Clinical trial NCT05324345: Web-based Home Multimodal Prehabilitation for Patients Undergoing Major Surgeries
Official title: The Construction and Application of a Web-based Home Multimodal Prehabilitation Program in Patients Undergoing Thoracic and Major Abdominal Surgeries: a Single-arm Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Perioperative Recovery, Prehabilitation
Keywords: Internet medicine, Prehabilitation
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Detailed description: Trimodal or multimodal prehabilitation strategy including exercise, diet and psychologic guidance could improve postoperative functional recovery for patients undergoing surgery. The development of internet medical provides possibility to improve the efficiency of patients' preoperative education, enhance the accuracy of prehabilitation execution, and reduce the medical human resources and economic burden.

This study tries to build the patient-centered network education and follow-up management based on the internet learning platform.

This is a prospective arm study. A total of 40 patients scheduled to have elective major thoracic, abdominal and retroperitoneal surgery (including thoracoscopic and laparoscopic surgery) will be recruited in this research at Peking Union Medical College Hospital. After informed consent is obtained, the baseline data (including basic information, past medical history, initial 6-minute walk distance, grip strength, pulmonary function et.al) will be collected. 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. Prehabilitation strategy is as follows: (1) quit smoking and abstinence; (2) a 5-minute warm-up exercise and a 25-minute aerobic exercise in the form of power walking, jogging, or cycling at least 3 times a week; (3) anaerobic exercise in form of bodyweight muscle training or pull strap training at least twice a week; (4) patients scheduled to have elective thoracic surgery also need to do breathing exercise in the form of blowing balloons, blowing the respiratory exerciser Tri-Ball, and active cycle of breathing techniques at least twice a day, 10 minutes each time; (5) nutritional advice and whey protein supplement 1 hour prior to exercise (20g/day for male and 15g/day for female patients); (6) psychological therapy by listening to soothing music and other relaxing activities. All details can be practiced with the reference to the standard videos in thenetwork 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.

The length of prehabilitation will be 2-3 weeks, determined by the waiting time till surgery alone. After admission, the utilization rate of the prehabilitation network learning platform, the implementation of the prehabilitation strategy and the satisfaction with the network learning platform will be collected. Change of the following indicators from baseline to 1 day before surgery will be collected. The primary outcome is the change in 6-minute walk distance (6MWD), measured as functional walking capacity. The secondary outcomes include body-mass index(BMI), smoking cessation rate, grip strength, forced expiratory volume in 1 s (FEV1), forced vital capacity (FVC), FEV1/FVC, Duke Activity Status Index(DASI), Nutritional risk screening scale (NRS-2002), and Hospital Anxiety and Depression Scale (HADS).

Eligibility criteria: Inclusion Criteria:

1. Outpatients in Peking Union Medical College Hospital between May 2022 to December 2022
2. From 18y/o to 70y/o
3. Decide to take the elective thoracic surgery or major abdominal surgery (including retroperitoneal 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. Patients plan to receive neoadjuvant therapy
4. Unable to cooperate (including mental disorder, conscious disturbance, and dysgnosia)
5. Unable to tolerate prehabilitation or aerobic strategy (including exercise guide, whey protein and psycho-relaxation exercise)
6. Unable to use a smartphone or unable to read Chinese
7. Local anesthesia or low-risk surgery (superficial surgery, outpatient surgery, or anticipated operation time \<1 hour);
8. 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.

Primary outcomes:
measure: Change in 6-minute walk distance
timeFrame: baseline, 1 day before surgery
Secondary outcomes:
measure: Body mass index (BMI)
timeFrame: baseline, 1 day before surgery
measure: Smoking cessation rate
timeFrame: baseline, 1 day before surgery
measure: Grip strength
timeFrame: baseline, 1 day before surgery
measure: Forced expiratory volume in 1 s(FEV1)
timeFrame: baseline, 1 day before surgery
measure: Forced vital capacity (FVC)
timeFrame: baseline, 1 day before surgery
measure: Forced expiratory volume in 1 s / Forced vital capacity (FEV1/FVC)
timeFrame: baseline, 1 day before surgery
measure: Duke Activity Status Index (DASI)
timeFrame: baseline, 1 day before surgery
measure: Nutritional risk screening scale (NRS-2002)
timeFrame: baseline, 1 day before surgery
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: baseline, 1 day before surgery
Other outcomes:
Locations:
Study officials:
affiliation: Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
name: Zijia LIU, M.D.
role: STUDY_CHAIR
References: