The Impact of Trimodal Prehabilitation Strategy on Patients Undergoing Thoracoscopic Lobectomy
Primary Purpose
Perioperative, Recovery, Prehabilitation
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Trimodal prehabilitation management
Sponsored by
About this trial
This is an interventional prevention trial for Perioperative focused on measuring Perioperative, functional capability, Prehabilitation, thoracoscopic lobectomy, Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Peking Union Medical College Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Prehabilitation group
Control group
Arm Description
Trimodal prehabilitation management
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.
Outcomes
Primary Outcome Measures
6-minute-walking-distance (6MWD)
Use 6-minute-walking-distance (6MWD) to evaluate the physical functional capability objectively.
Secondary Outcome Measures
Quality of Life Scale
Evaluate the intermediate phase of recovery
the version 2 of 12-items Short Form Health Survey(SF 12-v2
Evaluate the late phase physical and mental capability recovery after surgery
WHO disability assessment schedule 2.0 (WHODAS 2.0
Evaluate the global disability in the late phase of recovery
Hospital Anxiety and Depression Scale (HADS)
Evaluate the late phase mental capability recovery after surgery
Full Information
NCT ID
NCT03068507
First Posted
February 27, 2017
Last Updated
October 10, 2018
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03068507
Brief Title
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
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
December 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perioperative, Recovery, Prehabilitation, Thoracoschisis, Lung Cancer, Lobectomy
Keywords
Perioperative, functional capability, Prehabilitation, thoracoscopic lobectomy, Lung Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
patients were randomly assigned to the prehabilitation group and control group by computer-based random numbers concealed in sealed envelopes
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The participant didn't know their group allocation. The doctor of assessment was blinded to group allocation.
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prehabilitation group
Arm Type
Experimental
Arm Description
Trimodal prehabilitation management
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Trimodal prehabilitation management
Intervention Description
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).
Primary Outcome Measure Information:
Title
6-minute-walking-distance (6MWD)
Description
Use 6-minute-walking-distance (6MWD) to evaluate the physical functional capability objectively.
Time Frame
4 weeks postoperatively
Secondary Outcome Measure Information:
Title
Quality of Life Scale
Description
Evaluate the intermediate phase of recovery
Time Frame
the 1st, 2nd and 3rd day postoperatively
Title
the version 2 of 12-items Short Form Health Survey(SF 12-v2
Description
Evaluate the late phase physical and mental capability recovery after surgery
Time Frame
4 weeks postoperatively
Title
WHO disability assessment schedule 2.0 (WHODAS 2.0
Description
Evaluate the global disability in the late phase of recovery
Time Frame
4 weeks postoperatively
Title
Hospital Anxiety and Depression Scale (HADS)
Description
Evaluate the late phase mental capability recovery after surgery
Time Frame
4 weeks postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuguang HUANG, MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
31348053
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.
Results Reference
derived
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The Impact of Trimodal Prehabilitation Strategy on Patients Undergoing Thoracoscopic Lobectomy
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