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OpenTrials
Completed

NCT Number: NCT00363428

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise Intervention

Behavioral

life style

Smoking Cessation Intervention

Behavioral

Life style

counseling intervention

Other

life style

Educational Intervention

Other

life style

conventional surgery

Procedure

life style

pulmonary complications management/prevention

Procedure

life style

Primary outcomes

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

    Time frame: 12 weeks

Secondary outcomes

  1. Hospital re-admission

    Time frame: 12 months

  2. Oxygen requirement

    Time frame: 12 months

  3. Post-operative pulmonary function

    Time frame: 12 months

  4. Respiratory care interventions

    Time frame: 12 months

  5. Number and percentage of patients with postoperative complications (defined as pneumonia, mechanical ventilation of more than 2 days, or atelectasis requiring a bronchoscopy)

    Time frame: 12 months

  6. Measured physical activity at 6 months

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
Aug 15, 2006
Registry last updated
Jul 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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