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

Not Applicable

Completed

• Conditions: Pulmonary Complications; Lung Cancer; Perioperative/Postoperative Complications; Tobacco Use Disorder
• Interventions: Behavioral: exercise intervention; Behavioral: smoking cessation intervention; Other: counseling intervention; Other: educational intervention; Procedure: conventional surgery; Procedure: pulmonary complications management/prevention

• Registration Number: NCT00363428
• Lead Sponsor: Mayo Clinic

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.

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.

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-08-10
• Study First Submitted QC: 2006-08-10
• Study First Posted: 2006-08-15
• Primary Completion: 2012-11-01
• Study Completion: 2012-11-01
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-17
• Last Update Posted: 2017-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle intervention	exercise intervention	-
Lifestyle intervention	educational intervention	-
Lifestyle intervention	conventional surgery	-
Lifestyle intervention	pulmonary complications management/prevention	-
Control	educational intervention	Receive standard care and educational material on exercise and lifestyle choices of well-being
Control	pulmonary complications management/prevention	Receive standard care and educational material on exercise and lifestyle choices of well-being
Control	counseling intervention	Receive standard care and educational material on exercise and lifestyle choices of well-being
Lifestyle intervention	counseling intervention	-
Control	exercise intervention	Receive standard care and educational material on exercise and lifestyle choices of well-being
Control	conventional surgery	Receive standard care and educational material on exercise and lifestyle choices of well-being
Lifestyle intervention	smoking cessation intervention	-
Control	smoking cessation intervention	Receive standard care and educational material on exercise and lifestyle choices of well-being

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States