Lung Rehabilitation in Treating Patients With Chronic Obstructive Pulmonary Disease Who Are Undergoing Surgery for Lung Cancer
NCT ID: NCT00363428
Last Updated: 2017-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
19 participants
INTERVENTIONAL
2006-08-31
2012-11-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pulmonary Rehabilitation Before Lung Cancer Resection
NCT01682850
Effect of Pulmonary Rehabilitation in Lung Cancer Survivors
NCT01246297
Pulmonary Rehabilitation Before Lung Cancer Resection
NCT02887521
Effectiveness of a Preoperative Pulmonary Rehabilitation Program in Patients Awaiting Lung Resection
NCT01963923
S0229, Pulmonary Rehabilitation Education w/wo Exercise Training in Improving Physical Function in Patients Who Are Undergoing Chemo & RT for Locally Advanced Lung Cancer
NCT00090961
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control
Receive standard care and educational material on exercise and lifestyle choices of well-being
exercise intervention
life style
smoking cessation intervention
Life style
counseling intervention
life style
educational intervention
life style
conventional surgery
life style
pulmonary complications management/prevention
life style
Lifestyle intervention
exercise intervention
life style
smoking cessation intervention
Life style
counseling intervention
life style
educational intervention
life style
conventional surgery
life style
pulmonary complications management/prevention
life style
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
exercise intervention
life style
smoking cessation intervention
Life style
counseling intervention
life style
educational intervention
life style
conventional surgery
life style
pulmonary complications management/prevention
life style
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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.
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
40 Years
120 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Mayo Clinic
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Roberto P. Benzo, MD, MS
Role: STUDY_CHAIR
Mayo Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Clinic
Rochester, Minnesota, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Perrotta F, Cennamo A, Cerqua FS, Stefanelli F, Bianco A, Musella S, Rispoli M, Salvi R, Meoli I. Effects of a high-intensity pulmonary rehabilitation program on the minute ventilation/carbon dioxide output slope during exercise in a cohort of patients with COPD undergoing lung resection for non-small cell lung cancer. J Bras Pneumol. 2019 Oct 14;45(6):e20180132. doi: 10.1590/1806-3713/e20180132. eCollection 2019.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
08-007135
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2009-01148
Identifier Type: REGISTRY
Identifier Source: secondary_id
MC0825
Identifier Type: OTHER
Identifier Source: secondary_id
MC0825
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.