Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06633614
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
PREhabilitation of Frail Elderly PAtients Undergoing MajoR SurgEry At HOME PREPARE-HOME Using Smart Wearables
Sponsor:
None
Organization:
None
Study Overview
Official Title:
PREhabilitation of Frail Elderly PAtients Undergoing MajoR SurgEry At HOME PREPARE-HOME Using Smart Wearables a Prospective Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREPAREHOME
Brief Summary:
The goal of this clinical trial is to evaluate whether a prehabilitation program using wearable technology can improve physical function and postoperative outcomes in elderly patients 65 years or older undergoing major elective non-cardiac surgery The main questions it aims to answer are
Does the prehabilitation program improve physical function as measured by the 6-minute walk test 6MWT from baseline to pre-surgery Does the prehabilitation program reduce postoperative complications and enhance recovery Researchers will compare participants who receive the prehabilitation program with wearable technology intervention group to those receiving standard preoperative care control group to see if the intervention results in greater improvements in physical function and postoperative outcomes
Participants will
Follow a personalized exercise program monitored remotely via telemedicine Wear a Fitbit Aspire 3 device to track vital signs such as heart rate and physical activity
Undergo assessments of physical function and quality of life before surgery
Does the prehabilitation program improve physical function as measured by the 6-minute walk test 6MWT from baseline to pre-surgery Does the prehabilitation program reduce postoperative complications and enhance recovery Researchers will compare participants who receive the prehabilitation program with wearable technology intervention group to those receiving standard preoperative care control group to see if the intervention results in greater improvements in physical function and postoperative outcomes
Participants will
Follow a personalized exercise program monitored remotely via telemedicine Wear a Fitbit Aspire 3 device to track vital signs such as heart rate and physical activity
Undergo assessments of physical function and quality of life before surgery
Detailed Description:
This clinical trial aims to investigate the effectiveness of a prehabilitation program using wearable technology to improve physical function and postoperative outcomes in elderly patients undergoing major elective non-cardiac surgery The intervention group will receive a comprehensive preoperative rehabilitation program swSEP that includes personalized exercise regimens monitored via telemedicine and a wearable device Fitbit Aspire 3 to track key physiological metrics such as heart rate physical activity and sleep patterns The exercise program will consist of three components strength training aerobic exercises and flexibility exercises These sessions will be conducted three times per week with adjustments made by the physiotherapist based on the participants progress and vital sign responses
Participants will be monitored closely through telemedicine check-ins twice per week to ensure adherence to the exercise program address any challenges and make modifications to the regimen as needed In addition all participants will undergo baseline functional assessments including the 6-minute walk test 6MWT 30-second sit-to-stand test 30sSTS handgrip strength HGS and maximal inspiratory pressure MIP as well as nutritional and quality of life assessments using the MUST score and EQ-5D-5L questionnaire These assessments will be repeated 1-3 days before surgery to evaluate any improvements in physical function
The control group uSEP will receive standard preoperative care which includes physiotherapy education and a home-based exercise booklet but will not be provided with a wearable device or telemedicine supervision Both groups will be monitored for postoperative outcomes including the incidence of complications classified by the Clavien-Dindo system hospital length of stay ICU admissions and hospital readmissions Health-related quality of life HRQoL will also be measured at multiple time points
Exploratory analyses will include postoperative recovery and resumption of physical activity at 12 weeks post-surgery as well as heart rate variability HRV data from the wearable devices to assess physiological responsiveness to the prehabilitation program and its potential predictive value for postoperative outcomes A qualitative interview study will be conducted concurrently to explore the barriers and facilitators of home-based prehabilitation from the perspectives of both patients and healthcare providers
Participants will be monitored closely through telemedicine check-ins twice per week to ensure adherence to the exercise program address any challenges and make modifications to the regimen as needed In addition all participants will undergo baseline functional assessments including the 6-minute walk test 6MWT 30-second sit-to-stand test 30sSTS handgrip strength HGS and maximal inspiratory pressure MIP as well as nutritional and quality of life assessments using the MUST score and EQ-5D-5L questionnaire These assessments will be repeated 1-3 days before surgery to evaluate any improvements in physical function
The control group uSEP will receive standard preoperative care which includes physiotherapy education and a home-based exercise booklet but will not be provided with a wearable device or telemedicine supervision Both groups will be monitored for postoperative outcomes including the incidence of complications classified by the Clavien-Dindo system hospital length of stay ICU admissions and hospital readmissions Health-related quality of life HRQoL will also be measured at multiple time points
Exploratory analyses will include postoperative recovery and resumption of physical activity at 12 weeks post-surgery as well as heart rate variability HRV data from the wearable devices to assess physiological responsiveness to the prehabilitation program and its potential predictive value for postoperative outcomes A qualitative interview study will be conducted concurrently to explore the barriers and facilitators of home-based prehabilitation from the perspectives of both patients and healthcare providers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None