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NCT Number: NCT06258681

Customizable Respiratory Exercise Device in Individuals Who Have Undergone Cardiac Surgery

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.

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Florence Nightingale Hospital

Istanbul, Turkey (Türkiye)

Location status: Recruiting

Location contact

Busra Ulker Eksi

CONTACT

[email protected]

+90 212 444 8 276

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

incentive spirometer

Other

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

Other

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

Primary outcomes

  1. The Forced Expiratory Volume 1st second

    Time frame: 8 weeks

    The volume of air exhaled in the 1st second of forced expiration will be noted.

  2. Forced Vital Capacity

    Time frame: 8 weeks

    The volume of air exhaled rapidly and forcefully following deep inspiration will be noted.

  3. Peak Expiratory Flow

    Time frame: 8 weeks

    Maximum inspiration followed by maximum exhalation maneuver will be measured and noted.

  4. Respiratory Muscle Strength

    Time frame: 8 weeks

    Inspiratory and expiratory respiratory muscle strength will be evaluated by intraoral pressure measurement method.

  5. Six minutes walking test

    Time frame: 8 weeks

    Functional capacity evaluation will be done with 6 Minute Walking Test. Six minutes walking distance will be noted.

Secondary outcomes

  1. Minnesota Life with Heart Failure Questionnaire.

    Time frame: 8 weeks

    Quality of life will be assessed using the Minnesota Life with Heart Failure Questionnaire.

Study contacts

Contact information is provided by the study sponsor or research team.

Buket Akinci, Assoc. Prof.

CONTACT

[email protected]

+90 212 444 8 276

Busra Ulker Eksi, MSc

CONTACT

[email protected]

+90 212 444 8 276

Sponsors and collaborators

Lead sponsor

Biruni University

Other

Collaborators

  • Istanbul Galata University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 14, 2024
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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