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

NCT ID: NCT04110652

Last Updated: 2019-12-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-03
• Study Completion Date: 2020-01-20

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:

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.

Conditions

Stroke, Acute; Pulmonary Rehabilitation; Morality

Keywords

stroke; rehabilitation; mortality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

pulmonary rehabilitation program

Intervention Type: OTHER

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.

control group

40 patients with acute stroke will receive Stroke management based on the guidelines of the American Heart Association/American Stroke Association.

Group Type: PLACEBO_COMPARATOR

pulmonary rehabilitation program

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mohamed Wahid Elsayed Elsayed

UNKNOWN

Sponsor Role: collaborator

Prof. Dr. Tamer Abdullah Helmy

UNKNOWN

Sponsor Role: collaborator

Dr. Osama Saeed Hassan

UNKNOWN

Sponsor Role: collaborator

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Rehab Abdelaal ELnemr

lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rehab Abdelaal ELnemr

Alexandria, , Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Rehab A ELnemr, lecturer

Role: primary

Other Identifiers

0105838

Identifier Type: -

Identifier Source: org_study_id