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

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Egypt
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alexandria University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Mohamed Wahid Elsayed Elsayed
Prof. Dr. Tamer Abdullah Helmy
Dr. Osama Saeed Hassan

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 3, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 20, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 12, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0105838

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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