Web-based Home Multimodal Prehabilitation for Patients Undergoing Major Surgeries

NCT05324345 | Unknown

• 1 other identifier: LZJ004
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Prehabilitation is the process of optimizing physical functionality preoperatively to enable the individual to maintain a normal level of function during and after surgery. Prehabilitation training based on aerobic exercise, resistance exercise, breathing exercise, nutrition supplement and physiology management preoperatively could have a positive effect on the recovery of postoperative functional capacity in patients undergoing surgery. Investigators try to construct a short home-based multimodal prehabilitation model based on internetwork in order to improve the efficiency of prehabilitation training, enhance the compliance of patients, and reduce the medical human resources and economic burden. In this study, prehabilitation guidance would be given to preoperative patients through network learning platform. Short-term multi-modal family strategy intervention would perform during the preoperative waiting period, and patients could upload their training records and obtain personalized training guidance by network learning platform follow-up management mode. Investigators would evaluate the feasibility of this model and evaluate its impact on improving the perioperative functional status and prognosis of patients.

Conditions

Perioperative Recovery, Prehabilitation

Keywords

Internet medicine, Prehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in 6-minute walk distance

  Use the change in 6-minute walk distance (6MWD) to evaluate the impact of prehabilitation on functional capability before surgery.

  baseline, 1 day before surgery

Secondary Outcomes (9)

• Body mass index (BMI)

  baseline, 1 day before surgery

• Smoking cessation rate

  baseline, 1 day before surgery

• Grip strength

  baseline, 1 day before surgery

• Forced expiratory volume in 1 s(FEV1)

  baseline, 1 day before surgery

• Forced vital capacity (FVC)

  baseline, 1 day before surgery

Study Arms (1)

Prehabilitation group

EXPERIMENTAL

This is a prospective single-arm study. All patients enrolled in this study will receive the multimodal prehabilitation strategy by the network learning platform after a complete assessment.

Behavioral: Prehabilitation group

Interventions

Prehabilitation group BEHAVIORAL

All patients will be guided to use the network learning platform which including details in text, pictures and videos of their individualized prehabilitation strategy after a complete assessment. Multimodal prehabilitation strategy includes conventional guidance (including preoperative anesthesia assessment, drug treatment recommendations for chronic disease, quit smoking and abstinence), physical exercise (moderate aerobic exercise combined with resistance exercise and respiratory training), nutritional suggestion and optimization (whey protein supplement), and psychological therapy. All movements can be practiced with the reference to the standard videos in the network learning platform. Patients will check the prehabilitation content daily and form their own training tasks in the network learning platform. Standardized short message interviews will be sent to patients twice a week to optimize adherence and promote timely feedback.

Prehabilitation group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients in Peking Union Medical College Hospital between May 2022 to December 2022
• From 18y/o to 70y/o
• Decide to take the elective thoracic surgery or major abdominal surgery (including retroperitoneal 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
• Patients plan to receive neoadjuvant therapy
• Unable to cooperate (including mental disorder, conscious disturbance, and dysgnosia)
• Unable to tolerate prehabilitation or aerobic strategy (including exercise guide, whey protein and psycho-relaxation exercise)
• Unable to use a smartphone or unable to read Chinese
• Local anesthesia or low-risk surgery (superficial surgery, outpatient surgery, or anticipated operation time \<1 hour);
• People who have an average of more than 90 minutes of moderate intensity aerobic exercise or more than 60 minutes of high intensity exercise per week.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Officials

• Zijia LIU, M.D.

  Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences

  STUDY CHAIR

Central Study Contacts

Zijia LIU, M.D.

CONTACT

86-10-69152020; liu-zj02@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 12, 2022
• Study Start: September 1, 2023
• Primary Completion: October 31, 2023
• Study Completion: March 1, 2024
• Last Updated: September 5, 2023

Record last verified: 2023-08