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Effect of Pulmonary Rehabilitation Program on Patients With Acute Ischemic Stroke, Mortality and Disability

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04110652
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : December 12, 2019
Sponsor:
Collaborators:
Mohamed Wahid Elsayed Elsayed
Prof. Dr. Tamer Abdullah Helmy
Dr. Osama Saeed Hassan
Information provided by (Responsible Party):
Rehab Abdelaal ELnemr, Alexandria University

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

Condition or disease Intervention/treatment Phase
Stroke, Acute Pulmonary Rehabilitation Morality Other: pulmonary rehabilitation program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of a Pulmonary Rehabilitation Program on Hospital Mortality and Disability in Patients With Acute Ischemic Stroke
Actual Study Start Date : February 3, 2019
Actual Primary Completion Date : November 15, 2019
Estimated Study Completion Date : January 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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.
Other: 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.
Other: 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.





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Mortality rate [ Time Frame: In-hospital after 30 days ]
    Modified Rankin Scale (mRS) at one month



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04110652


Locations
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Egypt
Rehab Abdelaal ELnemr Recruiting
Alexandria, Egypt, 123456
Contact: Rehab A ELnemr, lecturer    01281510109 ext 01281510109    hobaelnemr@hotmail.com   
Sub-Investigator: mohamed w elsayed, resident         
Principal Investigator: Osama S Hassan, lecturer         
Principal Investigator: Tamer A Helmy, professor         
Sponsors and Collaborators
Alexandria University
Mohamed Wahid Elsayed Elsayed
Prof. Dr. Tamer Abdullah Helmy
Dr. Osama Saeed Hassan
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Responsible Party: Rehab Abdelaal ELnemr, lecturer, Alexandria University
ClinicalTrials.gov Identifier: NCT04110652    
Other Study ID Numbers: 0105838
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: December 12, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: may be after finishing patient collection

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rehab Abdelaal ELnemr, Alexandria University:
stroke
rehabilitation
mortality
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases