Respiratory Muscle Training in Patients Undergoing Lung Cancer Surgery

Sponsor
Saglik Bilimleri Universitesi
Study ID
NCT07499986
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

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.
  • 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.
  • 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.

Study Details

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.

Key Dates

First listed
Mar 30, 2026
Start date
Dec 30, 2026
Status verified
Mar 2026
Primary completion
Dec 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Postoperative Pulmonary Complications (PPCs) [ Time Frame: Average 2 weeks. ]

Central Contacts

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