Cardiac SurgeryNCT07172529
Pulmonary Function, Muscle Strength, and Functional Capacity in Minimally Invasive Cardiac Surgery
An observational study of Cardiac Surgery and Muscle Weakness | Patient, run by Zehra Can Karahan at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Surgery, Muscle Weakness | Patient, Pulmonary Function
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2024to Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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).
Read the 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.
- Keywords
- cardiac surgery, muscle weakness, pulmonary function, kinesiophobia, functional capacity
- Medical subject headings
- Muscle Weakness, Kinesiophobia
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pulmonary Function - Forced Vital Capacity (FVC)
Forced Vital Capacity measured by spirometry. Results will be reported in liters (L).
Measured: Baseline [preoperative] and postoperative day 4)
Change in Pulmonary Function - Forced Expiratory Volume in 1 second (FEV1)
Forced Expiratory Volume in 1 second measured by spirometry. Results will be reported in liters (L).
Measured: Baseline to postoperative day 4
Change in Respiratory Muscle Strength - Maximal Inspiratory Pressure (MIP)
Inspiratory muscle strength measured with mouth pressure device. Results will be reported in cmH₂O.
Measured: Baseline [preoperative] and postoperative day 4
Change in Respiratory Muscle Strength - Maximal Expiratory Pressure (MEP)
Expiratory muscle strength measured with mouth pressure device. Results will be reported in cmH₂O.
Measured: Baseline [preoperative] and postoperative day 4
Change in Handgrip Strength
Handgrip strength measured with handheld dynamometer. Results will be reported in kilograms (kg).
Measured: Baseline to postoperative day 4
Change in Knee Extension Strength
Knee extension strength measured with handheld dynamometer. Results will be reported in kilograms (kg).
Measured: Baseline to postoperative day 4
Change in Functional Capacity - 30-Second Sit-to-Stand Test
Number of repetitions performed during the 30-second sit-to-stand test. Results will be reported as number of repetitions.
Measured: Baseline to postoperative day 4
Change in Functional Capacity - 6-Minute Walk Distance
Distance covered during the 6-minute walk test. Results will be reported in meters (m).
Measured: Baseline to postoperative day 4
Secondary outcomes (2)
Change in Pain Intensity - McGill Pain Questionnaire
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.
Measured: Baseline and postoperative day 4
Change in Kinesiophobia - Tampa Scale of Kinesiophobia (TSK-17)
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).
Measured: Baseline and postoperative day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start1 May 2024
- Primary completion1 Nov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zehra Can Karahan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zehra Can Karahan, Atılım University
- Investigators
- Zehra Can Karahan, PHD, Study director, Atılım University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172529
- Sponsor's protocol ID
- 3dcd45b218264a9a
- Status last verified
- Sep 2025
- First submitted
- 18 Aug 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Can Karahan Z, Ozdem T. Less fear, better function: the impact of minimally invasive cardiac surgery on kinesiophobia and functional capacity compared to median sternotomy. Front Med (Lausanne). 2026 May 14;13:1829842. doi: 10.3389/fmed.2026.1829842. eCollection 2026.
PubMed 42221065
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pulmonary Function, Respiratory Muscle Strength, Peripheral Muscle Strength and Functional Capacity in Individuals Undergoing Minimally Invasive Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07172529
- Acronym / sponsor ID
- 3dcd45b218264a9a
- Keywords
- cardiac surgery, muscle weakness, pulmonary function, kinesiophobia, functional capacity
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Zehra Can KarahanUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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).
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.
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.
Change in Handgrip Strength
Time frame: Baseline to postoperative day 4
Handgrip strength measured with handheld dynamometer. Results will be reported in kilograms (kg).
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).
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.
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).
2 secondary outcomes
Change in Pain Intensity - McGill Pain Questionnaire
Time frame: Baseline and postoperative day 4
Change in Kinesiophobia - Tampa Scale of Kinesiophobia (TSK-17)
Time frame: Baseline and postoperative day 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Derived from this study: PubMed 42221065Can Karahan Z, Ozdem T. Less fear, better function: the impact of minimally invasive cardiac surgery on kinesiophobia and functional capacity compared to median sternotomy. Front Med (Lausanne). 2026 May 14;13:1829842. doi: 10.3389/fmed.2026.1829842. eCollection 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zehra Can Karahan, PHD study director
Atılım University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgery and Muscle Weakness | Patient, run by Zehra Can Karahan at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pulmonary Function - Forced Vital Capacity (FVC) (time frame: Baseline [preoperative] and postoperative day 4)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07172529, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.