Trials / Recruiting

RecruitingNCT04067830

Respiratory Muscle Training Before Surgery in Preventing Lung Complications in Patients With Stage I-IIIB Lung Cancer

Preoperative Respiratory Muscle Training to Prevent Postoperative Pulmonary Complications in Patients Undergoing Resection for Lung Cancer

Status: Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 220 (estimated)

Sponsor: Roswell Park Cancer Institute · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This phase II trial studies how well respiratory muscle training before surgery works in preventing lung complications after surgery in patients with stage I-IIIB lung cancer. Patients with lung cancer who choose to undergo surgical resection often have complications after surgery such as pneumonia, unplanned intubations, difficulty breathing and reduced physical functioning, and increased medical costs and a reduced quality of life. Improving pre-surgical pulmonary health through respiratory muscle training may improve respiratory muscle strength, response to surgery, and quality of life after surgery in patients with lung cancer.

Detailed description

PRIMARY OBJECTIVES: I. Assess the impact of a short-duration respiratory muscle training (RMT) program on respiratory muscle strength in patients undergoing resection for lung cancer. SECONDARY OBJECTIVES: I. Compare the extent of diaphragm atrophy and catabolic/anabolic pathway activation between RMT responders and non-responders evaluated for gene expression and candidate and candidate causative protein levels. II. Determine the effect of the short-duration RMT program on health related quality-of-life measures. III. Assess the impact of the short-duration RMT program on postoperative outcomes. EXPLORATORY OBJECTIVES: I. Determine the financial sustainability of a transitional home-based prehabilitation program targeting respiratory muscle weakness prior to lung resection. II. Analysis of molecular markers to correlate with patient outcome and potentially differentiate responders from non-responders. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I (USUAL CARE): Patients receive usual care consisting of physical therapy once weekly, receiving pre-surgical information, instruction on the use of a spirometer device, and wearing a Fitbit to track activity. Patients then undergo video-assisted thoracic surgery or laparoscopic surgery. Patients continue to track activity using the Fitbit for 3 months post-surgery. ARM II (RMT + USUAL CARE): Patients use a power lung device to complete 3 sets of 15 RMT exercises over 30 minutes 6 days per week over 2-4 weeks for a minimum of 12 sessions prior to surgery. Patients also receive usual care consisting of physical therapy once weekly, receiving pre-surgical information, instruction on the use of a spirometer device, and wearing a Fitbit to track activity. Patients then undergo video-assisted thoracic surgery or laparoscopic surgery. Patients continue to track activity using the Fitbit for 3 months post-surgery. After completion of study, patients are followed up at 1, 3, 6, and 12 months.

Conditions

Interventions

Type	Name	Description
OTHER	Best Practice	Receive usual care
PROCEDURE	Laparoscopic Surgery	Undergo laparoscopic surgery
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
DEVICE	Respiratory Muscle Training Device	Use power lung device to complete RMT
PROCEDURE	Video-Assisted Thoracic Surgery	Undergo video-assisted thoracic surgery

Timeline

Start date: 2019-03-20
Primary completion: 2027-03-22
Completion: 2027-03-22
First posted: 2019-08-28
Last updated: 2025-09-05

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated device study

Source: ClinicalTrials.gov record NCT04067830. Inclusion in this directory is not an endorsement.