Clinical trial NCT03068507: The Impact of Trimodal Prehabilitation Strategy on Patients Undergoing Thoracoscopic Lobectomy
Official title: The Impact of Trimodal Prehabilitation Strategy on Perioperative Functional Capability and Prognosis of Patients Undergoing Thoracoscopic Lobectomy for Lung Cancer：a Randomized Controlled Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perioperative
Recovery
Prehabilitation
Thoracoschisis
Lung Cancer
Lobectomy
Keywords: Perioperative
functional capability
Prehabilitation
thoracoscopic lobectomy
Lung Cancer
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2017-03-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients were randomly assigned to the prehabilitation group and control group by computer-based random numbers concealed in sealed envelopes
Primary purpose: PREVENTION

Brief summary: The process of enhancing an individual's functional capacity to optimize physiologic reserves before an operation to withstand the stress of surgery has been coined prehabilitation. This is a prospective randomized controlled trail, designed to explore if the patients who take thoracoscopic lobectomy for lung cancer will benefit from family trimodal prehabilitation strategy. Trimodal prehabilitation includes exercise, nutrition supplement and physiology management preoperatively. It starts from the day that patients decide to take the surgery until the day before surgery, lasting 2\~3 week in our hospital. And we follow-up patients until 8 weeks after surgery to investigate if trimodal prehabilitation strategy can improve the postoperative functional recovery，reduce complications and improve prognosis.

Detailed description: This is a prospective randomized controlled trail, which focus on the impact of family prehabilitaiton strategy on the patients undertaking thoracoscopic lobectomy for lung cancer.

The process of enhancing an individual's functional capacity to optimize physiologic reserves before an operation to withstand the stress of surgery has been coined prehabilitation. It has been confirm that trimodal prehabilitation strategy including exercise, diet and psychology guidance could improve postoperative functional recovery after surgery for patients undergoing colorectal resection. But there has been no research about the impact of trimodal prehabilitation in other operations.

Although many clinical studies have confirmed that preoperative exercise for patients undergoing lung cancer surgery is safe and useful, but so far there are few studies investigated perioperative functional capability in population undergoing thoracoscopic lobectomy. And no study extends preoperative exercise to trimodal prehabilitation adding nutritional and psychological management. In addition, the prehabilitation strategy in previous studies usually takes 4\~8 weeks. However, patient suspected of malignant tumor often wouldn't wait for such a long period. We therefore designed this study to investigate if a 2\~3 week family trimodal prehabilitation strategy benefits the patients undergoing thoracoscopic lobectomy for lung caner.

There will be 100 patients awaiting elective thoracoscopic lobectomy for primary lung cancer recruited in this research at Peking Union Medical College Hospital. After informed consent was obtained, the patients will be divided into two groups randomly, the prehibilitation group and control group.

The prehabilitation group will receive an individual trimodal prehabilitation strategy after a complete assessment, including physical exercise, nutritional optimization, and psychological therapy, as well as conventional guidance. The length of prehabilitation was determined by the waiting time till surgery alone. The control group will receive the conventional guidance, including preoperative anesthesia assessment, drug treatment recommendations for chronic disease, quit smoking and abstinence. Both of the groups are also provided some useful information about anesthesia and surgery process.

The functional capability will be examined for both groups at several time points (baseline, the day before surgery, 1st, 2nd and 3rd day postoperatively, 4 weeks postoperatively and 8 weeks postoperatively) The primary end point is functional walking capacity as measured by the 6 minutes walking distance (6MWD) 4 weeks postoperatively. The secondary end points include lung function improvement (baseline vs. preoperative) ， self-reported physical activity, health-related quality of life scales and prognosis information (postoperative complications, length of hospital stay, ICU stay time, hospitalization expenses, etc.).

Eligibility criteria: Inclusion Criteria:

1. Outpatient of thoracic surgery department in Peking Union Medical College Hospital
2. From 18 y/o to 70 y/o
3. Suspected of lung cancer
4. Decide to take the elective thoracoscopic surgery in Peking Union Medical College Hospital

Exclusion Criteria:

1. Refuse or fail to cooperate the study (due to any reason)
2. ASA grade ≥ III
3. Unable to tolerate prehabilitaion strategy (including exercise guide, whey protein and psycho-relaxation exercise)
4. Other severe cardio-pulmonary diseases that would affect the 6MWD

Primary outcomes:
measure: 6-minute-walking-distance (6MWD)
timeFrame: 4 weeks postoperatively
Secondary outcomes:
measure: Quality of Life Scale
timeFrame: the 1st, 2nd and 3rd day postoperatively
measure: the version 2 of 12-items Short Form Health Survey(SF 12-v2
timeFrame: 4 weeks postoperatively
measure: WHO disability assessment schedule 2.0 (WHODAS 2.0
timeFrame: 4 weeks postoperatively
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 4 weeks postoperatively
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Yuguang HUANG, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liu Z, Qiu T, Pei L, Zhang Y, Xu L, Cui Y, Liang N, Li S, Chen W, Huang Y. Two-Week Multimodal Prehabilitation Program Improves Perioperative Functional Capability in Patients Undergoing Thoracoscopic Lobectomy for Lung Cancer: A Randomized Controlled Trial. Anesth Analg. 2020 Sep;131(3):840-849. doi: 10.1213/ANE.0000000000004342.