Customizable Respiratory Exercise Device in Individuals Who Have Undergone Cardiac Surgery

Coronary Artery Disease Clinical Trial

Official title:

Examining the Clinical Efficiency of a Customizable Respiratory Exercise Device in Individuals Who Have Undergone Cardiac Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06258681
• Other study ID #: 682201
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 28, 2024
• Est. completion date: May 30, 2025

Study information

• Verified date: February 2024
• Source: Biruni University
• Contact: Buket Akinci, Assoc. Prof.
• Phone: +90 212 444 8 276
• Email: bakinci[@]biruni.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: May 30, 2025
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Biruni University	Istanbul Galata University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Forced Expiratory Volume 1st second	The volume of air exhaled in the 1st second of forced expiration will be noted.	8 weeks
Primary	Forced Vital Capacity	The volume of air exhaled rapidly and forcefully following deep inspiration will be noted.	8 weeks
Primary	Peak Expiratory Flow	Maximum inspiration followed by maximum exhalation maneuver will be measured and noted.	8 weeks
Primary	Respiratory Muscle Strength	Inspiratory and expiratory respiratory muscle strength will be evaluated by intraoral pressure measurement method.	8 weeks
Primary	Six minutes walking test	Functional capacity evaluation will be done with 6 Minute Walking Test. Six minutes walking distance will be noted.	8 weeks
Secondary	Minnesota Life with Heart Failure Questionnaire.	Quality of life will be assessed using the Minnesota Life with Heart Failure Questionnaire.	8 weeks