Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00363428
Status:
COMPLETED
Last Update Posted:
2017-07-19
First Post:
2006-08-10
Brief Title:
Lung Rehabilitation in Treating Patients With Chronic Obstructive Pulmonary Disease Who Are Undergoing Surgery for Lung Cancer
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A Randomized Trial of Pulmonary Rehabilitation in Patients With Moderate to Severe COPD Who Require Lung Resection for Lung Cancer
Status:
COMPLETED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 ie 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
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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MC0825 | OTHER | Mayo Clinic Cancer Center | httpsreporternihgovquickSearchK23CA106544 |
| P30CA047904 | NIH | None | None |
| K23CA106544 | NIH | None | None |
| 08-007135 | OTHER | None | None |
| NCI-2009-01148 | REGISTRY | None | None |