NCT07172529

Brief 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 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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2025

Completed
28 days until next milestone

First Posted

Study publicly available on registry

September 15, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

1.5 years

First QC Date

August 18, 2025

Last Update Submit

September 11, 2025

Conditions

Keywords

cardiac surgerymuscle weaknesspulmonary functionkinesiophobiafunctional capacity

Outcome Measures

Primary Outcomes (8)

  • Change in Pulmonary Function - Forced Vital Capacity (FVC)

    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)

    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)

    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)

    Expiratory muscle strength measured with mouth pressure device. Results will be reported in cmH₂O.

    Baseline [preoperative] and postoperative day 4

  • Change in Handgrip Strength

    Handgrip strength measured with handheld dynamometer. Results will be reported in kilograms (kg).

    Baseline to postoperative day 4

  • Change in Knee Extension Strength

    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

    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

    Distance covered during the 6-minute walk test. Results will be reported in meters (m).

    Baseline to postoperative day 4

Secondary Outcomes (2)

  • Change in Pain Intensity - McGill Pain Questionnaire

    Baseline and postoperative day 4

  • Change in Kinesiophobia - Tampa Scale of Kinesiophobia (TSK-17)

    Baseline and postoperative day 4

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atilim University

Ankara, 06830, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Muscle WeaknessKinesiophobia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsPhobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Zehra Can Karahan, PHD

    Atılım University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

August 18, 2025

First Posted

September 15, 2025

Study Start

May 1, 2024

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

September 15, 2025

Record last verified: 2025-09

Locations