Customizable Respiratory Exercise Device in Individuals Who Have Undergone Cardiac Surgery

Recruiting now · Not applicable

Conditions studied: Coronary Artery Disease

In brief

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 length of stay. Respiratory muscle training is known to have many potential beneficial effects on patients undergoing cardiac surgery. Different methods and devices are used to improve and develop the functions of the inspiratory and expiratory muscles and each training method and device has differences. Therefore, it is thought that examining the clinical effects of using a personalized breathing exercise device on respiratory functions, respiratory muscle strength and functional capacity in individuals who have undergone cardiac surgery will contribute to the literature.

Key facts

Study ID

NCT06258681

Run by

Biruni University

People needed

20

Starts

2024-02-28

Expected to finish

2025-05-30

Last updated by the study team

2025-02-07

Who can join

Age: 40 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Istanbul Florence Nightingale Hospital — Istanbul, Istanbul, Turkey (Türkiye) (enrolling)

Full record on ClinicalTrials.gov

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