Customizable Respiratory Exercise Device in Individuals Who Have Undergone Cardiac Surgery

NCT06258681 | Recruiting

• 1 other identifier: 682201
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Coronary Artery Disease

Keywords

cardiac surgery; respiratory muscle training; aerobic exercise

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (1)

• Minnesota Life with Heart Failure Questionnaire.

  8 weeks

Study Arms (2)

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.

Other: Incentive spirometer

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.

Other: Individualized respiratory training group

Interventions

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.

Incentive spirometry group

Individualized respiratory training group OTHER

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

Individualized respiratory training group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biruni University: lead
• Istanbul Galata University: collaborator

Study Sites (1)

Istanbul Florence Nightingale Hospital

Istanbul, Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Mehmet Ezelsoy, MSc

  Bilim University

  STUDY DIRECTOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The assessor will be blind to the group allocation and participants will be blind to the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: This is a two-arm controlled single blind trial.

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 14, 2024
• Study Start: February 28, 2024
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)