Prehabilitation of Veterans With Exercise and Nutrition

Frailty Clinical Trial

— PREVENT  

Official title:

Prehabilitation of Veterans With Exercise and Nutrition (PREVENT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04485611
• Other study ID #: F3468-P
• Secondary ID: 728745
• Status: Completed
• Phase: N/A
• Start date: May 27, 2021
• Est. completion date: March 29, 2024

Study information

• Verified date: May 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 29, 2024
• Est. primary completion date: March 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Frailty

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Durham VA Medical Center, Durham, NC	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility, measured as acceptance rate	Acceptance rate will be calculated as the number of enrolled divided by the number of eligible patients.	24 weeks
Primary	Acceptability, measured as compliance rate	For the exercise intervention, the investigators will measure the percentage of patients completing 75% of sessions divided by the number of enrolled patients. For the nutritional intervention, compliance will be measured by the percentage of patients with 75% adherence to protein intake goal, as assessed using the text message-based nutrition diary, lids returned, and 24-hour recall administered during the weekly telephone call.	24 weeks
Primary	Safety, measured as the number of adverse events during exercise.	A significant injury or medical event is defined as an event that causes the participant to seek attention from a health professional or limits their activities of daily living for at least two days.	12 weeks
Primary	Reasons for enrollment/non-enrollment	The investigators will evaluate reasons for enrollment/non-enrollment in the program using patient interviews and semi-structured questionnaires.	24 weeks
Secondary	Physical function - Aerobic endurance	Aerobic endurance will be assessed using the 2-minute step test (2MST). The 2MST requires that tested individuals march in place as fast as possible for 2 minutes while lifting the knees to a height midway between their patella and iliac crest when standing (typically marked on the wall using tape). Scoring involves counting the number of times the right knee reaches the tape level in two minutes and comparing against normative values for age. A higher number denotes better aerobic endurance.	6 months
Secondary	Quality of Life	Pre to post intervention changes in QOL as measured by the SF-36 questionnaire	6 months
Secondary	Anxiety and Depression	Pre to post intervention changes in anxiety and depression as measured by the Hospital Anxiety & Depression Scale (HADS) questionnaire	6 months
Secondary	Physical function - Lower extremity strength and balance	Lower extremity strength and balance will be assessed using the 5-repetition sit-to-stand test (5XSST). The 5XSST assesses functional lower extremity strength, transitional movements, balance, and fall risk in older adults. The 5XSST scoring is based on the amount of time (to the nearest decimal in seconds) a patient is able to transfer from a seated to a standing position and back to sitting five times. The lower the time to complete the test the better the outcome of the test. The age matched norms score are 11.4 seconds for 60-69 years age groups and 12.6 seconds and 14.8 seconds for 70-79 and 80-89 years of age group ,respectively.	3 months