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Prehabilitation of Veterans With Exercise and Nutrition (PREVENT)

Primary Purpose

Frailty

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Supervised aerobic + resistance training and nutritional support
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Frailty focused on measuring frailty, exercise training, telemedicine, nutritional support

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Durham VA Medical Center, Durham, NCRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prehabilitation

Arm Description

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

Outcomes

Primary Outcome Measures

Feasibility, measured as acceptance rate
Acceptance rate will be calculated as the number of enrolled divided by the number of eligible patients.
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.
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.
Reasons for enrollment/non-enrollment
The investigators will evaluate reasons for enrollment/non-enrollment in the program using patient interviews and semi-structured questionnaires.

Secondary Outcome Measures

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.
Quality of Life
Pre to post intervention changes in QOL as measured by the SF-36 questionnaire
Anxiety and Depression
Pre to post intervention changes in anxiety and depression as measured by the Hospital Anxiety & Depression Scale (HADS) questionnaire
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.

Full Information

First Posted
July 2, 2020
Last Updated
September 21, 2023
Sponsor
VA Office of Research and Development
Collaborators
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT04485611
Brief Title
Prehabilitation of Veterans With Exercise and Nutrition
Acronym
PREVENT
Official Title
Prehabilitation of Veterans With Exercise and Nutrition (PREVENT)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 27, 2021 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty
Keywords
frailty, exercise training, telemedicine, nutritional support

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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).
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prehabilitation
Arm Type
Experimental
Arm Description
This pilot cohort will undergo an intervention and will be followed for up to 6 months. The study does not include a comparator group.
Intervention Type
Behavioral
Intervention Name(s)
Supervised aerobic + resistance training and nutritional support
Other Intervention Name(s)
Multimodal prehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility, measured as acceptance rate
Description
Acceptance rate will be calculated as the number of enrolled divided by the number of eligible patients.
Time Frame
24 weeks
Title
Acceptability, measured as compliance rate
Description
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.
Time Frame
24 weeks
Title
Safety, measured as the number of adverse events during exercise.
Description
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.
Time Frame
12 weeks
Title
Reasons for enrollment/non-enrollment
Description
The investigators will evaluate reasons for enrollment/non-enrollment in the program using patient interviews and semi-structured questionnaires.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Physical function - Aerobic endurance
Description
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.
Time Frame
6 months
Title
Quality of Life
Description
Pre to post intervention changes in QOL as measured by the SF-36 questionnaire
Time Frame
6 months
Title
Anxiety and Depression
Description
Pre to post intervention changes in anxiety and depression as measured by the Hospital Anxiety & Depression Scale (HADS) questionnaire
Time Frame
6 months
Title
Physical function - Lower extremity strength and balance
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amanda E Wood, PhD
Phone
(253) 583-1652
Email
Amanda.Wood@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atilio Barbeito, MD
Organizational Affiliation
Durham VA Medical Center, Durham, NC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Durham VA Medical Center, Durham, NC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705-3875
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atilio Barbeito, MD
Email
Atilio.Barbeito@va.gov
First Name & Middle Initial & Last Name & Degree
Virginia J Rhodes
Phone
(919) 286-0411
Ext
177632
Email
Virginia.Rhodes@va.gov
First Name & Middle Initial & Last Name & Degree
Atilio Barbeito, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Prehabilitation of Veterans With Exercise and Nutrition

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