Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06215326
Status:
RECRUITING
Last Update Posted:
2024-03-01
First Post:
2023-12-20
Brief Title:
Short-term Effects of Preoperative Exercise in Moderate-to-high Perioperative Risk Lung Cancer Patients
Sponsor:
Guangdong Provincial Peoples Hospital
Organization:
Guangdong Provincial Peoples Hospital
Study Overview
Official Title:
Short-term Effects of Preoperative Exercise in Moderate-to-high Perioperative Risk Lung Cancer PatientsPRE-EXELUCA a Multicenter Prospective Randomized Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRE-EXELUCA
Brief Summary:
The goal of this clinical trail is to compare the effects of preoperative exercise training of different intensities on short-term cardiorespiratory function and postoperative outcomes in patients scheduled for lung resections
Detailed Description:
Guangdong Provincial Peoples Hospital will be the lead center with an additional 3 hospitals designated as satellite centers for the study To sum up these centers will recruit a total of 100 consenting patients Following informed consent and baseline testing participants will be randomized into one of the three groups in a 211 ratio MICT HIIT or usual care UC
Participants in the MICT and HIIT groups perform a total of 12 sessions of supervised exercise training while participants randomized to the UC group receive no extra rehabilitation or physical activity All participants are followed-up at the completion of the intervention periodPrimary outcomes including cardiopulmonary exercise function and pulmonary function will be measured at diagnosis lung cancer patients scheduled for surgical treatment V1 baseline V2 and post-intervention V3 The baseline assessment includes medical history and examination To lessen the psychological burden of the study on the patients the baseline examination phase could not be repeated if the examinations had been completed during the screening phase and the date of completion was within 7 days prior to enrollment The patients postoperative complications chest tube removal time and hospital length of stay LOS will be recorded on the day of discharge V4 Patient-reported outcomes PROs will be measured at baseline V2 post-intervention V3 day of discharge V4 1 month postoperative V5 and 3 months postoperative V6 with ongoing follow-up Participant blood samples and diaphragm ultrasound will be retained at baselineV2 and post-intervention V3 as available Postoperative deaths will be followed up by telephone on the day of discharge V4 3 months postoperatively V6 1 year postoperatively V7 3 years postoperatively V8 and 5 years postoperatively V9
Participants in the MICT and HIIT groups perform a total of 12 sessions of supervised exercise training while participants randomized to the UC group receive no extra rehabilitation or physical activity All participants are followed-up at the completion of the intervention periodPrimary outcomes including cardiopulmonary exercise function and pulmonary function will be measured at diagnosis lung cancer patients scheduled for surgical treatment V1 baseline V2 and post-intervention V3 The baseline assessment includes medical history and examination To lessen the psychological burden of the study on the patients the baseline examination phase could not be repeated if the examinations had been completed during the screening phase and the date of completion was within 7 days prior to enrollment The patients postoperative complications chest tube removal time and hospital length of stay LOS will be recorded on the day of discharge V4 Patient-reported outcomes PROs will be measured at baseline V2 post-intervention V3 day of discharge V4 1 month postoperative V5 and 3 months postoperative V6 with ongoing follow-up Participant blood samples and diaphragm ultrasound will be retained at baselineV2 and post-intervention V3 as available Postoperative deaths will be followed up by telephone on the day of discharge V4 3 months postoperatively V6 1 year postoperatively V7 3 years postoperatively V8 and 5 years postoperatively V9
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None