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Trial Title:
Multidisciplinary Prehabilitation Management Pathway and Network Platform Construction
NCT ID:
NCT06573788
Condition:
Lung Cancer
Prehabilitation
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Prospective randomized clinical trial
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.
Intervention:
Intervention type:
Behavioral
Intervention name:
Internet + wearble device multimodal prehabilitation
Description:
Use the Prehabilitation Learning Platform to learn what to do and follow along with the
videos for follow up exercises
Arm group label:
Internet+wearble device prehabilitation model
Intervention type:
Behavioral
Intervention name:
traditional multimodal prehabilitation
Description:
The researchers used a prehabilitation manual to explain to subjects what they needed to
do, and the patients went home and practiced on their own, recording the exercises daily
Arm group label:
traditional prehabilitation model
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
September 1, 2024
Completion date:
March 31, 2026
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06573788