Pulmonary Physiotherapy for Ischemic Stroke

June 21, 2017 updated by: Abdulkadir Tunc

Predictors of Intensive Care Unit Admission and Mortality in Patients With Ischemic Stroke: Investigating the Effects of a Pulmonary Rehabilitation Program

This study evaluates the predictors of intensive care unit admission and mortality among stroke patients and the effects of pulmonary physiotherapy on these stroke patients. One-hundred patients participated in the pulmonary rehabilitation program and 81 patients served as a control group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Predicting early mortality and disability after a stroke depends on many factors, such as age, the type of stroke, lesional location, level of consciousness, severity of neurological impairment, medical risk factors (hypertension and diabetes), premorbid conditions, fever and history of stroke. Stroke patients may experience a reduction of up to 50% in respiratory function when compared to age- and gender-matched norms. The reduction in respiratory function can lead to decreased endurance, dyspnoea and increased sedentary behaviour, as well as an elevated risk of stroke. The reduction in respiratory function may also cause aspiration, leading to pneumonia.

The aim of pulmonary rehabilitation program is to enhance respiratory muscle resistance during breathing, thereby improving respiratory function. Pulmonary rehabilitation programs are considered to be capable of inducing positive effects on stroke patients' respiratory muscles through diaphragm breathing exercise and lip puckering breathing exercise. Pulmonary physiotherapy (PPT) improves the quality of life of stroke patients.

The PPT program was conducted by physical therapists at our hospital for 30 min, three days/week. As part of the PPT, a physiotherapist monitored this group for 12 weeks. The same physiotherapist supervised all the exercises. During the exercise program, all patients were clinically stable and all were receiving optimal medical therapy. Rehabilitation started with inspiratory diaphragm breathing exercises. The physiotherapist placed his hands on the superior rectus abdominis immediately below the anterior costal cartilage and induced inspiratory diaphragm breathing by instructing the patient to slowly and deeply inhale the air through the nose. Then the patient was instructed to perform expiratory pursed-lip breathing exercise by continuously exhale the air. During pursed-lip breathing exercise, the patient was instructed in sequence, to breathe in gently through the nose, purse his/ her lips as though whistling and then breathe out through the long pursed lips by not exerting power until she/ he is short of breath. The expiration time was set to be at least twice times longer than inspiration time. The patients took a rest when they complained about fatigue or dizziness during breathing exercise and conducted breathing exercise again. The exercise intensity was based on the maximal heart rate and maximal effort of the patients. Each patient's performance during the exercise sessions was recorded and reported regularly to the patient's physician. National Institute of Health Stroke Scale scores, modified Rankin scale scores, pneumonia onset, admission to the intensive care unit and mortality were recorded at the end of the first and third month.

Study Type

Observational

Enrollment (Actual)

181

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

  • Turkey
    • Serdivan
      • Sakarya, Serdivan, Turkey, 54050
        • Sakarya University

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

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who were admitted to the neurology clinic stroke unit or the neurological intensive care unit

Description

Inclusion Criteria:

  • acute ischemic stroke confirmed by computed tomography or a diffusion-weighed magnetic resonance imaging scan,
  • aged > 40 years,
  • ability to understand and follow simple verbal instructions,
  • modified Rankin scale score > 2,
  • National Institute of Health Stroke Scale score > 0,
  • no unrestricted movement of the lips,
  • no receptive aphasia and no history of thoracic or abdominal surgery.

Exclusion Criteria:

  • blood pressure >180/100 mm Hg more than twice in 24 h;
  • significant pulmonary disease, angina, myocardial infarction or acute heart failure within three months;
  • neurological conditions other than stroke;
  • presence of a severe visual disability and visual field defects;
  • receiving medications that would influence the metabolic or cardiorespiratory responses to exercise;
  • inability to perform the tests.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PPT group
Those participated in pulmonary rehabilitation program
Other: Pulmonary physiotherapy
Control group
Those served as control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intensive care unit admission
Time Frame: 3 months
Patients who require mechanical ventilation were admitted to the neurological intensive care unit
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality rates
Time Frame: 3 months
Mortality rates after stroke
3 months
Assessment of stroke severity
Time Frame: 3 months
Evaluated with National Institute of Health Stroke Scale in both groups
3 months
Assessment of functional disability
Time Frame: 3 months
Evaluated with modified Rankin scale in both groups
3 months
Pneumonia onset
Time Frame: 3 months
Pulmonary onset rates
3 months

Collaborators and Investigators

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

Sponsor

Abdulkadir Tunc

Investigators

  • Principal Investigator: Abdulkadir TUNÇ, MD, Bezmialem Vakif University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

June 20, 2017

First Submitted That Met QC Criteria

June 21, 2017

First Posted (Actual)

June 22, 2017

Study Record Updates

Last Update Posted (Actual)

June 22, 2017

Last Update Submitted That Met QC Criteria

June 21, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • StrokePPT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The datasets during and/or analysed during the current study available from the corresponding author on reasonable request.

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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