A Randomized Trial of Pulmonary Rehabilitation in Patients With Moderate to Severe COPD Who Require Lung Resection for Lung Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Length of stay in hospital and functional status measured at 12 weeks post-operatively
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 120 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •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.
- •PATIENT CHARACTERISTICS:
- •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
- •PRIOR CONCURRENT THERAPY:
- •Not specified
Exclusion Criteria
- Not provided
Arms & Interventions
Control
Receive standard care and educational material on exercise and lifestyle choices of well-being
Intervention: exercise intervention (Behavioral)
Control
Receive standard care and educational material on exercise and lifestyle choices of well-being
Intervention: smoking cessation intervention (Behavioral)
Control
Receive standard care and educational material on exercise and lifestyle choices of well-being
Intervention: counseling intervention (Other)
Control
Receive standard care and educational material on exercise and lifestyle choices of well-being
Intervention: educational intervention (Other)
Control
Receive standard care and educational material on exercise and lifestyle choices of well-being
Intervention: conventional surgery (Procedure)
Control
Receive standard care and educational material on exercise and lifestyle choices of well-being
Intervention: pulmonary complications management/prevention (Procedure)
Lifestyle intervention
Intervention: exercise intervention (Behavioral)
Lifestyle intervention
Intervention: smoking cessation intervention (Behavioral)
Lifestyle intervention
Intervention: counseling intervention (Other)
Lifestyle intervention
Intervention: educational intervention (Other)
Lifestyle intervention
Intervention: conventional surgery (Procedure)
Lifestyle intervention
Intervention: pulmonary complications management/prevention (Procedure)
Outcomes
Primary Outcomes
Length of stay in hospital and functional status measured at 12 weeks post-operatively
Time Frame: 12 weeks
Secondary Outcomes
- Hospital re-admission(12 months)
- Oxygen requirement(12 months)
- Post-operative pulmonary function(12 months)
- Respiratory care interventions(12 months)
- Number and percentage of patients with postoperative complications (defined as pneumonia, mechanical ventilation of more than 2 days, or atelectasis requiring a bronchoscopy)(12 months)
- Measured physical activity at 6 months(12 months)