Actively Recruiting

Phase Not Applicable
Age: 40Years - 65Years
All Genders
Healthy Volunteers
NCT06258681

Customizable Respiratory Exercise Device in Individuals Who Have Undergone Cardiac Surgery

Led by Biruni University · Updated on 2025-02-07

20

Participants Needed

1

Research Sites

65 weeks

Total Duration

On this page

Sponsors

B

Biruni University

Lead Sponsor

I

Istanbul Galata University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Customizable Respiratory Exercise Device in Individuals Who Have Undergone Cardiac Surgery

Who Can Participate

Age: 40Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals with New York Heart Association Functional Class I or II scheduled for elective coronary artery bypass graft surgery, aortic valve replacement, mitral valve replacement, or combined aortic and mitral valve replacement
  • Individuals planning to undergo surgery using the median sternotomy technique
  • Individuals with Mini-Mental State Score greater than 24
Not Eligible

You will not qualify if you...

  • Individuals with uncontrolled arrhythmia, unstable angina pectoris, or uncontrolled hypertension
  • Individuals with chronic respiratory disease
  • Individuals with neuromuscular or orthopedic/musculoskeletal limitations
  • Individuals with history of spontaneous or trauma-related pneumothorax
  • Individuals with middle ear-related pathologies such as tympanic membrane rupture or otitis
  • Individuals with thorax drains in the ward
  • Individuals who stayed in the intensive care unit for 4 or more days postoperatively
  • Individuals who had another surgery in the last six months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Istanbul Florence Nightingale Hospital

Istanbul, Istanbul, Turkey (Türkiye)

Actively Recruiting

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Research Team

B

Buket Akinci, Assoc. Prof.

CONTACT

B

Busra Ulker Eksi, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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