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Clinical Trials in Turkey / NCT06258681
Recruiting Not applicable

Customizable Respiratory Exercise Device in Individuals Who Have Undergone Cardiac Surgery

NCT06258681 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2024-02-28
Last updated
2025-02-07

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

Incentive spirometerIndividualized respiratory training group

Incentive spirometer: The incentive spirometry group will continue training with Volumetric Triflo. It is asked to exhale at first and then hold their breath for at least 3 seconds after taking as deep a breath as possible.

Individualized respiratory training group: Participants will be able to practice both inspiratory and expiratory respiratory muscle training in a single breathing cycle.

Study summary

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.

Eligibility

Sex
ALL
Min age
40 Years
Max age
65 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Istanbul Florence Nightingale Hospital Istanbul Istanbul Recruiting

More Biruni University trials in Turkey

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06258681 on ClinicalTrials.gov ↗ ← All trials in Turkey