Comparing the Impact of Multimodal Prehabilitation to Aerobic Training on Patients Undergoing Thoracoscopic Lobectomy
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
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2019
CompletedFirst Posted
Study publicly available on registry
August 8, 2019
CompletedStudy Start
First participant enrolled
September 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2024
CompletedDecember 28, 2022
August 1, 2022
4.3 years
July 30, 2019
December 26, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
post-operative 6-minute walk distance
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.
30 days postoperatively
Secondary Outcomes (10)
Perioperative 6MWD
baseline, 1 day before surgery
Perioperative pulmonary functional test
Baseline, 1 day before surgery, 30 days postoperatively
Perioperative Hospital Anxiety and Depression Scale (HADS)
Baseline, 1 day before surgery, 30 days postoperatively
WHO disability assessment schedule 2.0 (WHODAS 2.0)
Baseline, 1 day before surgery, 30 days postoperatively
Postoperative quality of recovery score -15 (QoR-15)
the 1st, 2nd and 3rd day postoperatively
- +5 more secondary outcomes
Study Arms (2)
Prehabilitation group
EXPERIMENTALMultimodal 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
EXPERIMENTALAerobic 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
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 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
You may qualify if:
- Outpatient of thoracic surgery department in Peking Union Medical College Hospital
- From 18y/o to 70y/o
- Suspected of lung cancer
- Decide to take the elective thoracoscopic surgery in Peking Union Medical College Hospital
You may not qualify if:
- Decline to participant the study (due to any reason)
- American Society of Anesthesiologists (ASA) grade \>III
- TNM stage I-III
- Patients plan to receive neoadjuvant therapy
- Unable to tolerate prehabilitaion or aerobic strategy (including exercise guide, whey protein and psycho-relaxation exercise)
- Other severe cardio-pulmonary diseases that would affect the 6MWD
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PekingUnionMedicalCollegeHospital
Beijing, Beijing Municipality, 100005, China
Related Publications (1)
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.
PMID: 36922827DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yuguang HUANG, M.D.
Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2019
First Posted
August 8, 2019
Study Start
September 1, 2019
Primary Completion
December 30, 2023
Study Completion
March 30, 2024
Last Updated
December 28, 2022
Record last verified: 2022-08