Effect of Pulmonary Rehabilitation on Perioperative Outcomes in Smoker Patients With Lung Cancer
PREPOSE
Effects of Pulmonary Rehabilitation and Airway Management on Short-term and Long-term Perioperative Results of Lobectomy in Smoker Patients With Lung Cancer
1 other identifier
interventional
200
1 country
1
Brief Summary
It is reported that smoker patients (\>400 cigarette/year) will suffer more postoperative complications than non-smoker patients after lobectomy. Evidences has suggested pulmonary rehabilitation could reduce the pulmonary complications after thoracic surgery. However, the effect and long-term results of pulmonary rehabilitation on smoker patients have not been studied. The purpose of this study is to determine whether pulmonary rehabilitation is effective to smoker patients who underwent lobectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 26, 2016
CompletedFirst Posted
Study publicly available on registry
January 4, 2017
CompletedStudy Start
First participant enrolled
January 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedOctober 8, 2021
October 1, 2021
5.6 years
December 26, 2016
October 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
postoperative pulmonary complications
postoperative in-hospital stay up to 30 days
Secondary Outcomes (9)
length of stay (LOS)
postoperative in-hospital stay up to 90 days
therapeutic time of antibiotics
Postoperative in-hospital stay up to 30 days
arterial blood gas analysis
before treatment, 3 days after treatment, 1 day after surgery, 3 days after surgery
vital signs
before treatment, 3 days after treatment, 1 day after surgery, 3 days after surgery
pain score of expectoration
1 day and 3 days after surgery
- +4 more secondary outcomes
Study Arms (2)
regular care
NO INTERVENTION\[Control group\] preoperative treatment: smoking cession, aerosol inhalation for expectorant and antiasthmatic, anti-infection therapy if necessary and regular rehabilitation-propaganda; postoperative treatment: regular postoperative treatment (anti-infection, pain control, oxygen Inhalation aerosol inhalation for expectorant and antiasthmatic), patting back (3 times/day, 15min/time) and early ambulation unless serious patients.
pulmonary rehabilitation
EXPERIMENTAL\[Study group\] preoperative treatment: smoking cession, aerosol inhalation for expectorant and antiasthmatic, anti-infection therapy if necessary, regular rehabilitation-propaganda and interventional pulmonary rehabilitation (preoperative part); postoperative treatment: regular postoperative treatment (anti-infection, pain control, oxygen Inhalation aerosol inhalation for expectorant and antiasthmatic), patting back (3 times/day, 15min/time), early ambulation unless serious patients and interventional pulmonary rehabilitation (postoperative part).
Interventions
pulmonary rehabilitation (preoperative part): lower extremity endurance training (using bike ergometer for 3 days, 2 times/day, 15-20min/time) or stair climbing training (3 days, 2 times/day, 30min/time), keep dyspnea index (Borg) score between 5 to 7 points. And inspiratory muscle training (using threshold inspiratory muscle trainer for 3 days, 5 times/day, 2 sessions/time, every session includes 10-20 cycle respirations). pulmonary rehabilitation (postoperative part): inspiratory muscle training (using threshold inspiratory muscle trainer until hospital discharge, 3-5 times/day, 1 session/time, every session includes 10-20 cycle respirations).
Eligibility Criteria
You may qualify if:
- signed consent
- smoker, ≥400/cigarette year
- surgical approach: open or Video-assisted Thoracoscopic Surgery (VATS) lobectomy
You may not qualify if:
- Serious physical diseases in patients during hospitalization, such as severe heart and lung diseases (CLASS III-IV) (FEV1/FVC \<0.7and FEV1 \<50% predicted value), kidney disease (ESRD change need to continue dialysis), or liver diseases (cirrhosis of the liver accompanied by ascites)
- unable to obey interventional instructions/treatments because of any reasons
- stage IV lung cancer
- emergency surgery
- lung cancer with preoperative chemotherapy, radiotherapy or chemoradiotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ruijin Hospitallead
Study Sites (1)
Ruijin Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, 021, China
Related Publications (1)
Han D, Wang X, Sun X, Cao Y, Li C, Guo W, Hu Y, Hang J, Li J, Xie Q, Li H. Ultra-short-period perioperative pulmonary rehabilitation on short-term outcomes after surgery in smoking patients with lung cancer: a randomized clinical trial. Int J Surg. 2025 Jan 1;111(1):581-588. doi: 10.1097/JS9.0000000000001856.
PMID: 38905498DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
He-Cheng Li, doctor
Ruijin Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 26, 2016
First Posted
January 4, 2017
Study Start
January 20, 2017
Primary Completion
September 1, 2022
Study Completion
December 1, 2022
Last Updated
October 8, 2021
Record last verified: 2021-10