PerioperativeNCT03068507
The Impact of Trimodal Prehabilitation Strategy on Patients Undergoing Thoracoscopic Lobectomy
A study testing Trimodal prehabilitation management in people with Perioperative and Recovery, run by Peking Union Medical College Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Perioperative, Recovery, Prehabilitation
- What is being tested?
- Trimodal prehabilitation management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2017to 1 Dec 2017
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
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
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.
Read the 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.).
- Conditions
- Perioperative, Recovery, Prehabilitation, Thoracoschisis, Lung Cancer, Lobectomy
- Being tested
- Trimodal prehabilitation management
- Keywords
- Perioperative, functional capability, Prehabilitation, thoracoscopic lobectomy, Lung Cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trimodal prehabilitation managementBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation group | Experimental | Trimodal prehabilitation management Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute-walking-distance (6MWD)
Use 6-minute-walking-distance (6MWD) to evaluate the physical functional capability objectively.
Measured: 4 weeks postoperatively
Secondary outcomes (4)
Quality of Life Scale
Evaluate the intermediate phase of recovery
Measured: the 1st, 2nd and 3rd day postoperatively
the version 2 of 12-items Short Form Health Survey(SF 12-v2
Evaluate the late phase physical and mental capability recovery after surgery
Measured: 4 weeks postoperatively
WHO disability assessment schedule 2.0 (WHODAS 2.0
Evaluate the global disability in the late phase of recovery
Measured: 4 weeks postoperatively
Hospital Anxiety and Depression Scale (HADS)
Evaluate the late phase mental capability recovery after surgery
Measured: 4 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start1 Apr 2017
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PerioperativeStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- patients were randomly assigned to the prehabilitation group and control group by computer-based random numbers concealed in sealed envelopes
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huang YuGuang, Peking Union Medical College Hospital
- Investigators
- Yuguang HUANG, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068507
- Sponsor's protocol ID
- PUMCH8888
- Status last verified
- Oct 2018
- First submitted
- 27 Feb 2017
- Last updated
- 15 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 31348053