NCT00363428

Lung Rehabilitation in Treating Patients With Chronic Obstructive Pulmonary Disease Who Are Undergoing Surgery for Lung Cancer

A Randomized Trial of Pulmonary Rehabilitation in Patients With Moderate to Severe COPD Who Require Lung Resection for Lung Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 40 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Exercise may help improve lung function and lessen complications of surgery in patients with chronic obstructive pulmonary disease who are undergoing surgery for lung cancer. It is not yet known whether lung rehabilitation is more effective than standard therapy in improving lung function in patients with chronic obstructive pulmonary disease who are undergoing surgery for lung cancer. PURPOSE: This randomized clinical trial is studying lung rehabilitation to see how well it works compared to standard therapy in treating patients with chronic obstructive pulmonary disease who are undergoing surgery for lung cancer.

Detailed description

OBJECTIVES: Primary * Compare the impact of preoperative pulmonary rehabilitation (including upper and lower extremity resistance training) vs usual care in patients with lung cancer and moderate to severe chronic obstructive pulmonary disease who require lung resection for lung cancer. * Compare the impact of this study intervention vs usual care on functional status after surgery. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 intervention arms. * Arm I: Patients undergo pulmonary rehabilitation (including daily upper and lower extremity resistance training, education, and smoking cessation counseling) twice a day for 5 days prior to surgical resection. Beginning 2-3days after surgery, patients undergo pulmonary rehabilitation once a day until discharge from the hospital. * Arm II: Patients receive usual care (education and smoking cessation counseling alone) twice a day for 5 days prior to surgical resection. Following surgery, patients will receive usual care once a day until discharge from the hospital. Days of hospitalization, ICU admissions, postoperative complications (i.e., pneumonia, mechanical ventilation \> 48 hours, or atelectasis requiring bronchoscopy) and spirometry and imaging studies will be evaluated after surgery. After completion of study intervention, patients are followed at 4-6 weeks, at 12 weeks, and at 6 months. PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.

Conditions

• Lung Cancer
• Perioperative/Postoperative Complications
• Pulmonary Complications
• Tobacco Use Disorder

Interventions

Type	Name	Description
BEHAVIORAL	exercise intervention	life style
BEHAVIORAL	smoking cessation intervention	Life style
OTHER	counseling intervention	life style
OTHER	educational intervention	life style
PROCEDURE	conventional surgery	life style
PROCEDURE	pulmonary complications management/prevention	life style

Timeline

• Start date: 2006-08-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2006-08-15
• Last updated: 2017-07-19

Locations

1 site across 1 country: United States