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The Impact of Trimodal Prehabilitation Strategy on Patients Undergoing Thoracoscopic Lobectomy

The Impact of Trimodal Prehabilitation Strategy on Perioperative Functional Capability and Prognosis of Patients Undergoing Thoracoscopic Lobectomy for Lung Cancer:a Randomized Controlled Trail

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03068507
Enrollment
100
Registered
2017-03-01
Start date
2017-04-01
Completion date
2017-12-01
Last updated
2018-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lobectomy, Lung Cancer, Perioperative, Prehabilitation, Recovery, Thoracoschisis

Keywords

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

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.).

Interventions

BEHAVIORALTrimodal 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).

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

The participant didn't know their group allocation. The doctor of assessment was blinded to group allocation.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
6-minute-walking-distance (6MWD)4 weeks postoperativelyUse 6-minute-walking-distance (6MWD) to evaluate the physical functional capability objectively.

Secondary

MeasureTime frameDescription
Quality of Life Scalethe 1st, 2nd and 3rd day postoperativelyEvaluate the intermediate phase of recovery
the version 2 of 12-items Short Form Health Survey(SF 12-v24 weeks postoperativelyEvaluate the late phase physical and mental capability recovery after surgery
WHO disability assessment schedule 2.0 (WHODAS 2.04 weeks postoperativelyEvaluate the global disability in the late phase of recovery
Hospital Anxiety and Depression Scale (HADS)4 weeks postoperativelyEvaluate the late phase mental capability recovery after surgery

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026