NCT00363428

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable lung-cancer

Timeline
Completed

Started Aug 2006

Longer than P75 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 15, 2006

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

July 19, 2017

Status Verified

July 1, 2017

Enrollment Period

6.3 years

First QC Date

August 10, 2006

Last Update Submit

July 17, 2017

Conditions

Lung CancerPerioperative/Postoperative ComplicationsPulmonary ComplicationsTobacco Use Disorder

Keywords

pulmonary complicationsperioperative/postoperative complicationstobacco use disordernon-small cell lung cancersmall cell lung cancer

Outcome Measures

Primary Outcomes (1)

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

    12 weeks

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Control

PLACEBO COMPARATOR

Receive standard care and educational material on exercise and lifestyle choices of well-being

Behavioral: exercise interventionBehavioral: smoking cessation interventionOther: counseling interventionOther: educational interventionProcedure: conventional surgeryProcedure: pulmonary complications management/prevention

Lifestyle intervention

EXPERIMENTAL
Behavioral: exercise interventionBehavioral: smoking cessation interventionOther: counseling interventionOther: educational interventionProcedure: conventional surgeryProcedure: pulmonary complications management/prevention

Interventions

exercise interventionBEHAVIORAL

life style

ControlLifestyle intervention
smoking cessation interventionBEHAVIORAL

Life style

ControlLifestyle intervention
counseling interventionOTHER

life style

ControlLifestyle intervention
educational interventionOTHER

life style

ControlLifestyle intervention
conventional surgeryPROCEDURE

life style

ControlLifestyle intervention
pulmonary complications management/preventionPROCEDURE

life style

ControlLifestyle intervention

Eligibility Criteria

Age40 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • 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.

    PMID: 31618297DERIVED

MeSH Terms

Conditions

Lung NeoplasmsPostoperative ComplicationsTobacco Use DisorderCarcinoma, Non-Small-Cell LungSmall Cell Lung Carcinoma

Interventions

CounselingEarly Intervention, Educational

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSubstance-Related DisordersChemically-Induced DisordersMental DisordersCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesChild Health ServicesPreventive Health Services

Study Officials

  • Roberto P. Benzo, MD, MS

    Mayo Clinic

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2006

First Posted

August 15, 2006

Study Start

August 1, 2006

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

July 19, 2017

Record last verified: 2017-07

Locations

US(1)