Prehabilitation of Veterans With Exercise and Nutrition

NCT ID: NCT04485611

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-27
• Study Completion Date: 2024-03-29

Brief Summary

The goal of VA's RR&D 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.

Conditions

Frailty

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Prehabilitation

This pilot cohort will undergo an intervention and will be followed for up to 6 months. The study does not include a comparator group.

Group Type: EXPERIMENTAL

Supervised aerobic + resistance training and nutritional support

Intervention Type: BEHAVIORAL

The intervention will consist of individualized exercise training delivered remotely using VA telehealth technology, combined with nutritional support consisting of tailored nutritional advice, protein supplementation, multivitamin and vitamin D supplements\]\]. Adherence to the intervention will be enhanced by use of automated text messages and monitored using activity trackers.

Interventions

Supervised aerobic + resistance training and nutritional support

The intervention will consist of individualized exercise training delivered remotely using VA telehealth technology, combined with nutritional support consisting of tailored nutritional advice, protein supplementation, multivitamin and vitamin D supplements\]\]. Adherence to the intervention will be enhanced by use of automated text messages and monitored using activity trackers.

Intervention Type: BEHAVIORAL

Other Intervention Names

Multimodal prehabilitation

Eligibility Criteria

Inclusion Criteria

• Scheduled for high-risk surgery
• Time from assessment to surgery 21 days
• Age 50 years
• English speaking
• 5RSTS time >11 sec and/or TMST score 25% percentile for gender/age

Exclusion Criteria

• A score of <21 (high school) or <20 (less than high school) on the Montreal Cognitive Assessment (MoCA)
• Dementia diagnosis
• Inability to complete physical function assessment
• ASA categories 4 and 5
• Living in skilled nursing facility
• No access to a telephone
• Advanced chronic kidney disease (KDIGO stage 4 and 5)

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Atilio Barbeito, MD

Role: PRINCIPAL_INVESTIGATOR

Durham VA Medical Center, Durham, NC

Locations

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

728745

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

F3468-P

Identifier Type: -

Identifier Source: org_study_id