Respiratory Muscle Training in Patients Undergoing Lung Cancer Surgery

NCT07499986 | Not Yet Recruiting

• 1 other identifier: RMT_Preop 1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Length of Hospital Stay

  Average 2 weeks.

• Maximum Inspiratory Pressure (MIP)

  Baseline and preoperative reassessment.

• Maximum Expiratory Pressure (MEP)

  Baseline and preoperative reassessment.

• Six-Minute Walk Distance (6MWD)

  Baseline and preoperative reassessment.

• Forced Expiratory Volume in 1 Second (FEV₁)

  Baseline and preoperative reassessment.

Study Arms (3)

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.

Other: Inspiratory Muscle Training; Other: Conventional Physiotherapy

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.

Other: Expiratory Muscle Training; Other: Conventional Physiotherapy

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.

Other: Conventional Physiotherapy

Interventions

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.

Also known as: IMT

Inspiratory Muscle Training + Conventional Physiotherapy

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.

Also known as: EMT

Expiratory Muscle Training + Conventional Physiotherapy

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.

Conventional Preoperative Physiotherapy (Control Group); Expiratory Muscle Training + Conventional Physiotherapy; Inspiratory Muscle Training + Conventional Physiotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Saglik Bilimleri Universitesi

Istanbul, Üsküdar, 34668, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

ESRA PEHLİVAN

CONTACT

+90 777 87 77; fztesrakambur@yahoo.com

Cahidenur KOÇAK

CONTACT

+90 777 87 77

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: March 30, 2026
• Study Start (Estimated): December 30, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

TU (1)