Istanbul Florence Nightingale Hospital
Istanbul, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT06258681
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.
Interested in participating?
Request Info40 year–65 year
All sexes
Interventional
Not applicable
Istanbul, Turkey (Türkiye)
Location status: Recruiting
Breathing exercises can be applied specifically to different segments of the lungs, increasing collateral ventilation and helping mobilize secretions. Chronic respiratory diseases, rib cage deformities, neuromuscular diseases that cause breathing problems, lung transplant or lung surgery patients in the pre-operative and post-operative period, cancer patients, heart failure patients and cardiovascular surgery patients, and those whose quality of life is impaired due to shortness of breath. People are known to be groups that benefit from breathing exercises. Breathing exercises have been shown to be effective in preserving respiratory function and preventing or reducing respiratory complications in all of these conditions. It has been reported that respiratory muscle training applied within the scope of pre- and post-operative cardiac rehabilitation programs is beneficial in increasing respiratory functions and reducing the risk of postoperative 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 inspiratory and expiratory muscles, and each training method and device has differences. For this reason, the respiratory exercise device to be developed is aimed to be a device that can be shaped according to the desired purpose, has visual feedback, and can combine multiple respiratory muscle training methods. The device is thought to play an active role in rehabilitating complications such as lung ventilation and respiratory muscle weakness, which are frequently affected in patients after major surgery such as cardiac surgery. 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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Participants will be able to practice both inspiratory and expiratory respiratory muscle training in a single breathing cycle.
Time frame: 8 weeks
The volume of air exhaled in the 1st second of forced expiration will be noted.
Time frame: 8 weeks
The volume of air exhaled rapidly and forcefully following deep inspiration will be noted.
Time frame: 8 weeks
Maximum inspiration followed by maximum exhalation maneuver will be measured and noted.
Time frame: 8 weeks
Inspiratory and expiratory respiratory muscle strength will be evaluated by intraoral pressure measurement method.
Time frame: 8 weeks
Functional capacity evaluation will be done with 6 Minute Walking Test. Six minutes walking distance will be noted.
Time frame: 8 weeks
Quality of life will be assessed using the Minnesota Life with Heart Failure Questionnaire.
Contact information is provided by the study sponsor or research team.
Buket Akinci, Assoc. Prof.
CONTACT
Busra Ulker Eksi, MSc
CONTACT
Biruni University
Other
Examining the Clinical Efficiency of a Customizable Respiratory Exercise Device in Individuals Who Have Undergone Cardiac Surgery
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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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