Ignite Creation Date:
2024-05-06 @ 2:58 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04485611
Status:
COMPLETED
Last Update Posted:
2024-05-09
First Post:
2020-07-02
Brief Title:
Prehabilitation of Veterans With Exercise and Nutrition
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Prehabilitation of Veterans With Exercise and Nutrition PREVENT
Status:
COMPLETED
Status Verified Date:
2024-05
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:
PREVENT
Brief Summary:
The goal of VAs RRD office is to maximize functional recovery This proposal will allow the investigators to test an intervention that combines the fundamentals of Physical Medicine and Rehabilitation with state-of-the-art nutritional support and innovations in care such as telehealth and the use of activity trackers to optimize patients before high-risk surgery This intervention has the potential to not only reduce complications and hospital readmissions but also to maximize functional recovery and quality of life for thousands of Veterans undergoing high-risk surgery every year Furthermore the proposal is the first step in the design and implementation of prehabilitative services for Veterans living in rural areas and those with inadequate support or transportation
Detailed Description:
Approximately half a million operations are performed each year in VA hospitals across the country Veterans undergoing high-risk surgery have a 1 in 5 chance of suffering complications a 1 in 10 chance of being readmitted to the hospital within 30 days and a 1 in 50 chance of dying within 30 days Long-term survival is significantly reduced for those patients who have perioperative complications even if they survive to leave the hospital
Low fitness and poor functional status are among the strongest predictors of postsurgical complications Prehabilitation takes advantage of the weeks leading up to surgery in order to improve fitness mobility and nutrition in preparation for the upcoming surgical stress Indeed prehabilitation has been shown to improve fitness and reduce complications and quality of life in high-risk surgical patients The most effective prehabilitation programs combine exercise plus nutritional support are multimodal and provide exercise that is supervised and individualized ensuring the appropriate exercise intensity and increasing it gradually according to improvements in fitness and strength Most supervised prehabilitation programs are facility-based but travel time distance and transportation limit participation Unfortunately home-based prehabilitation programs have shown small effect sizes and low compliance rates likely because adequate training intensity is required in programs of such short duration which is often not achieved with unsupervised home-based programs A prehabilitation program that is delivered using telehealth would be ideal because it combines accessibility with supervision encouraging compliance and ensuring adequate training intensity but such programs do not currently exit within the VA
The investigators aim to determine the feasibility acceptability safety and effect size estimates for outcomes of interest of a short-term 3-4 week multimodal prehabilitation intervention that is supervised and individualized yet is delivered at home using telehealth technology The exercise program will consist of 3 days of supervised telehealth exercise sessions per week consisting of moderate intensity aerobic training and resistive and functional training Nutritional support will consist of tailored nutritional advice whey protein supplementation and multivitamin and vitamin D supplementation during prehabilitation and following hospital discharge for 6 weeks Compliance with the interventions will be enhanced by daily automated text messages using the VA Annie App In addition participants will be contacted weekly in order to identify problems with compliance and to provide counseling Post-operative exercise sessions will resume as early as 1 week postoperatively and progressed as allowed according to the type of surgery Text messages and weekly calls will also resume postoperatively until the 6-week follow-up visit to encourage progressive increases in unsupervised physical activity and nutritional support Objective physical activity data will be collected using physical activity trackers which patients will wear from the time of enrollment until the 6-week postoperative follow-up visit Follow-up will continue for a total of 6 months postoperatively
The main outcomes of interest include feasibility acceptance rates acceptability compliance rates and safety number of adverse events The investigators will also measure changes in fitness nutritional state anxiety and depression and health-related quality of life throughout the study period in order to estimate effect sizes which will inform a future randomized trial The proposed work combines several innovations in the delivery of exercise and nutrition and applies them to the perioperative high-risk population for the first time It constitutes the first step toward the study of a multimodal tele-prehabilitation program on postoperative and long-term outcomes following high-risk surgery
Low fitness and poor functional status are among the strongest predictors of postsurgical complications Prehabilitation takes advantage of the weeks leading up to surgery in order to improve fitness mobility and nutrition in preparation for the upcoming surgical stress Indeed prehabilitation has been shown to improve fitness and reduce complications and quality of life in high-risk surgical patients The most effective prehabilitation programs combine exercise plus nutritional support are multimodal and provide exercise that is supervised and individualized ensuring the appropriate exercise intensity and increasing it gradually according to improvements in fitness and strength Most supervised prehabilitation programs are facility-based but travel time distance and transportation limit participation Unfortunately home-based prehabilitation programs have shown small effect sizes and low compliance rates likely because adequate training intensity is required in programs of such short duration which is often not achieved with unsupervised home-based programs A prehabilitation program that is delivered using telehealth would be ideal because it combines accessibility with supervision encouraging compliance and ensuring adequate training intensity but such programs do not currently exit within the VA
The investigators aim to determine the feasibility acceptability safety and effect size estimates for outcomes of interest of a short-term 3-4 week multimodal prehabilitation intervention that is supervised and individualized yet is delivered at home using telehealth technology The exercise program will consist of 3 days of supervised telehealth exercise sessions per week consisting of moderate intensity aerobic training and resistive and functional training Nutritional support will consist of tailored nutritional advice whey protein supplementation and multivitamin and vitamin D supplementation during prehabilitation and following hospital discharge for 6 weeks Compliance with the interventions will be enhanced by daily automated text messages using the VA Annie App In addition participants will be contacted weekly in order to identify problems with compliance and to provide counseling Post-operative exercise sessions will resume as early as 1 week postoperatively and progressed as allowed according to the type of surgery Text messages and weekly calls will also resume postoperatively until the 6-week follow-up visit to encourage progressive increases in unsupervised physical activity and nutritional support Objective physical activity data will be collected using physical activity trackers which patients will wear from the time of enrollment until the 6-week postoperative follow-up visit Follow-up will continue for a total of 6 months postoperatively
The main outcomes of interest include feasibility acceptance rates acceptability compliance rates and safety number of adverse events The investigators will also measure changes in fitness nutritional state anxiety and depression and health-related quality of life throughout the study period in order to estimate effect sizes which will inform a future randomized trial The proposed work combines several innovations in the delivery of exercise and nutrition and applies them to the perioperative high-risk population for the first time It constitutes the first step toward the study of a multimodal tele-prehabilitation program on postoperative and long-term outcomes following high-risk surgery
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 728745 | OTHER_GRANT | VA RRD | None |