Comparing the Impact of Multimodal Prehabilitation to Aerobic Training on Patients Undergoing Thoracoscopic Lobectomy

• ClinicalTrials.gov Identifier: NCT04049942
• Recruitment Status: Recruiting
• First Posted: August 8, 2019
• Last Update Posted: December 28, 2022
• Sponsor: Peking Union Medical College Hospital
• Information provided by (Responsible Party): Peking Union Medical College Hospital

Study Description

Brief Summary:

In recent years, many studies have shown that prehabilitation based on aerobic training strategies could have a positive effect on the recovery of postoperative functional capacity in patients undergoing lung cancer surgery. Investigators are proposing a prospective randomized controlled trial to compare the impact of a short home-based multimodal prehabilitation strategy to preoperative aerobic training on patients scheduled for video-assisted thorascopic lobectomy for lung cancer. The multimodal prehabilitation strategy includes guided aerobic and resistance exercise, breathing exercises, nutrition supplement and physiology management preoperatively, while the aerobic strategy offers the same aerobic training guidance without the other parts. The prehabilitation lasts 2-3 weeks in our center. Investigators follow-up patients until 30 days after surgery, to investigate whether multimodal prehabilitation strategy differs from aerobic training program in postoperative functional capability improvement, health-related quality of life scorings, incidence of postoperative complications and other outcomes.

Condition or disease	Intervention/treatment	Phase
Perioperative; Recovery; Prehabilitation; Thoracoschisis; Lobectomy; Lung Cancer	Other: Multimodal prehabilitation group; Behavioral: Aerobic training group	Not Applicable

Detailed Description:

This is a randomized controlled trial comparing the impact of a short home-based multimodal prehabilitaiton strategy to preoperative aerobic training program on patients undertaking video-assisted thoracoscopic (VATS) lobectomy for lung cancer.

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.).

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: The Comparison of a Short Home-based Multimodal Prehabilitation Strategy to Preoperative Aerobic Training Program on the Perioperative Functional Capacity and Outcomes in Patients Undergoing Thoracoscopic Lobectomy
• Actual Study Start Date: September 1, 2019
• Estimated Primary Completion Date: December 30, 2023
• Estimated Study Completion Date: March 30, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Other: 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.
Experimental: 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.	Behavioral: 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.

Outcome Measures

Primary Outcome Measures :

1. post-operative 6-minute walk distance [ Time Frame: 30 days postoperatively ]
   Use 6-minute walk distance (6MWD) to evaluate the physical functional capability objectively. The primary outcome will be analyzed after stratification by age and baseline functional capacity.

Secondary Outcome Measures :

1. Perioperative 6MWD [ Time Frame: baseline, 1 day before surgery ]
   Evaluate the impact of prehabilitation on functional capability before surgery.
2. Perioperative pulmonary functional test [ Time Frame: Baseline, 1 day before surgery, 30 days postoperatively ]
   Evaluate the recovery of pulmonary capacity. Forced expiratory volume in 1 s (FEV1) and forced vital capacity (FVC) will be measured in liters, and FEV1/FVC will be calculated with the FEV1 and FVC value and reported in percentage.
3. Perioperative Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline, 1 day before surgery, 30 days postoperatively ]
   The HADS is a questionnaire composed of 14 questions to screen for anxiety and depression. The questionnaire features 7 questions on anxiety and seven on depression. The maximum score for either anxiety or depression is 21 and the minimum for either is 0. The severity of anxiety and depression correlates with the scoring. HADS will be used to evaluate the mental capability recovery after surgery.
4. WHO disability assessment schedule 2.0 (WHODAS 2.0) [ Time Frame: Baseline, 1 day before surgery, 30 days postoperatively ]
   WHODAS 2.0 is a patient self-report assessment tool that evaluates the patient's ability to perform activities in six domains of functioning over the previous 30 days. Each item from the six domains is rated using a 5-point Likert scale (1 = no difficulty, 2 = mild difficulty, 3 = moderate difficulty, 4 = severe difficulty, 5 = extreme difficulty). These are then calculated to get a score representing global disability. WHODAS 2.0 will be adopted to make the the global evaluation of patients' disability before and after surgery.
5. Postoperative quality of recovery score -15 (QoR-15) [ Time Frame: the 1st, 2nd and 3rd day postoperatively ]
   QoR-15 is an easy-to-use score for assessing the quality of post-operative recovery. It is a questionnaire featuring 15 items, each of which has a scale of 0 to 10. Higher scores of QoR-15 indicate better recovery quality after surgery. QoR-15 will be used in this study to evaluate the intermediate phase of recovery.
6. Prognosis information1: mortality [ Time Frame: 30 days postoperatively ]
   Evaluate postoperative all-cause mortality, reported in percentage.
7. Prognosis information2: morbidity [ Time Frame: 30 days postoperatively ]
   Evaluate the incidence of major postoperative complications including atelectasis, pneumonia, respiratory failure, sepsis, septic shock, which will be all reported in percentage.
8. Prognosis information3: length of hospital stay [ Time Frame: 30 days postoperatively ]
   Evaluate postoperative length of hospital stay, reported in days.
9. Prognosis information4: ICU stay time [ Time Frame: 30 days postoperatively ]
   Evaluate postoperative ICU stay time, reported in days.
10. Prognosis information5: duration of chest tube [ Time Frame: 30 days postoperatively ]
    Evaluate duration of chest tube placement, reported in days.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Outpatient of thoracic surgery department in Peking Union Medical College Hospital
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:

1. Decline to participant the study (due to any reason)
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

Contacts and Locations

Contacts

Contact: Yuguang HUANG, M.D.; 86-10-69152060; garypumch@163.com

Locations

China, Beijing

PekingUnionMedicalCollegeHospital; Recruiting

Beijing, Beijing, China, 100005

Contact: Zijia Liu, MD 0086-18501155710

Sponsors and Collaborators

Peking Union Medical College Hospital

Investigators

• Study Chair: Yuguang HUANG, M.D.; Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences

More Information

• Responsible Party: Peking Union Medical College Hospital
• ClinicalTrials.gov Identifier: NCT04049942
• Other Study ID Numbers: LZJ002
• First Posted: August 8, 2019
• Last Update Posted: December 28, 2022
• Last Verified: August 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Peking Union Medical College Hospital:

Perioperative; Functional capability; Prehabilitation; Thoracoscopic lobectomy; Lung Cancer

Additional relevant MeSH terms:

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