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

40 Years
Open (Enrolling)
Lung Cancer, Perioperative/Postoperative Complications, Pulmonary Complications, Tobacco Use Disorder

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Trial Information

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



- 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

- Compare the impact of this study intervention vs usual care on functional status after

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.

Inclusion Criteria


- Diagnosis of lung cancer

- Scheduled to undergo any thoracotomy for lung cancer resection (including wedge) or
VATS lobectomy or pneumonectomy for lung resection

- Diagnosis of COPD, meeting the following criteria:

- FEV_1/FVC < 0.71

- Smoking history ≥ 10 pack/years

- Presence of moderate to severe lung disease, meeting 1 of the following:

- FEV_1 ≤ 60% predicted*

- FEV_1< 80% predicted AND significant shortness of breath defined by a score of 2
or higher in the Medical Research Council Dyspnea Score NOTE: *Patients with an
FEV1 < 60% predicted (most severe) and scheduled to undergo VATS segmentectomy
or wedge resection will also be included.


- Able to physically utilize exercise equipment as part of rehabilitation program

- No poor motivation or likely not to participate fully in PR program

- No recent history (within the past 3 months) of a clinically-significant myocardial
infarction, unstable angina, serious cardiac arrhythmia, or other serious medical
condition which the attending physician performing the preoperative evaluation deems
incompatible with participation in the study


- Not specified

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Length of stay in hospital and functional status measured at 12 weeks post-operatively

Outcome Time Frame:

12 weeks

Safety Issue:


Principal Investigator

Roberto P. Benzo, MD, MS

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

August 2006

Completion Date:

Related Keywords:

  • Lung Cancer
  • Perioperative/Postoperative Complications
  • Pulmonary Complications
  • Tobacco Use Disorder
  • pulmonary complications
  • perioperative/postoperative complications
  • tobacco use disorder
  • non-small cell lung cancer
  • small cell lung cancer
  • Lung Diseases
  • Pulmonary Disease, Chronic Obstructive
  • Lung Neoplasms
  • Postoperative Complications
  • Tobacco Use Disorder
  • Lung Diseases, Obstructive



Mayo Clinic Rochester, Minnesota  55905