treatment and/or patient's self-report): Hypertension, Diabetes Mellitus, Atrial Fibrillation, COPD, CHF, and Current Smoking.
- Evidence for any type of dysphagia documented by a standardized dysphagia screening test.
- Laboratory data: White Blood Cell (WBC) Count, C-reactive Protein (CRP), and Blood Glucose will be done daily.
Grouping The patients will be randomized into 2 groups by conventional method of randomization where patients in group 1 (control group) will be selected in odd numbers and those in group 2 (patients receiving pulmonary rehabilitation program) will be selected in even numbers.
Stroke management Group 1: (Control group) 40 patients will receive Stroke management based on the guidelines of the American Heart Association/American Stroke Association.
Group 2: (Patients receiving pulmonary rehabilitation program) 40 patients will receive Stroke management based on the guidelines of the American Heart Association/American Stroke Association in addition to pulmonary rehabilitation program.
Enrolled patients will be prospectively followed up for:
- Primary outcome:
- The diagnosis of pneumonia within the first 7 days after admission. (Diagnosis will be made according to modified criteria of the CDC
- Secondary outcome:
- In-hospital or 30 days mortality.
- Modified Rankin Scale (mRS) at one month.
- Conditions
- Stroke, Acute, Pulmonary Rehabilitation, Morality
- Being tested
- pulmonary rehabilitation program
- Keywords
- stroke, rehabilitation, mortality
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulmonary rehabilitation programOther
The pulmonary rehabilitation program consisting of inspiratory muscle training, manual hyperinflation. chest wall mobilization, rib-cage compression, cough function training, postural drainage and secretion removal will be applied to patient group.
The program will be conducted by physical therapists for 30-45 minutes daily during ICU stay.
The exercise intensity will be increased gradually over the course. Each patient's performance during the exercise sessions will be recorded and reported regularly.
| Study group | Role | What they receive |
|---|---|---|
| patient | Active comparator | 40 patients with acute stroke will receive Stroke management based on the guidelines of the American Heart Association/American Stroke Association.(20-22) in addition to pulmonary rehabilitation program. Receives: Other: pulmonary rehabilitation program |
| control group | Placebo comparator | 40 patients with acute stroke will receive Stroke management based on the guidelines of the American Heart Association/American Stroke Association. Receives: Other: pulmonary rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome: The diagnosis of pneumonia within the first 7 days after admission.
Diagnosis will be made according to modified criteria of the CDC
Measured: within the first 7 days after admission
Secondary outcomes (1)
Mortality rate
Modified Rankin Scale (mRS) at one month
Measured: In-hospital after 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start3 Feb 2019
- Primary completion15 Nov 2019
- Study completion20 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Collaborators
- Mohamed Wahid Elsayed Elsayed, Prof. Dr. Tamer Abdullah Helmy, Dr. Osama Saeed Hassan
- Responsible party
- Principal investigator, Rehab Abdelaal ELnemr, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04110652
- Sponsor's protocol ID
- 0105838
- Status last verified
- Dec 2019
- First submitted
- 28 Sep 2019
- Last updated
- 12 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: may be after finishing patient collection
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Pulmonary Rehabilitation Program on Hospital Mortality and Disability in Patients With Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT04110652
- Acronym / sponsor ID
- 0105838
- Conditions
- Stroke, Acute, Pulmonary Rehabilitation, Morality
- Keywords
- stroke, rehabilitation, mortality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Collaborators
- Mohamed Wahid Elsayed Elsayed, Prof. Dr. Tamer Abdullah Helmy, Dr. Osama Saeed Hassan
- Study start
- 3 Feb 2019 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 20 Jan 2020 (estimated)
- First posted
- 1 Oct 2019 (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.
Severe stroke remains an important cause of mortality and morbidity, despite advances in disease management, acute treatment and secondary measures. Among all post-stroke complications, pneumonia constitutes a major complication with a strong impact on morbidity and mortality. Research also showed that a reduction in respiratory muscle and abdominal muscle strength contributed to pulmonary and respiratory dysfunction following a stroke. Low respiratory muscle function decreases the efficacy of rehabilitation because it leads to exercise intolerance in stroke patients. Thus, special exercise programs are needed to improve the pulmonary function and respiratory muscle strength of stroke patients The aim of pulmonary rehabilitation program is to enhance respiratory muscle resistance during breathing, thereby improving respiratory function. Previous studies demonstrated that pulmonary rehabilitation programs improved respiratory functions in cardiac disease and chronic obstructive pulmonary disease patients
Detailed description
The study will be conducted on 80 adult patients with Acute Ischemic Stroke.
Inclusion criteria:
- Adult (≥18 years old).
- With Acute Ischemic Stroke.
Exclusion criteria:
- Hemorrhagic stroke.
- GCS < 7 on admission.
- Clinical signs of infection on admission.
- Significant pulmonary disease, angina, myocardial infarction or acute heart failure within three months.
For every eligible patient the following data will be collected:
- Demographic data including age \& sex.
- Vital signs.
- Glasgow Coma Score on admission after primary respiratory and hemodynamic stabilization.
- Stroke severity on admission assessed by the National Institute of Health Stroke Scale (NIHSS).
- All patients will undergo a CT scan of the brain on admission. Diagnostic procedures such as Doppler ultrasound of the carotid arteries, MRI, and echocardiography will be ordered if deemed necessary by the treating physician.
- Stroke subtype classification utilizing both the TOAST (Trial of ORG 10172 in Acute Stroke Treatment) method and The Oxfordshire Community Stroke Project.
- Pre-existing comorbid conditions (any treatment and/or patient's self-report): Hypertension, Diabetes Mellitus, Atrial Fibrillation, COPD, CHF, and Current Smoking.
- Evidence for any type of dysphagia documented by a standardized dysphagia screening test.
- Laboratory data: White Blood Cell (WBC) Count, C-reactive Protein (CRP), and Blood Glucose will be done daily.
Grouping The patients will be randomized into 2 groups by conventional method of randomization where patients in group 1 (control group) will be selected in odd numbers and those in group 2 (patients receiving pulmonary rehabilitation program) will be selected in even numbers.
Stroke management Group 1: (Control group) 40 patients will receive Stroke management based on the guidelines of the American Heart Association/American Stroke Association.
Group 2: (Patients receiving pulmonary rehabilitation program) 40 patients will receive Stroke management based on the guidelines of the American Heart Association/American Stroke Association in addition to pulmonary rehabilitation program.
Enrolled patients will be prospectively followed up for:
- Primary outcome:
- The diagnosis of pneumonia within the first 7 days after admission. (Diagnosis will be made according to modified criteria of the CDC
- Secondary outcome:
- In-hospital or 30 days mortality.
- Modified Rankin Scale (mRS) at one month.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient | Active comparator | Other: pulmonary rehabilitation program40 patients with acute stroke will receive Stroke management based on the guidelines of the American Heart Association/American Stroke Association.(20-22) in addition to pulmonary rehabilitation program. |
| control group | Placebo comparator | Other: pulmonary rehabilitation program40 patients with acute stroke will receive Stroke management based on the guidelines of the American Heart Association/American Stroke Association. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult (≥18 years old).
- With Acute Ischemic Stroke
Key exclusion criteria (4 listed)
- Hemorrhagic stroke.
- GCS < 7 on admission.
- Clinical signs of infection on admission.
- Significant pulmonary disease, angina, myocardial infarction or acute heart failure within three months.
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 rehabilitation programThe pulmonary rehabilitation program consisting of inspiratory muscle training, manual hyperinflation. chest wall mobilization, rib-cage compression, cough function training, postural drainage and secretion removal will be applied to patient group. The program will be conducted by physical therapists for 30-45 minutes daily during ICU stay. The exercise intensity will be increased gradually over the course. Each patient's performance during the exercise sessions will be recorded and reported regularly. | Other | control group, patient |
Primary outcome
Primary outcome: The diagnosis of pneumonia within the first 7 days after admission.
Time frame: within the first 7 days after admission
Diagnosis will be made according to modified criteria of the CDC
1 secondary outcome
Mortality rate
Time frame: In-hospital after 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- Individual participant dataSharing planned: Undecided. may be after finishing patient collection
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulmonary rehabilitation program in people with Stroke, Acute and Pulmonary Rehabilitation, run by Alexandria University at 1 site in Egypt.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 12 Dec 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome: The diagnosis of pneumonia within the first 7 days after admission. (time frame: within the first 7 days after admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2019.