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Customizable Respiratory Exercise Device in Individuals Who Have Undergone Cardiac Surgery

RecruitingNAAges 40 Years - 65 YearsAllBiruni University
NCT06258681 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The cardiorespiratory system integrates systemic and pulmonary circulation while ensuring adequate oxygenation of the body at rest and during exercise. In addition to chronic respiratory problems that mainly affect the lungs, airways and pulmonary vascular system, respiratory capacity and respiratory muscle strength can be negatively affected in a wide spectrum including cardiac diseases, surgeries, neuromuscular diseases, obesity, long-term bed rest, aging and inactivity. Weakness of the respiratory muscles causes important secondary consequences by causing the increased respiratory demands not to be met during physical activity. It has been reported that respiratory muscle training applied within the scope of pre-operative and post-operative cardiac rehabilitation program is beneficial in terms of increasing respiratory functions, reducing the risk of post-operative complications and l

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📋 Eligibility rules (as published)
Inclusion criteria * Individuals with New York Heart Association Functional Class I or II who are scheduled to undergo elective coronary artery bypass graft surgery, aortic valve replacement, mitral valve replacement, or combined surgery of aortic and mitral valve replacement * Individuals who are planning to undergo surgery with the median sternotomy technique * Individuals with Mini-Mental State Score \>24 Exclusion criteria * Individuals with uncontrolled arrhythmia, unstable angina pectoris, uncontrolled hypertension * Individuals with accompanying chronic respiratory disease * Individuals with accompanying neuromuscular or orthopedic/musculoskeletal limitations * Individuals with a history of spontaneous or trauma-related pneumothorax * Individuals with middle ear-related pathologies (such as tympanic membrane rupture otitis) * Cases with thorax drains in the ward * Individuals who stayed in the intensive care unit for ≥ 4 days in the postoperative period * Individuals who have had another surgery in the last six months
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What it tests

  • Incentive spirometer
  • Individualized respiratory training group
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Where

1 site
Istanbul Florence Nightingale Hospital
Istanbul, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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