Effect of Pulmonary Rehabilitation Program on Patients With Acute Ischemic Stroke, Mortality and Disability
Primary Purpose
Stroke, Acute, Pulmonary Rehabilitation, Morality
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
pulmonary rehabilitation program
Sponsored by
About this trial
This is an interventional supportive care trial for Stroke, Acute focused on measuring stroke, rehabilitation, mortality
Eligibility Criteria
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.
Sites / Locations
- Rehab Abdelaal ELnemrRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
patient
control group
Arm Description
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.
40 patients with acute stroke will receive Stroke management based on the guidelines of the American Heart Association/American Stroke Association.
Outcomes
Primary Outcome Measures
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 Measures
Mortality rate
Modified Rankin Scale (mRS) at one month
Full Information
NCT ID
NCT04110652
First Posted
September 28, 2019
Last Updated
December 10, 2019
Sponsor
Alexandria University
Collaborators
Mohamed Wahid Elsayed Elsayed, Prof. Dr. Tamer Abdullah Helmy, Dr. Osama Saeed Hassan
1. Study Identification
Unique Protocol Identification Number
NCT04110652
Brief Title
Effect of Pulmonary Rehabilitation Program on Patients With Acute Ischemic Stroke, Mortality and Disability
Official Title
Effect of a Pulmonary Rehabilitation Program on Hospital Mortality and Disability in Patients With Acute Ischemic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 3, 2019 (Actual)
Primary Completion Date
November 15, 2019 (Actual)
Study Completion Date
January 20, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University
Collaborators
Mohamed Wahid Elsayed Elsayed, Prof. Dr. Tamer Abdullah Helmy, Dr. Osama Saeed Hassan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute, Pulmonary Rehabilitation, Morality
Keywords
stroke, rehabilitation, mortality
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patient
Arm Type
Active Comparator
Arm Description
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.
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
40 patients with acute stroke will receive Stroke management based on the guidelines of the American Heart Association/American Stroke Association.
Intervention Type
Other
Intervention Name(s)
pulmonary rehabilitation program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary outcome: The diagnosis of pneumonia within the first 7 days after admission.
Description
Diagnosis will be made according to modified criteria of the CDC
Time Frame
within the first 7 days after admission
Secondary Outcome Measure Information:
Title
Mortality rate
Description
Modified Rankin Scale (mRS) at one month
Time Frame
In-hospital after 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Rehab Abdelaal ELnemr
City
Alexandria
ZIP/Postal Code
123456
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rehab A ELnemr, lecturer
Phone
01281510109
Ext
01281510109
Email
hobaelnemr@hotmail.com
First Name & Middle Initial & Last Name & Degree
mohamed w elsayed, resident
First Name & Middle Initial & Last Name & Degree
Osama S Hassan, lecturer
First Name & Middle Initial & Last Name & Degree
Tamer A Helmy, professor
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
may be after finishing patient collection
Learn more about this trial
Effect of Pulmonary Rehabilitation Program on Patients With Acute Ischemic Stroke, Mortality and Disability
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