Respiratory Muscle Training in Patients Undergoing Lung Cancer Surgery

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое 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.
• Другое 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.

Первичные конечные точки

• Postoperative Pulmonary Complications (PPCs) [Срок оценки: Average 2 weeks.]

Вторичные конечные точки (8)

• Length of Hospital Stay [Срок оценки: Average 2 weeks.]
• Maximum Inspiratory Pressure (MIP) [Срок оценки: Baseline and preoperative reassessment.]
• Maximum Expiratory Pressure (MEP) [Срок оценки: Baseline and preoperative reassessment.]
• Six-Minute Walk Distance (6MWD) [Срок оценки: Baseline and preoperative reassessment.]
• Forced Expiratory Volume in 1 Second (FEV₁) [Срок оценки: Baseline and preoperative reassessment.]
• Forced Vital Capacity (FVC) [Срок оценки: Baseline and preoperative reassessment.]
• Anxiety and Depression Evaluation [Срок оценки: Baseline and preoperative reassessment.]
• Postoperative Surgical Complications [Срок оценки: Average 2 weeks.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Turkey (Türkiye) · 1 центр

• Saglik Bilimleri Universitesi — Istanbul

Идентификаторы

NCT: NCT07499986 · RMT_Preop 1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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