Customizable Respiratory Exercise Device in Individuals Who Have Undergone Cardiac Surgery

February 5, 2025 updated by: Buket AKINCI, Biruni University

Examining the Clinical Efficiency of a 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Recruiting
        • Istanbul Florence Nightingale Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Incentive spirometry group
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.
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.
Experimental: Individualized respiratory training group
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.
Other: Individualized respiratory training group
Participants will be able to practice both inspiratory and expiratory respiratory muscle training in a single breathing cycle.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
8 weeks
Forced Vital Capacity
Time Frame: 8 weeks
The volume of air exhaled rapidly and forcefully following deep inspiration will be noted.
8 weeks
Peak Expiratory Flow
Time Frame: 8 weeks
Maximum inspiration followed by maximum exhalation maneuver will be measured and noted.
8 weeks
Respiratory Muscle Strength
Time Frame: 8 weeks
Inspiratory and expiratory respiratory muscle strength will be evaluated by intraoral pressure measurement method.
8 weeks
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.
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Minnesota Life with Heart Failure Questionnaire.
Time Frame: 8 weeks
Quality of life will be assessed using the Minnesota Life with Heart Failure Questionnaire.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biruni University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Istanbul Galata University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Mehmet Ezelsoy, MSc, Bilim University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 14, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 682201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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