The Impact of Trimodal Prehabilitation Strategy on Patients Undergoing Thoracoscopic Lobectomy

NCT03068507 | Completed

• 1 other identifier: PUMCH8888
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Perioperative; Recovery; Prehabilitation; Thoracoschisis; Lung Cancer; Lobectomy

Keywords

Perioperative; functional capability; Prehabilitation; thoracoscopic lobectomy; Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 6-minute-walking-distance (6MWD)

  Use 6-minute-walking-distance (6MWD) to evaluate the physical functional capability objectively.

  4 weeks postoperatively

Secondary Outcomes (4)

• Quality of Life Scale

  the 1st, 2nd and 3rd day postoperatively

• the version 2 of 12-items Short Form Health Survey(SF 12-v2

  4 weeks postoperatively

• WHO disability assessment schedule 2.0 (WHODAS 2.0

  4 weeks postoperatively

• Hospital Anxiety and Depression Scale (HADS)

  4 weeks postoperatively

Study Arms (2)

Prehabilitation group

EXPERIMENTAL

Trimodal prehabilitation management

Behavioral: Trimodal prehabilitation management

Control group

NO INTERVENTION

The patients will receive the conventional clinical guidance according to Peking Union Medical College Hospital, including preoperative anesthesia assessment, drug treatment recommendations for chronic disease, quit smoking and abstinence.

Interventions

Trimodal prehabilitation management BEHAVIORAL

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).

Prehabilitation group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (1)

• 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.

  PMID: 31348053 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yuguang HUANG, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participant didn't know their group allocation. The doctor of assessment was blinded to group allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of anesthesisology department

Model Details: patients were randomly assigned to the prehabilitation group and control group by computer-based random numbers concealed in sealed envelopes

Study Record Dates

• First Submitted: February 27, 2017
• First Posted: March 1, 2017
• Study Start: April 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 15, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)