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

December 10, 2019 updated by: Rehab Abdelaal ELnemr, Alexandria University

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

Study Overview

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:

  1. Primary outcome:

    • The diagnosis of pneumonia within the first 7 days after admission. (Diagnosis will be made according to modified criteria of the CDC

  2. Secondary outcome:

    • In-hospital or 30 days mortality.
    • Modified Rankin Scale (mRS) at one month.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Alexandria, Egypt, 123456
        • Recruiting
        • Rehab Abdelaal ELnemr
        • Contact:
        • Sub-Investigator:
          • mohamed w elsayed, resident
        • Principal Investigator:
          • Osama S Hassan, lecturer
        • Principal Investigator:
          • Tamer A Helmy, professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2019

Primary Completion (Actual)

November 15, 2019

Study Completion (Anticipated)

January 20, 2020

Study Registration Dates

First Submitted

September 28, 2019

First Submitted That Met QC Criteria

September 30, 2019

First Posted (Actual)

October 1, 2019

Study Record Updates

Last Update Posted (Actual)

December 12, 2019

Last Update Submitted That Met QC Criteria

December 10, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

may be after finishing patient collection

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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