Clinical trial NCT06573788: Multidisciplinary Prehabilitation Management Pathway and Network Platform Construction
Official title: Multidisciplinary Prehabilitation Management Pathway and Network Platform Construction
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lung Cancer
Prehabilitation
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized clinical trial
Primary purpose: OTHER

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:

1. Does the Prehabilitation model for Internet+ devices works out?
2. 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.


Eligibility criteria: Inclusion Criteria:

1. Age: 18-75 years;
2. adults with suspected lung cancer proposed for VATS lobectomy/sublobar resection.

Exclusion Criteria:

1. Patient refusal;
2. ASA classification IV or higher;
3. Pre-neoadjuvant chemotherapy;
4. Inability to cooperate (psychiatric abnormalities, impaired consciousness, mental retardation);
5. Comorbidities cannot tolerate home rehabilitation or functional motor examination;
6. Inability to use a smartphone or read Chinese;
7. Average weekly moderate-intensity/high-intensity exercise of \>90min/\>60min.

Primary outcomes:
measure: 6 minute walking test distance, 6MWD
timeFrame: About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery
Secondary outcomes:
measure: Length of hospitalization
timeFrame: About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery
measure: postoperative complication
timeFrame: 30 days after surgery
measure: pulmonary function
timeFrame: About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery
measure: pulmonary function
timeFrame: About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery
measure: pulmonary function
timeFrame: About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery
measure: pulmonary function
timeFrame: About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery
measure: grip
timeFrame: About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery
measure: NRS2002 Nutritional Risk Screening
timeFrame: About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery
measure: Hospital Anxiety and Depression Scale（HADS）
timeFrame: About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery
measure: Quality of Recovery-15（QOR-15）
timeFrame: About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery
measure: World Health Organization Disability Assessment Schedule 2.0（WHODAS 2.0）
timeFrame: About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Peking Union Medical College Hospital
name: Zijia Liu
role: PRINCIPAL_INVESTIGATOR
References: