Multidisciplinary Prehabilitation Management Pathway and Network Platform Construction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 64
- Primary Endpoint
- 6 minute walking test distance, 6MWD
Study Overview
Brief Summary
The goal of this clinical trial is to learn if "Prehabilitation model for Internet+ devices"improve patients' preoperative status and reduce the postoperative recovery time, postoperative complications，comparing to trditional prehabilitation model. The main questions it aims to answer are:
- Does the Prehabilitation model for Internet+ devices works out?
- Does"Prehabilitation model for Internet+ devices" better increase the patient's six-minute walk test distance?
Participants will:
Take Internet+devices model or traditional model to prehabilitation for 2-4weeks.
Test 6MWT before operation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Masking Description
Block randomized number will be prepared in advance and be hidden in the envelope. At the time of collecting the participants' baseline information, neither the participants nor the investigator knew which intervention the patients would receive. After the information was collected, the envelopes were opened to determine whether participants were assigned to the intervention or control group.
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age: 18-75 years;
- •adults with suspected lung cancer proposed for VATS lobectomy/sublobar resection.
Exclusion Criteria
- •Patient refusal;
- •ASA classification IV or higher;
- •Pre-neoadjuvant chemotherapy;
- •Inability to cooperate (psychiatric abnormalities, impaired consciousness, mental retardation);
- •Comorbidities cannot tolerate home rehabilitation or functional motor examination;
- •Inability to use a smartphone or read Chinese;
- •Average weekly moderate-intensity/high-intensity exercise of >90min/>60min.
Arms & Interventions
Internet+wearble device prehabilitation model
Pre-rehabilitation components include smoking cessation, aerobic training, anaerobic exercise, nutritional optimization and psychological support.
"Internet+" group using online application + wearable device management model
Intervention: Internet + wearble device multimodal prehabilitation (Behavioral)
traditional prehabilitation model
The traditional prehabilitation group used the traditional management model of preoperative education + paper records + regular weekly reminders from healthcare professionals
Intervention: traditional multimodal prehabilitation (Behavioral)
Outcomes
Primary Outcomes
6 minute walking test distance, 6MWD
Time Frame: About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery
Using 6MWD as the primary assessment of patients' perioperative functional status and the primary endpoint of the study, patients were evaluated at enrollment, before surgery, and 30 days after surgery, respectively.
Secondary Outcomes
- postoperative complication(30 days after surgery)
- Quality of Recovery-15（QOR-15）(About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery)
- pulmonary function(About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery)
- grip(About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery)
- Hospital Anxiety and Depression Scale（HADS）(About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery)
- NRS2002 Nutritional Risk Screening(About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery)
- World Health Organization Disability Assessment Schedule 2.0（WHODAS 2.0）(About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery)
- Length of hospitalization(About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery)
Investigators
ZIJIA LIU
associate chief physician
Peking Union Medical College Hospital