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Pulmonary Physiotherapy for Ischemic Stroke

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03195907
First Posted: June 22, 2017
Last Update Posted: June 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Abdulkadir Tunc, Bezmialem Vakif University
  Purpose
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.

Condition Intervention
Stroke, Ischemic Intensive Care Neurological Disorder Morality Rehabilitation Other: Pulmonary physiotherapy

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Predictors of Intensive Care Unit Admission and Mortality in Patients With Ischemic Stroke: Investigating the Effects of a Pulmonary Rehabilitation Program

Resource links provided by NLM:


Further study details as provided by Abdulkadir Tunc, Bezmialem Vakif University:

Primary Outcome Measures:
  • Intensive care unit admission [ Time Frame: 3 months ]
    Patients who require mechanical ventilation were admitted to the neurological intensive care unit


Secondary Outcome Measures:
  • Mortality rates [ Time Frame: 3 months ]
    Mortality rates after stroke

  • Assessment of stroke severity [ Time Frame: 3 months ]
    Evaluated with National Institute of Health Stroke Scale in both groups

  • Assessment of functional disability [ Time Frame: 3 months ]
    Evaluated with modified Rankin scale in both groups

  • Pneumonia onset [ Time Frame: 3 months ]
    Pulmonary onset rates


Enrollment: 181
Actual Study Start Date: February 1, 2015
Study Completion Date: January 1, 2016
Primary Completion Date: January 1, 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
PPT group
Those participated in pulmonary rehabilitation program
Other: Pulmonary physiotherapy
Control group
Those served as control group

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.

  Eligibility

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who were admitted to the neurology clinic stroke unit or the neurological intensive care unit
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195907


Locations
Turkey
Sakarya University
Sakarya, Serdivan, Turkey, 54050
Sponsors and Collaborators
Abdulkadir Tunc
Investigators
Principal Investigator: Abdulkadir TUNÇ, MD Bezmialem Vakif University
  More Information

Publications:
Responsible Party: Abdulkadir Tunc, Neurologist, Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT03195907     History of Changes
Other Study ID Numbers: StrokePPT
First Submitted: June 20, 2017
First Posted: June 22, 2017
Last Update Posted: June 22, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The datasets during and/or analysed during the current study available from the corresponding author on reasonable request.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Abdulkadir Tunc, Bezmialem Vakif University:
Stroke
Mortality
Intensive care unit
Pulmonary rehabilitation

Additional relevant MeSH terms:
Stroke
Ischemia
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes