NCT06258681Recruiting
Customizable Respiratory Exercise Device in Individuals Who Have Undergone Cardiac Surgery
Examining the Clinical Efficiency of a Customizable Respiratory Exercise Device in Individuals Who Have Undergone Cardiac Surgery
Source: ClinicalTrials.gov · Last updated 7 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 26 Jan 2024
- Start date
- 28 Feb 2024
- Primary completion date
- 30 May 2025
- Lead sponsor
- Biruni University
- Diseases
- Coronary artery disease
- NCT number
- NCT06258681
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 28 Feb 2024 to the primary completion date, 30 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Individuals who have had another surgery in the last six months
Other illness
- Individuals with uncontrolled arrhythmia, unstable angina pectoris, uncontrolled hypertension
- Individuals with accompanying chronic respiratory disease
- Individuals with a history of spontaneous or trauma-related pneumothorax
Other
- Individuals with accompanying neuromuscular or orthopedic/musculoskeletal limitations
- 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
Who the study is looking for
- 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
Age in the registry: 40 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Istanbul Florence Nightingale Hospital Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.