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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inspiratory Muscle Training + Conventional Physiotherapy | Experimental | Participants receive the full conventional physiotherapy program plus Inspiratory Muscle Training (IMT) using a threshold device set initially at 40% of the individual's maximum inspiratory pressure (MIP). Training consists of 2 minutes of loading followed by 1 minute of rest, repeated 7 times (total 21 minutes), performed twice daily, 5 days per week, until surgery. |
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| Expiratory Muscle Training + Conventional Physiotherapy | Experimental | Participants receive the full conventional physiotherapy program plus Expiratory Muscle Training (EMT) using a threshold-based expiratory device set at 40% of maximum expiratory pressure (MEP). Training follows the same schedule as the IMT protocol (2 min loading / 1 min rest × 7 cycles), twice daily, 5 days per week, until surgery. |
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| Conventional Preoperative Physiotherapy (Control Group) | Experimental | Participants receive the standard preoperative physiotherapy program including diaphragmatic and thoracic breathing exercises, basal breathing techniques, and individualized walking training based on 80% of the 6-minute walk test distance. Three supervised sessions (one in-person, two via videoconference) are followed by daily home exercises until the surgery date. No respiratory muscle training device is used. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inspiratory Muscle Training | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pulmonary Complications (PPCs) | 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. | Average 2 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospital Stay | Total number of days from the date of surgery to hospital discharge. | Average 2 weeks. |
| Maximum Inspiratory Pressure (MIP) | Maximum inspiratory pressure measured using a standardized mouth pressure device (Cosmed Pony Fx) according to ATS/ERS respiratory muscle testing guidelines. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ESRA PEHLİVAN | Contact | +90 777 87 77 | fztesrakambur@yahoo.com | |
| Cahidenur KOÇAK | Contact | +90 777 87 77 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saglik Bilimleri Universitesi | Istanbul | Üsküdar | 34668 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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.
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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.
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| Expiratory Muscle Training | Other | 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. |
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| Conventional Physiotherapy | Other | 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. |
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| Baseline and preoperative reassessment. |
| Maximum Expiratory Pressure (MEP) | Maximum expiratory pressure measured using a standardized mouth pressure device (Cosmed Pony Fx) according to ATS/ERS respiratory muscle testing guidelines. | Baseline and preoperative reassessment. |
| Six-Minute Walk Distance (6MWD) | Distance covered during the standardized six-minute walk test performed according to ATS guidelines. | Baseline and preoperative reassessment. |
| Forced Expiratory Volume in 1 Second (FEV₁) | FEV₁ measured by spirometry (Cosmed Pony Fx) following ATS/ERS pulmonary function testing standards. | Baseline and preoperative reassessment. |
| Forced Vital Capacity (FVC) | FVC measured by spirometry (Cosmed Pony Fx) following ATS/ERS pulmonary function testing standards. | Baseline and preoperative reassessment. |
| Anxiety and Depression Evaluation | 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. | Baseline and preoperative reassessment. |
| Postoperative Surgical Complications | Surgical complications classified according to the Clavien-Dindo classification (Grades I-V). | Average 2 weeks. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |