The Impact of Trimodal Prehabilitation Strategy on Patients Undergoing Thoracoscopic Lobectomy

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03068507
• Other study ID #: PUMCH8888
• Status: Completed
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: December 1, 2017

Study information

• Verified date: October 2018
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 1, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Lobectomy
• Lung Cancer
• Lung Neoplasms
• Perioperative
• Prehabilitation
• Recovery
• Thoracoschisis

Intervention

Behavioral:
• Trimodal prehabilitation management
Trimodal prehabilitation strategy includes physical exercise (moderate aerobic exercise combined with resistance exercise and respiratory training ), nutritional suggestion and optimization(whey protein supplement), and psychological therapy, as well as conventional guidance (including preoperative anesthesia assessment, drug treatment recommendations for chronic disease, quit smoking and abstinence).

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-minute-walking-distance (6MWD)	Use 6-minute-walking-distance (6MWD) to evaluate the physical functional capability objectively.	4 weeks postoperatively
Secondary	Quality of Life Scale	Evaluate the intermediate phase of recovery	the 1st, 2nd and 3rd day postoperatively
Secondary	the version 2 of 12-items Short Form Health Survey(SF 12-v2	Evaluate the late phase physical and mental capability recovery after surgery	4 weeks postoperatively
Secondary	WHO disability assessment schedule 2.0 (WHODAS 2.0	Evaluate the global disability in the late phase of recovery	4 weeks postoperatively
Secondary	Hospital Anxiety and Depression Scale (HADS)	Evaluate the late phase mental capability recovery after surgery	4 weeks postoperatively