- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04110652
Effect of Pulmonary Rehabilitation Program on Patients With Acute Ischemic Stroke, Mortality and Disability
Effect of a Pulmonary Rehabilitation Program on Hospital Mortality and Disability in Patients With Acute Ischemic Stroke
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Alexandria, Egypt, 123456
- Recruiting
- Rehab Abdelaal ELnemr
-
Contact:
- Rehab A ELnemr, lecturer
- Phone Number: 01281510109 01281510109
- Email: hobaelnemr@hotmail.com
-
Sub-Investigator:
- mohamed w elsayed, resident
-
Principal Investigator:
- Osama S Hassan, lecturer
-
Principal Investigator:
- Tamer A Helmy, professor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: patient
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.
|
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. |
Placebo Comparator: control group
40 patients with acute stroke will receive Stroke management based on the guidelines of the American Heart Association/American Stroke Association.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
within the first 7 days after admission
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality rate
Time Frame: In-hospital after 30 days
|
Modified Rankin Scale (mRS) at one month
|
In-hospital after 30 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0105838
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pulmonary Rehabilitation
-
University of LisbonCentro Hospitalar Lisboa Norte; Fundação para a Ciência e a TecnologiaCompletedPulmonary RehabilitationPortugal
-
Karen LarimerSunovianTerminatedPulmonary Rehabilitation | COPDUnited States
-
Asan Medical CenterRecruitingPulmonary Rehabilitation | Cardiac RehabilitationKorea, Republic of
-
University Hospital, ToursCompletedPulmonary Rehabilitation | Respiratory RehabilitationFrance
-
Istanbul Medipol University HospitalRecruitingExercise | Pulmonary Rehabilitation | COPDTurkey
-
Istanbul Medipol University HospitalCompletedPulmonary Rehabilitation | Exercise Capacity | Exercise TestTurkey
-
Guangzhou Medical UniversityUnknownPulmonary Rehabilitation | Non-invasive Ventilation | COPChina
-
Asan Medical CenterRecruitingPulmonary Rehabilitation | Cardiac RehabilitationKorea, Republic of
-
Istanbul Medipol University HospitalCompletedEmphysema | Bronchoscopic Lung Volume Reduction | Hospital-based Pulmonary Rehabilitation | Home-based Pulmonary RehabilitationTurkey
-
National Cheng-Kung University HospitalCompletedTelerehabilitation | Pulmonary Rehabilitation | Compliance, Patient | COPD | Cardiopulmonary Exercise TestTaiwan
Clinical Trials on pulmonary rehabilitation program
-
Blue Marble Rehab IncWake Forest University Health SciencesCompleted
-
Fundación Pública Andaluza para la gestión de la...Unknown
-
The Opole University of TechnologyRecruiting
-
University Hospital, LilleTerminated
-
Dartmouth-Hitchcock Medical CenterAmerican Academy of Medical AcupunctureRecruiting
-
Schön Klinik Berchtesgadener LandLungenfibrose e.V.TerminatedIdiopathic Pulmonary Fibrosis and COPDGermany
-
University of RzeszowNot yet recruitingChronic Obstructive Pulmonary DiseasePoland
-
National Jewish HealthNational Heart, Lung, and Blood Institute (NHLBI)CompletedIdiopathic Pulmonary FibrosisUnited States
-
Tilburg UniversityFonds NutsOhra; Revant Schoondonck Center for Pulmonary Rehabilitation Breda; Revant Innovation foundationCompletedChronic Obstructive Pulmonary Disease COPDNetherlands
-
Istituti Clinici Scientifici Maugeri SpARecruiting