A Randomized Trial of Pulmonary Rehabilitation in Patients With Moderate to Severe COPD Who Require Lung Resection for Lung Cancer
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.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Length of stay in hospital and functional status measured at 12 weeks post-operatively
12 weeks
No
Roberto P. Benzo, MD, MS
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000491312
NCT00363428
August 2006
Name | Location |
---|---|
Mayo Clinic | Rochester, Minnesota 55905 |