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| Name | Class |
|---|---|
| Istanbul Galata University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Incentive spirometry group | Active Comparator | The incentive spirometry group will continue the 8-week training with Volumetric Triflo. Individuals will be expected to exhale normally and hold their breath for at least 3 seconds after taking as deep a breath as possible. In the first week after surgery, the individual will be asked to work with an incentive spirometry in 10 repetitions every hour when awake. The group also followed standard program which includes phases of chest physiotherapy (modified postural drainage and assisted coughing techniques) and early progressive mobilization (gradually increasing walking distance in the corridor depending on patient tolerance). Participants in both groups will continue aerobic exercise training in the clinic until the end of the 8th week after discharge. Aerobic exercise training includes a bicycle ergometer, two days a week, 20-30 minutes, and perceived effort in the range of 60-70% of the maximal heart rate, in the range of 4-6 according to the Modified Borg Scale. |
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| Individualized respiratory training group | Experimental | In the first week after surgery, the personalized breathing exercise device will be adjusted to the resistance level corresponding to 40% of the initial pressure load, MIP, and MEP measurements. Participants will be asked to rest and repeat the training for ten sets following five breathing cycles. In each set, there will be a one-minute rest break between repetitions. Participants can practice both inspiratory and expiratory respiratory muscle training in a single breathing cycle. As the progression progresses, the perceived exertion level will be increased by 5-10% every week to a range of 4-6 according to the Modified Borg Scale. The training will continue for eight weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The Forced Expiratory Volume 1st second | The volume of air exhaled in the 1st second of forced expiration will be noted. | 8 weeks |
| Forced Vital Capacity | The volume of air exhaled rapidly and forcefully following deep inspiration will be noted. | 8 weeks |
| Peak Expiratory Flow | Maximum inspiration followed by maximum exhalation maneuver will be measured and noted. | 8 weeks |
| Respiratory Muscle Strength | Inspiratory and expiratory respiratory muscle strength will be evaluated by intraoral pressure measurement method. | 8 weeks |
| Six minutes walking test | Functional capacity evaluation will be done with 6 Minute Walking Test. Six minutes walking distance will be noted. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Minnesota Life with Heart Failure Questionnaire. | Quality of life will be assessed using the Minnesota Life with Heart Failure Questionnaire. | 8 weeks |
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Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Buket Akinci, Assoc. Prof. | Contact | +90 212 444 8 276 | bakinci@biruni.edu.tr | |
| Busra Ulker Eksi, MSc | Contact | +90 212 444 8 276 | bbusraulker@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mehmet Ezelsoy, MSc | Bilim University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul Florence Nightingale Hospital | Recruiting | Istanbul | Istanbul | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42386010 | Derived | Eksi BU, Cilbir CE, Ucgun H, Ertan Harputlu O, Aslan GK, Ezelsoy M, Ugurlucan M, Sagbas LE, Akinci B. Effects of integrated inspiratory-expiratory muscle training within hybrid cardiac rehabilitation following cardiac surgery: A randomized controlled study. Respir Med. 2026 Jul 1;261:109018. doi: 10.1016/j.rmed.2026.109018. Online ahead of print. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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This is a two-arm controlled single blind trial.
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The assessor will be blind to the group allocation and participants will be blind to the intervention.
| Individualized respiratory training group | Other | Participants will be able to practice both inspiratory and expiratory respiratory muscle training in a single breathing cycle. |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |