Respiratory Muscle Training in Patients Undergoing Lung Cancer Surgery

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Other: Inspiratory Muscle Training; Other: Conventional Physiotherapy; Other: Expiratory Muscle Training

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ESRA PEHLİVAN; Phone Number: +90 777 87 77; Email: fztesrakambur@yahoo.com
• Study Contact Backup: Name: Cahidenur KOÇAK; Phone Number: +90 777 87 77

Study Locations

• Turkey (Türkiye)
  • Üsküdar
    • Istanbul, Üsküdar, Turkey (Türkiye), 34668
      • Saglik Bilimleri Universitesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Inspiratory Muscle Training + Conventional Physiotherapy; 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.	Other: Inspiratory 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.; Other Names: IMT; Other: Conventional 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.
Experimental: Expiratory Muscle Training + Conventional Physiotherapy; 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.	Other: Conventional 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.; Other: Expiratory Muscle Training; 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.; Other Names: EMT
Experimental: Conventional Preoperative Physiotherapy (Control Group); 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.	Other: Conventional 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.	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.

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi

Study record dates

Study Major Dates

• Study Start (Estimated): December 30, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: November 27, 2025
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: RMT_Preop 1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No