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NCT Number: NCT03195907

Pulmonary Physiotherapy for Ischemic Stroke

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.

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Key information

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sakarya University

Sakarya, Serdivan, 54050, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pulmonary physiotherapy

Other

Primary outcomes

  1. Intensive care unit admission

    Time frame: 3 months

    Patients who require mechanical ventilation were admitted to the neurological intensive care unit

Secondary outcomes

  1. Mortality rates

    Time frame: 3 months

    Mortality rates after stroke

  2. Assessment of stroke severity

    Time frame: 3 months

    Evaluated with National Institute of Health Stroke Scale in both groups

  3. Assessment of functional disability

    Time frame: 3 months

    Evaluated with modified Rankin scale in both groups

  4. Pneumonia onset

    Time frame: 3 months

    Pulmonary onset rates

Sponsors and collaborators

Lead sponsor

Abdulkadir Tunc

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 22, 2017
Registry last updated
Jun 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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