Clinical trial NCT04485611: Prehabilitation of Veterans With Exercise and Nutrition
Official title: Prehabilitation of Veterans With Exercise and Nutrition (PREVENT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Keywords: frailty
exercise training
telemedicine
nutritional support
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Duke University
First posted: 2020-07-24
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The intervention will consist of a period of supervised multimodal prehabilitation prior to high-risk surgery (aerobic and resistance training sessions 3 times/week plus nutritional support) delivered using telehealth technology, and similar sessions resuming after surgery and for up to 6 weeks (rehabilitation).
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Feasibility, measured as acceptance rate
timeFrame: 24 weeks
measure: Acceptability, measured as compliance rate
timeFrame: 24 weeks
measure: Safety, measured as the number of adverse events during exercise.
timeFrame: 12 weeks
measure: Reasons for enrollment/non-enrollment
timeFrame: 24 weeks
Secondary outcomes:
measure: Physical function - Aerobic endurance
timeFrame: 6 months
measure: Quality of Life
timeFrame: 6 months
measure: Anxiety and Depression
timeFrame: 6 months
measure: Physical function - Lower extremity strength and balance
timeFrame: 3 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Atilio Barbeito, MD
role: PRINCIPAL_INVESTIGATOR
References: