Perioperative Recovery, PrehabilitationNCT05324345
Web-based Home Multimodal Prehabilitation for Patients Undergoing Major Surgeries
A study testing Prehabilitation group in people with Perioperative Recovery, Prehabilitation, run by Peking Union Medical College Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Perioperative Recovery, Prehabilitation
- What is being tested?
- Prehabilitation group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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).
- Conditions
- Perioperative Recovery, Prehabilitation
- Being tested
- Prehabilitation group
- Keywords
- Internet medicine, Prehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehabilitation groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Prehabilitation group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 1 day before surgery
Secondary outcomes (9)
Body mass index (BMI)
Body mass index (BMI) will be calculated by formula: BMI=weight(kg)/height(m)^2.
Measured: baseline, 1 day before surgery
Smoking cessation rate
The number of smokers will be collected at baseline and 1 day before surgery, and smoking cessation rates will be calculated.
Measured: baseline, 1 day before surgery
Grip strength
The grip strength of the hand will be measured by a grip strength tester (Jamar Plus+ Hand Evaluation Kit).
Measured: baseline, 1 day before surgery
Forced expiratory volume in 1 s(FEV1)
Forced expiratory volume in 1 s (FEV1) of pulmonary function will be measured in liters.
Measured: baseline, 1 day before surgery
Forced vital capacity (FVC)
Forced vital capacity (FVC) of pulmonary function will be measured in liters.
Measured: baseline, 1 day before surgery
Forced expiratory volume in 1 s / Forced vital capacity (FEV1/FVC)
FEV1/FVC will be calculated with the FEV1 and FVC value and reported in percentage.
Measured: baseline, 1 day before surgery
Duke Activity Status Index (DASI)
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.
Measured: baseline, 1 day before surgery
Nutritional risk screening scale (NRS-2002)
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.
Measured: baseline, 1 day before surgery
Hospital Anxiety and Depression Scale (HADS)
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.
Measured: baseline, 1 day before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start1 Sep 2023 (estimated)
- Primary completion31 Oct 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative Recovery, PrehabilitationStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zijia LIU, M.D., Study chair, Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05324345
- Sponsor's protocol ID
- LZJ004
- Status last verified
- Aug 2023
- First submitted
- 31 Mar 2022
- Last updated
- 5 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05324345
- Acronym / sponsor ID
- LZJ004
- Conditions
- Perioperative Recovery, Prehabilitation
- Keywords
- Internet medicine, Prehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation group | Experimental | Behavioral: Prehabilitation groupThis 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prehabilitation groupAll 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. | Behavioural | Prehabilitation group |
Primary outcome
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.
9 secondary outcomes
Body mass index (BMI)
Time frame: baseline, 1 day before surgery
Smoking cessation rate
Time frame: baseline, 1 day before surgery
Grip strength
Time frame: baseline, 1 day before surgery
Forced expiratory volume in 1 s(FEV1)
Time frame: baseline, 1 day before surgery
Forced vital capacity (FVC)
Time frame: baseline, 1 day before surgery
Forced expiratory volume in 1 s / Forced vital capacity (FEV1/FVC)
Time frame: baseline, 1 day before surgery
Duke Activity Status Index (DASI)
Time frame: baseline, 1 day before surgery
Nutritional risk screening scale (NRS-2002)
Time frame: baseline, 1 day before surgery
Hospital Anxiety and Depression Scale (HADS)
Time frame: baseline, 1 day before surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zijia LIU, M.D. study chair
Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation group in people with Perioperative Recovery, Prehabilitation, run by Peking Union Medical College Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zijia LIU, M.D. (86-10-69152020, liu-zj02@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 6-minute walk distance (time frame: baseline, 1 day before surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.