Lung Cancer
Conditions
Brief summary
This randomized, controlled, double-blind clinical trial aims to investigate the effectiveness of preoperative inspiratory muscle training (IMT) and expiratory muscle training (EMT) in patients scheduled for lung cancer surgery. Respiratory muscle dysfunction contributes to postoperative pulmonary complications (PPCs), prolonged hospitalization, and reduced functional recovery. Although IMT has been evaluated in several studies, the evidence is limited and heterogeneous, and the effectiveness of EMT in this population has never been studied. This study will compare conventional preoperative physiotherapy alone with physiotherapy combined with IMT or EMT to determine their impact on postoperative clinical outcomes, respiratory muscle function, and exercise capacity.
Detailed description
Lung cancer surgery is frequently associated with postoperative pulmonary complications, which negatively impact recovery, hospital length of stay, and postoperative quality of life. Preoperative physiotherapy has been shown to improve clinical outcomes; however, the optimal content of such programs remains unclear. Inspiratory muscle training has been associated with improvements in maximum inspiratory pressure (MIP), exercise capacity, and potentially reduced PPC rates, though findings are inconsistent. In contrast, no study has evaluated expiratory muscle training-despite its potential benefits in enhancing cough effectiveness, secretion clearance, and thoracic stability after surgery. This trial is designed to fill this knowledge gap by systematically comparing IMT and EMT within a structured preoperative physiotherapy program. All groups will receive standard preoperative education, breathing exercises, and walking training. Participants randomized to the IMT or EMT groups will additionally undergo daily training using threshold-based devices at 40% of MIP or MEP, respectively, with intensity progression based on the Borg scale.
Interventions
OTHERInspiratory Muscle Training
Inspiratory muscle training is performed using a threshold device (PowerBreathe Classic) beginning at 40% of the individual's maximum inspiratory pressure (MIP). Training consists of 2 minutes of loading followed by 1 minute of rest, repeated for 7 cycles (total 21 minutes), performed twice daily, 5 days per week, until surgery. Load progression is adjusted to maintain a Borg dyspnea score of approximately 4/10. IMT is provided in addition to the full conventional physiotherapy program.
Expiratory muscle training is performed using a threshold expiratory device (PowerBreathe Expir Medic) starting at 40% of the individual's maximum expiratory pressure (MEP). The protocol follows the same structure as IMT: 2 minutes loading / 1 minute rest for 7 cycles (21 minutes), twice daily, 5 days per week, until surgery, with load progression based on a Borg score of 4/10. EMT is provided in addition to the full conventional physiotherapy program.
OTHERConventional Physiotherapy
The conventional physiotherapy program includes diaphragmatic, basal, and thoracic breathing exercises, pursed-lip breathing, and walking training prescribed at 80% of the distance achieved during the six-minute walk test. Participants receive one in-person supervised session followed by two videoconference reinforcement sessions and then continue daily home exercises until the day of surgery.
Sponsors
Saglik Bilimleri Universitesi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
This study uses a double-blind design. Participants are blinded to group allocation, as all groups receive a physiotherapy program and a handheld respiratory device that appears similar in structure. The outcome assessors conducting pre- and postoperative evaluations (spirometry, respiratory muscle strength, 6MWT, and postoperative complication assessment) are also blinded to group assignment. Treating physiotherapists delivering the IMT/EMT interventions are not blinded due to the nature of the training protocols; however, they are not involved in outcome assessment.
Intervention model description
This study uses a three-arm, parallel-group, randomized controlled design to compare the effects of conventional preoperative physiotherapy alone with physiotherapy combined with inspiratory muscle training (IMT) or expiratory muscle training (EMT). Participants are randomized in equal allocation (1:1:1) using a block randomization sequence with concealed allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of lung cancer staged IA to IIIB based on clinical staging * Planned to undergo surgery via thoracotomy or videothoracoscopy (VATS) * Having a smartphone and being capable of performing video call
Exclusion criteria
* Presence of a cardiac disease that affects quality of life (ASA II or better is required) * Presence of severe cognitive problems or psychiatric disorders * Presence of physical limitations (e.g., visual or hearing impairment, orthopedic problems) * If the lung cancer diagnosis is not confirmed after frozen section or wedge resection, the patient will be removed from the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pulmonary Complications (PPCs) | Average 2 weeks. | Presence of postoperative pulmonary complications assessed using the Melbourne Group Scale (8 diagnostic criteria including fever, leukocytosis, radiological infiltrates, oxygen desaturation, increased secretions, abnormal lung auscultation, respiratory deterioration, and evidence of infection). A PPC is recorded if ≥4 criteria are met. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay | Average 2 weeks. | Total number of days from the date of surgery to hospital discharge. |
| Maximum Inspiratory Pressure (MIP) | Baseline and preoperative reassessment. | Maximum inspiratory pressure measured using a standardized mouth pressure device (Cosmed Pony Fx) according to ATS/ERS respiratory muscle testing guidelines. |
| Maximum Expiratory Pressure (MEP) | Baseline and preoperative reassessment. | Maximum expiratory pressure measured using a standardized mouth pressure device (Cosmed Pony Fx) according to ATS/ERS respiratory muscle testing guidelines. |
| Six-Minute Walk Distance (6MWD) | Baseline and preoperative reassessment. | Distance covered during the standardized six-minute walk test performed according to ATS guidelines. |
| Forced Expiratory Volume in 1 Second (FEV₁) | Baseline and preoperative reassessment. | FEV₁ measured by spirometry (Cosmed Pony Fx) following ATS/ERS pulmonary function testing standards. |
| Forced Vital Capacity (FVC) | Baseline and preoperative reassessment. | FVC measured by spirometry (Cosmed Pony Fx) following ATS/ERS pulmonary function testing standards. |
| Anxiety and Depression Evaluation | Baseline and preoperative reassessment. | Anxiety and depression levels measured using the Hospital Anxiety and Depression Scale.The Hospital Anxiety and Depression Scale (HADS) includes two subscales-anxiety (HADS-A) and depression (HADS-D)-each scored from 0 to 21. Higher scores indicate greater symptom severity. Scores of 0-7 are considered within the normal range, 8-10 indicate borderline or possible anxiety/depression, and scores of 11 or above reflect clinically significant symptoms. |
| Postoperative Surgical Complications | Average 2 weeks. | Surgical complications classified according to the Clavien-Dindo classification (Grades I-V). |
Countries
Turkey (Türkiye)
Contacts
CONTACTESRA PEHLİVAN
CONTACTCahidenur KOÇAK
Outcome results
None listed