Comparing the Impact of Multimodal Prehabilitation to Aerobic Training on Patients Undergoing Thoracoscopic Lobectomy
NCT ID: NCT04049942
Last Updated: 2022-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2019-09-01
2024-03-30
Brief Summary
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Detailed Description
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The purpose of prehabilitation is to enhance an individual's functional capacity to reach the optimal physiological state before surgery, helping them withstand the stress of surgery and receive an enhanced recovery post operation. Recent studies have shown that trimodal or multimodal prehabilitation strategy including exercise, diet and psychologic guidance could improve postoperative functional recovery for patients undergoing colorectal resection. However, researches regarding to the effect of multi-modal prehabilitation in other types of operations remain scarce.
Studies have shown that the postoperative functional capacity decreases in patients undergoing lung cancer surgery. Therefore, many clinical trials were designed to explore the impact of prehabilitation on these patients, and many of them yielded positive results, showing preoperative exercise for patients undergoing lung cancer surgery is safe and beneficial in postoperative functional capacity recovery. However, the majority of the trials conducted adopted preoperative exercises, specifically aerobic exercises, as the sole means of prehabilitation. In 2017, our team conducted a randomized controlled trial (registration number NCT03068507) to examine the efficacy of a 2-week multimodal home-based prehabilitation strategy in patients undergoing VATS lobectomy for lung cancer. The preliminary results indicate that patients who received the short multimodal home-based prehabilitation have a significantly higher 6-minute walk distance (6MWD) perioperatively.
Investigators are proposing a new randomized controlled trial to compare the efficacy of a short multimodal home-based prehabilitation with the sole aerobic prehabilitation strategy adopted by the previous studies.
A total of 100 patients scheduled to have elective VATS lobectomy for primary lung cancer will be recruited in this research at Peking Union Medical College Hospital. After informed consent is obtained, the patients will be evenly assigned to two groups randomly based on computer-generated sequence, the multimodal prehabilitation group and the aerobic prehabilitation group. The random allocation will be concealed using sealed opaque envelops.
The multimodal group will receive an individualized prehabilitation strategy after a complete assessment, including aerobic and resistance exercise, nutritional optimization, and psychological therapy, as well as conventional guidance. All patients will receive an instruction booklet with details in text and pictures, and will be asked to complete standard diaries in the booklet. The length of prehabilitation will be 2-3 weeks, determined by the waiting time till surgery alone.
For the multimodal group, prehabilitation strategy is as follows: 1) a 30-minute aerobic exercise at least 3 times a week, in the form of jogging, power walking or cycling, according to the patients' individual choice; 2) a guided resistance exercise at least twice a week, using a pull strap distributed by investigators to accomplish 4 pre-set resistance posture; 3) breathing exercise at least 3 times per day, lasting over 10 minutes, in the form of guided effective coughing, blowing up a small balloon or using the respiratory exerciser distributed by investigators; 4) nutritional advice and whey protein supplement 1hour prior to exercising (20g/day for male and 15g/day for female patients); 5) psychological therapy by listening to soothing music or radio and other relaxing activities. Patients are advised to record daily exercises and adherence to nutritional, psychological and other recommendations in a prehabilitation journal distributed by investigators. Standardized short message interviews are sent to patients twice a week to optimize adherence and promote timely feedback.
The aerobic group will receive the same guidance in the individualized home-based aerobic exercise strategy as the multimodal group, but not in the other aspects. These patients are also advised to keep a prehabilitation journal recording daily exercises and will receive the same short message interviews twice a week.
All patients enrolled will receive the conventional guidance, including preoperative anesthesia assessment, drug treatment recommendations for chronic disease, quit smoking and abstinence. And patients are also provided some useful information about anesthesia and surgery process.
The patients and trial personnel will not be blinded to the allocation regarding to the nature of the intervention. The outcome assessors will independently collect the outcome data without the knowledge of the allocation.
The primary outcome will be post-operative 6-minute walk distance (6MWD), measured as functional walking capacity, at 30 days postoperatively). The secondary outcomes include perioperative 6MWD (1 day before surgery, 30 days postoperatively), pulmonary function (1 day before surgery, 30 days postoperatively), hospital anxiety and depression scale (HADS), World Health Organization disability assessment schedule II (WHODAS 2.0) score, postoperative quality of recovery score -15 (QoR-15) score and prognosis information (mortality and morbidity, length of hospital stay, ICU stay time, duration of chest tube, etc.).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Prehabilitation group
Multimodal 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). Patients are advised to record daily exercises and adherence to nutritional, psychological and other recommendations. Short message interviews are sent to patients twice a week to optimize adherence and promote feedback.
Multimodal prehabilitation group
Multimodal 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). Patients are advised to record daily exercises and adherence to nutritional, psychological and other recommendations. Short message interviews are sent to patients twice a week to optimize adherence and promote feedback.
Aerobic training group
Aerobic training strategy includes the same guided individualized moderate aerobic exercise as the multimodal prehabilitation group, as well as the conventional guidance. Patients are advised to record daily exercises. Short message interviews are sent to patients twice a week to optimize adherence and promote feedback.
Aerobic training group
Aerobic training strategy includes the same guided individualized moderate aerobic exercise as the multimodal prehabilitation group, as well as the conventional guidance. Patients are advised to record daily exercises. Short message interviews are sent to patients twice a week to optimize adherence and promote feedback.
Interventions
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Multimodal prehabilitation group
Multimodal 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). Patients are advised to record daily exercises and adherence to nutritional, psychological and other recommendations. Short message interviews are sent to patients twice a week to optimize adherence and promote feedback.
Aerobic training group
Aerobic training strategy includes the same guided individualized moderate aerobic exercise as the multimodal prehabilitation group, as well as the conventional guidance. Patients are advised to record daily exercises. Short message interviews are sent to patients twice a week to optimize adherence and promote feedback.
Eligibility Criteria
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Inclusion Criteria
2. From 18y/o to 70y/o
3. Suspected of lung cancer
4. Decide to take the elective thoracoscopic surgery in Peking Union Medical College Hospital
Exclusion Criteria
2. American Society of Anesthesiologists (ASA) grade \>III
3. TNM stage I-III
4. Patients plan to receive neoadjuvant therapy
5. Unable to tolerate prehabilitaion or aerobic strategy (including exercise guide, whey protein and psycho-relaxation exercise)
6. Other severe cardio-pulmonary diseases that would affect the 6MWD
18 Years
70 Years
ALL
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Principal Investigators
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Yuguang HUANG, M.D.
Role: STUDY_CHAIR
Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
Locations
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PekingUnionMedicalCollegeHospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Zijia Liu, MD
Role: primary
References
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Liu Y, Liu Z, Zhang Y, Cui Y, Pei L, Huang Y. The protocol for the prehabilitation for thoracic surgery study: a randomized pragmatic trial comparing a short home-based multimodal program to aerobic training in patients undergoing video-assisted thoracoscopic surgery lobectomy. Trials. 2023 Mar 15;24(1):194. doi: 10.1186/s13063-023-07220-4.
Other Identifiers
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LZJ002
Identifier Type: -
Identifier Source: org_study_id