Pulmonary Function, Muscle Strength, and Functional Capacity in Minimally Invasive Cardiac Surgery

September 11, 2025 updated by: Zehra Can Karahan

Evaluation of Pulmonary Function, Respiratory Muscle Strength, Peripheral Muscle Strength and Functional Capacity in Individuals Undergoing Minimally Invasive Cardiac Surgery

The goal of this observational study is to evaluate pulmonary function, respiratory muscle strength, peripheral muscle strength, and functional capacity in adult patients undergoing either minimally invasive cardiac surgery (via mini-thoracotomy) or conventional sternotomy for coronary artery bypass grafting (CABG) at Gülhane Training and Research Hospital.The main questions it aims to answer are:

Does minimally invasive cardiac surgery preserve pulmonary function better than conventional sternotomy? Does minimally invasive cardiac surgery result in less respiratory and peripheral muscle weakness compared to conventional sternotomy? Researchers will compare patients undergoing minimally invasive surgery with those undergoing conventional sternotomy to determine differences in pulmonary function, respiratory muscle strength, peripheral muscle strength, and functional capacity.

Participants will:

Undergo preoperative and postoperative (day 4) assessments including spirometry, inspiratory/expiratory mouth pressure measurements, and peripheral muscle strength testing (handgrip, shoulder flexion/abduction, hip flexion, knee extension).

Perform functional capacity tests (30-second sit-to-stand test, 6-minute walk test).

Complete questionnaires assessing pain (McGill Pain Questionnaire) and fear of movement (Tampa Scale of Kinesiophobia).

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

Coronary artery bypass grafting (CABG) is one of the most commonly performed surgical procedures for patients with complex coronary artery disease. While the standard approach is through median sternotomy, minimally invasive cardiac surgery performed via mini-thoracotomy has gained popularity due to potential benefits such as smaller incisions, reduced surgical trauma, lower risk of sternal complications, shorter hospital stays, and faster mobilization. However, its effects on pulmonary function, respiratory muscle strength, peripheral muscle strength, and functional capacity have not been sufficiently clarified.

Postoperative pulmonary complications are a significant concern in cardiac surgery. Procedures involving cardiopulmonary bypass may result in atelectasis, pneumonia, pleural effusion, phrenic nerve injury, and diaphragm dysfunction. These complications can impair respiratory mechanics, delay rehabilitation, and increase morbidity and mortality. Therefore, identifying surgical approaches that better preserve pulmonary and muscular function is of great clinical importance.

This observational study will prospectively evaluate adult patients undergoing CABG at Gülhane Training and Research Hospital, comparing two groups: those receiving minimally invasive cardiac surgery via mini-thoracotomy and those undergoing conventional sternotomy. The primary outcomes are changes in pulmonary function parameters measured by spirometry (FVC, FEV1, PEF) from baseline to postoperative day 4. Secondary outcomes include respiratory muscle strength (MIP, MEP), peripheral muscle strength (handgrip, shoulder flexion/abduction, hip flexion, knee extension), functional capacity (30-second sit-to-stand test, 6-minute walk test), pain intensity (McGill Pain Questionnaire), and fear of movement (Tampa Scale of Kinesiophobia).

All assessments will be performed twice: before surgery (preoperative baseline) and on postoperative day 4. This time frame was chosen to capture early postoperative functional changes, which may influence short-term recovery and rehabilitation strategies. By comparing the two surgical techniques, this study aims to determine whether minimally invasive cardiac surgery provides better preservation of pulmonary and muscular function, ultimately supporting improved patient-centered outcomes and guiding clinical decision-making in surgical practice.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

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

Study Locations

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult patients (18-80 years) scheduled for elective coronary artery bypass grafting at Gülhane Training and Research Hospital, either via minimally invasive mini-thoracotomy or conventional sternotomy approach.

Description

Inclusion Criteria:

  • Adults aged 18-80 years
  • Scheduled for elective cardiac surgery via either minimally invasive approach (mini-thoracotomy) or conventional sternotomy at Gülhane Training and Research Hospital
  • Able to provide written informed consent

Exclusion Criteria:

  • Previous history of cardiac surgery
  • Presence of orthopedic or neurological disorders affecting mobility or muscle strength
  • Postoperative cerebrovascular event
  • Requirement for mechanical ventilation > 24 hours postoperatively
  • Intensive care unit stay > 48 hours

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pulmonary Function - Forced Vital Capacity (FVC)
Time Frame: Baseline [preoperative] and postoperative day 4)
Forced Vital Capacity measured by spirometry. Results will be reported in liters (L).
Baseline [preoperative] and postoperative day 4)
Change in Pulmonary Function - Forced Expiratory Volume in 1 second (FEV1)
Time Frame: Baseline to postoperative day 4
Forced Expiratory Volume in 1 second measured by spirometry. Results will be reported in liters (L).
Baseline to postoperative day 4
Change in Respiratory Muscle Strength - Maximal Inspiratory Pressure (MIP)
Time Frame: Baseline [preoperative] and postoperative day 4
Inspiratory muscle strength measured with mouth pressure device. Results will be reported in cmH₂O.
Baseline [preoperative] and postoperative day 4
Change in Respiratory Muscle Strength - Maximal Expiratory Pressure (MEP)
Time Frame: Baseline [preoperative] and postoperative day 4
Expiratory muscle strength measured with mouth pressure device. Results will be reported in cmH₂O.
Baseline [preoperative] and postoperative day 4
Change in Handgrip Strength
Time Frame: Baseline to postoperative day 4
Handgrip strength measured with handheld dynamometer. Results will be reported in kilograms (kg).
Baseline to postoperative day 4
Change in Knee Extension Strength
Time Frame: Baseline to postoperative day 4
Knee extension strength measured with handheld dynamometer. Results will be reported in kilograms (kg).
Baseline to postoperative day 4
Change in Functional Capacity - 30-Second Sit-to-Stand Test
Time Frame: Baseline to postoperative day 4
Number of repetitions performed during the 30-second sit-to-stand test. Results will be reported as number of repetitions.
Baseline to postoperative day 4
Change in Functional Capacity - 6-Minute Walk Distance
Time Frame: Baseline to postoperative day 4
Distance covered during the 6-minute walk test. Results will be reported in meters (m).
Baseline to postoperative day 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Intensity - McGill Pain Questionnaire
Time Frame: Baseline and postoperative day 4
Pain intensity assessed with the McGill Pain Questionnaire. Results will be reported as score values (units on a scale). Minimum score: 0 (no pain) Maximum score: 78 (maximum pain intensity) Higher scores indicate worse pain.
Baseline and postoperative day 4
Change in Kinesiophobia - Tampa Scale of Kinesiophobia (TSK-17)
Time Frame: Baseline and postoperative day 4
Fear of movement assessed with the Tampa Scale of Kinesiophobia (TSK-17). Results will be reported as score values ranging from 17 to 68 (units on a scale).Higher scores indicate greater fear of movement (worse outcome).
Baseline and postoperative day 4

Collaborators and Investigators

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

Sponsor

Zehra Can Karahan

Investigators

  • Study Director: Zehra Can Karahan, PHD, Atılım 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)

May 1, 2024

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

August 18, 2025

First Submitted That Met QC Criteria

September 11, 2025

First Posted (Estimated)

September 15, 2025

Study Record Updates

Last Update Posted (Estimated)

September 15, 2025

Last Update Submitted That Met QC Criteria

September 11, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3dcd45b218264a9a

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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