Web-based Home Multimodal Prehabilitation for Patients Undergoing Major Surgeries

August 30, 2023 updated by: Peking Union Medical College Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Prehabilitation group
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in 6-minute walk distance
Time Frame: baseline, 1 day before surgery
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body mass index (BMI)
Time Frame: baseline, 1 day before surgery
Body mass index (BMI) will be calculated by formula: BMI=weight(kg)/height(m)^2.
baseline, 1 day before surgery
Smoking cessation rate
Time Frame: baseline, 1 day before surgery
The number of smokers will be collected at baseline and 1 day before surgery, and smoking cessation rates will be calculated.
baseline, 1 day before surgery
Grip strength
Time Frame: baseline, 1 day before surgery
The grip strength of the hand will be measured by a grip strength tester (Jamar Plus+ Hand Evaluation Kit).
baseline, 1 day before surgery
Forced expiratory volume in 1 s(FEV1)
Time Frame: baseline, 1 day before surgery
Forced expiratory volume in 1 s (FEV1) of pulmonary function will be measured in liters.
baseline, 1 day before surgery
Forced vital capacity (FVC)
Time Frame: baseline, 1 day before surgery
Forced vital capacity (FVC) of pulmonary function will be measured in liters.
baseline, 1 day before surgery
Forced expiratory volume in 1 s / Forced vital capacity (FEV1/FVC)
Time Frame: baseline, 1 day before surgery
FEV1/FVC will be calculated with the FEV1 and FVC value and reported in percentage.
baseline, 1 day before surgery
Duke Activity Status Index (DASI)
Time Frame: baseline, 1 day before surgery
Evaluate the patients'functional capacity. The Duke Activity Status Index (DASI) is a 12-item scale (in the form of a self-administered questionnaire) that correlates well with peak oxygen uptake (Spearman correlation coefficient 0.80). DASI score is calculated by adding the points of all performed activities together. The higher the score (ranges from 0 to 58.2) the higher the functional status.
baseline, 1 day before surgery
Nutritional risk screening scale (NRS-2002)
Time Frame: baseline, 1 day before surgery
Evaluate the patients' nutritional risk. NRS includes assessment of the patient's disease severity (stress metabolism due to the degree of disease) and nutritional status (based on weight loss, body mass index (BMI) and general condition or food intake). Each section is scored from 0 to 3 points, and patients receive an extra point if they are 70 years or older.
baseline, 1 day before surgery
Hospital Anxiety and Depression Scale (HADS)
Time Frame: baseline, 1 day before surgery
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 impact of prehabilitation of mental capability.
baseline, 1 day before surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking Union Medical College Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Zijia LIU, M.D., Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 12, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LZJ004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Perioperative Recovery, Prehabilitation

Clinical Trials on Prehabilitation group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings