The Impact of Trimodal Prehabilitation Strategy on Patients Undergoing Thoracoscopic Lobectomy
Condition: Perioperative; Recovery; Prehabilitation; Thoracoschisis; Lung Cancer; Lobectomy
MeSH terms: Lung Neoplasms
Study type: Interventional

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.).
    

Intervention name(s): Trimodal prehabilitation management
Intervention type(s): Behavioral
Intervention description(s): 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).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: patients were randomly assigned to the prehabilitation group and control group by computer-based random numbers concealed in sealed envelopes
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Perioperative; functional capability; Prehabilitation; thoracoscopic lobectomy; Lung Cancer