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

NCT04110652 | Unknown DMC

• 1 other identifier: 0105838
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Stroke, Acute; Pulmonary Rehabilitation; Morality

Keywords

stroke; rehabilitation; mortality

Outcome Measures

Primary Outcomes (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

  within the first 7 days after admission

Secondary Outcomes (1)

• Mortality rate

  In-hospital after 30 days

Study Arms (2)

patient

ACTIVE COMPARATOR

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

control group

PLACEBO COMPARATOR

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

Interventions

pulmonary rehabilitation program 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; patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (≥18 years old).
• With Acute Ischemic Stroke

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead
• Mohamed Wahid Elsayed Elsayed: collaborator
• Prof. Dr. Tamer Abdullah Helmy: collaborator
• Dr. Osama Saeed Hassan: collaborator

Study Sites (1)

Rehab Abdelaal ELnemr

Alexandria, 123456, Egypt

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: September 28, 2019
• First Posted: October 1, 2019
• Study Start: February 3, 2019
• Primary Completion: November 15, 2019
• Study Completion: January 20, 2020
• Last Updated: December 12, 2019

Record last verified: 2019-12

Locations

EG (1)