Prehabilitation of Veterans With Exercise and Nutrition (PREVENT)
Phase: NA
Conditions: Frailty
Sponsor: VA Office of Research and Development

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Prehabilitation of Veterans with Exercise and Nutrition 
(PREVENT) 
 
 
Principal Investigator: 
        Atilio Barbeito, M.D., M.P.H 
 
 
 
 
Study Number: 
        TBD 
 
 
 
 
Version Date: 
        8 June 2021 
 
 
 
 
Sponsor/Funding Source: 
        VA Rehabilitation Research and 
 
        Development (RR&D) Service 
 
 
 

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Table of Contents 
 
TITLE PAGE .................................................................................................................................... 1 
LIST OF ABBREVIATIONS ............................................................................................................ 4 
1.0 
PURPOSE............................................................................................................................. 4 
2.0 
BACKGROUND AND SIGNIFICANCE ............................................................................... 5 
3.0 
DESIGN ............................................................................................................................... 6 
4.0 
RISK/BENEFIT ASSESSMENT ...........................................................................................7 
4.1 
Risk Assessment ................................................................................................................7 
4.2 
Benefit Assessment ...........................................................................................................7 
5.0 
SELECTION OF SUBJECTS .................................................................................................7 
5.1 
Study Population .............................................................................................................. 8 
5.2 
Inclusion and Exclusion Criteria ...................................................................................... 8 
5.2.1 
Inclusion Criteria ...................................................................................................... 8 
5.2.2 
Exclusion Criteria ..................................................................................................... 8 
5.3 Inclusion of Women and Minorities ..................................................................................... 8 
6.0 
SUBJECT RECRUITMENT ................................................................................................. 8 
7.0 
CONSENT PROCESS ........................................................................................................... 9 
7.1 
Screening .......................................................................................................................... 9 
7.2 
Eligible Patients ............................................................................................................... 9 
8.0 
STUDY INTERVENTIONS .................................................................................................10 
8.1 
Screening Procedures ......................................................................................................10 
8.2 
Study Procedures ............................................................................................................10 
8.2.1 
Exercise Program ..................................................................................................... 11 
8.2.2 
Nutritional Support Program .................................................................................. 11 
8.2.3 
Automated Text Messages ....................................................................................... 12 
9.0 
ADVERSE EVENTS ............................................................................................................ 14 
10.0 
COSTS AND/OR PAYMENTS TO SUBJECTS ................................................................ 14 
11.0 
DATA AND SAFETY MONITORING .............................................................................. 14 
12.0 
WITHDRAWAL OF PARTICIPANTS ............................................................................. 15 
13.0 
DATA ANALYSIS AND STATISTICAL CONSIDERATIONS.......................................... 15 
14.0 
PRIVACY, CONFIDENTIALITY, AND INFORMATION SECURITY ............................. 15 
14.1 
Lists of Data Reviewed and/or Collected for Screening/Recruitment and Conduction 
of Study: ..................................................................................................................................... 15 

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14.2 
Data and/or Specimen Acquisition: ............................................................................ 16 
14.3 
Level of Data: ............................................................................................................... 17 
14.4 
Location of Data and/or Specimens, and Data Retention Plan: ................................. 17 
14.4.1 
Data and/or Specimen Location .......................................................................... 17 
14.4.2 
Data Retention Plan ............................................................................................. 18 
14.5 
Data Access and Data Recipients: ............................................................................... 18 
14.6 
Data and/or Specimen Transportation and/or Transmission for all data .................. 19 
14.7 
Risk Mitigation Strategies: ......................................................................................... 20 
14.8 
Suspected Loss of VA Information: ............................................................................. 21 
14.9 
Reporting of Results: ................................................................................................... 21 
14.10 
Future Use of Data: ..................................................................................................... 21 
14.11 
Use of Mail Merge Technology .................................................................................... 21 
14.12 
Use of Non-Standard Software .................................................................................... 21 
14.13 
Use of Cloud Computing Services .............................................................................. 22 
15.0 
REFERENCES ................................................................................................................ 23 
 
 
 

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List of Abbreviations 
 
PREVENT 
Prehabilitation of Veterans with Exercise and Nutrition 
RR&D  
Rehabilitation Research and Development Service 
KDIGO 
Kidney Disease Improving Global Outcomes 
GFR 
 
Glomerular Filtration Rate 
PAEC  
Pre-Anesthesia Evaluation Clinic 
POSH  
Preoperative Optimization of Senior Health (Clinic) 
5RSTS  
Five Repetition Sit-to-Stand 
TMST  
Treadmill Stress Testing 
MoCA  
Montreal Cognitive Assessment 
ASA 
 
American Society of Anesthesiologists 
VCM  
Virtual Care Management 
RPE 
 
Rate of Perceived Exertion 
 

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1.0 
Purpose 
 
The goal of VA’s RR&D office is to maximize functional recovery. Considering that goal, our 
proposal allows us 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 to optimize patients before high-risk surgery. This intervention has the potential not 
only to 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. 
 
 
2.0 
Background and Significance 
 
Approximately half a million operations are performed each year in VA hospitals across the 
country4. 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 days4. Long-term survival is significantly reduced for those patients who have 
perioperative complications, even if they survive to leave the hospital5. 
 
Low fitness and poor functional status are among the strongest predictors of postsurgical 
complications1,2. Prehabilitation takes advantage of the weeks leading up to surgery in order to 
improve fitness, mobility and nutrition in preparation for the upcoming surgical stress13. Indeed, 
prehabilitation has been shown to improve fitness, reduce complications, and improve quality of 
life in high-risk surgical patients7,9,12. The most effective prehabilitation programs combine 
exercise with nutritional support (are multimodal).  They provide exercise that is supervised and 
individualized and ensure that exercise intensity is appropriate and escalated according to 
improvements in fitness and strength. Most supervised prehabilitation programs are facility-
based, with participation limited by travel time, distance, and transportation10. Unfortunately, 
home-based prehabilitation programs have shown small effect sizes and low compliance rates, 
likely because the intensity required in programs of such short duration is often not achieved 
with such unsupervised programs14-16. 
 
The goal of prehabilitation is to enhance fitness and physical function in anticipation of a 
forthcoming physiological stress9. One of the main components of prehabilitation is a structured 
exercise protocol that typically includes aerobic and resistance exercise. By repeatedly exposing 
the body to physiologic stress, physical activity stimulates muscle protein synthesis resulting in 
improved objective markers of physical fitness and improved strength10-13. Nutrition is another 
key component of prehabilitation because it works synergistically with exercise14. It is generally 
accepted that exercise provides the primary anabolic stimulus and nutrition potentiates the 
muscle protein response15. Indeed, studies using stable isotopes have shown that exercise 
without provision of adequate protein does not result in optimal gains in muscle accretion16,17. 
After a single session of resistance exercise in healthy individuals, muscle protein breakdown 
and synthesis are both stimulated16. Net protein balance in the muscle (protein synthesis minus 
breakdown)remains negative after exercise until exogenous amino acids are administered16. 
Amino acids stimulate both the synthesis of structural (myofibrillar) muscle protein as well as 
the synthesis of mitochondrial proteins, required for aerobic metabolism and maintenance of 
functional exercise capacity18. 
 
Compliance with prehabilitation programs is extremely variable, with reported rates that vary 
between 16 and 100%13,19-22. Hospital-based prehabilitation programs delivered under direct 

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supervision have the highest compliance rates, yet barriers such as travel time, distance, and 
transportation limit participation 21,23. Previously, we found that rural veterans lack access to 
exercise programs20,22,23. Home-based interventions are attractive but are typically unsupervised 
and associated with reduced compliance rates13,19,21. If applied to prehabilitation, new telehealth 
technologies could address the shortcomings of home-based approaches because they combine 
accessibility with supervision, encouraging compliance while ensuring adequate training 
intensity.  However, this mode of prehabilitation care delivery has not yet been studied in a 
veteran population.  
 
The proposed “tele-supervised” exercise program may allow Veterans living in rural areas and 
lack transportation or are otherwise unable to travel to participate in prehabilitation in 
preparation for an upcoming high-risk operation. These findings are expected to inform the 
design of a larger multicenter trial on the effects of multimodal prehabilitation on surgical 
outcomes and healthcare resource utilization and to foster the widespread adoption of 
multimodal prehabilitation in preoperative optimization of high-risk patients at the Durham 
VAHCS and other VA Health Care Systems. It represents an important step towards providing 
optimal perioperative care for veterans by identifying and improving fitness, physical function, 
and nutrition before surgery in a manner that is not geographically constrained. These 
improvements will contribute to the reduction in health care costs due to decreased 
complications and fewer readmissions following surgery in high-risk patients. 
 
 
3.0 
Design 
 
The objective of this protocol is to determine the feasibility, acceptability, and safety and 
estimate the effect size of a multimodal prehabilitation program that incorporates exercise 
training and nutritional support. The central hypothesis is that a short-duration, individualized 
multimodal prehabilitation intervention administered prior to high-risk surgery is feasible and 
safe at a tertiary VA hospital. 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, and multivitamin and 
vitamin D supplements. Based on local surgical volume, local expertise in the Gerofit and 
telehealth exercise programs in non-surgical populations, and published participation numbers 
and attrition rates, we anticipate that 24 patients can be enroll and safely participate in a home-
based telehealth exercise program plus nutritional support. Adherence to the intervention will 
be encouraged by use of automated text messages. 
 
This is a pilot intervention that combines the most promising elements of prehabilitation along 
with innovations in telehealth delivery to develop a VA patient-centered multimodal 
prehabilitation program with the following specific aims: 
 
• 
To determine the feasibility, acceptability, and safety of a short-term (3-4 week) 
multimodal prehabilitation intervention followed by a 4-6 week period of rehabilitation 
in a cohort of veterans undergoing high-risk surgery. 
• 
To estimate the effect size of a multimodal prehabilitation program for important 
postoperative outcomes (improvements in functional capacity and physical function, 
anxiety/depression, and quality of life). 
 
While aspects of the intervention are novel and the work exploratory, based on available 
evidence, we expect the Cohen’s effect sizes for functional capacity and quality of life to be 
approximately 1.6 and 0.4, respectively.11 

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4.0 
Risk/Benefit Assessment 
 
4.1 
Risk Assessment 
 
There are minimal risks associated with the proposed prehabilitation program. 
Generally, nutrition and exercise are known to improve health. Physical injury or 
discomfort are potential risks and are inherent in any exercise, rehabilitation or 
prehabilitation program. Patients invited to participate will be screened by qualified 
physical therapists as part of the screening evaluation and the inability to complete the 
physical functional assessment will be cause for exclusion.  Also, patients for whom 
physical activity is inappropriate or cognitive impairment affects their ability to consent 
for participation or to successful participate in the exercise program will not be enrolled. 
The team has extensive experience with tele-exercise therapies, including strategies for 
optimizing safety during individual, independent, home-based exercise.  Examples of 
home-based exercises include marching in place, standing (potentially supported) while 
tapping a heel or toes, performing chair stands, and moving a leg or arm against a 
resistance band.  It is entirely self-regulated, and any advancement will be based on self-
reported levels of exertion. 
 
Similarly, the nutrition and vitamin supplementation will be closely monitored by 
nutrition experts and adjusted based on personal telephone check-ins.  Patients with 
advanced kidney disease are excluded from the study and those with renal impairment 
(KDIGO 3a and 3b) will receive reduced protein supplement in accord with ESPEN and 
2012 KDIGO Guidelines.  Renal function will be regularly monitored to ensure there is 
no adverse effect from the nutritional intervention. 
 
Participation in our study poses no additional cost and every effort will be made to 
preserve the privacy and confidentiality of participants.  
 
The similarity of the study interventions to conditions potentially encountered in daily life 
coupled with the measures taken to protect participants from adverse impact create a total risk 
that is minimal.  The types of exercise resemble activities of daily living, especially in that they 
are self-regulated, and no patient will, or could be forced to do something they choose not to do.   
 
4.2 
Benefit Assessment 
 
The benefit of participation in this study is available to both current enrollees and future 
patients. If a monitored prehabilitation program paired with nutrition support is found 
to be feasible, acceptable, and safe, and in the future, adequately powered clinical trials 
found to be effective, significant improvement to perioperative care is possible.  
Furthermore, the telehealth component of this program would facilitate delivery of 
prehabilitation to rural populations and those with limited support or access to 
transportation. 
 
 
5.0 
Selection of Subjects 
 

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5.1 
Study Population 
 
The study population includes frail veterans scheduled to undergo high-risk surgical 
procedures. Veterans scheduled for surgery are evaluated in either the Pre-Anesthesia 
Evaluation Clinic (PAEC) or the Preoperative Optimization of Senior Health (POSH) 
Clinic. We plan to screen veterans who are seen in either clinic and enroll a total of 24 
patients over 2 years. 
 
5.2 
Inclusion and Exclusion Criteria 
 
5.2.1 Inclusion Criteria 
 
• 
Scheduled for high-risk surgery (colorectal, major urologic, hepatibiliary, 
esophageal, thoracic). 
• 
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 
 
 
5.2.2 Exclusion Criteria 
 
• 
Montreal Cognitive Assessment (MoCA) score of <21 (high school 
education) or 20 (< high school education) or Saint Louis University 
Mental Status (SLUMS) score ≤20 
• 
Dementia diagnosis documented in electronic health record 
• 
Inability to complete physical function assessment 
• 
ASA PS categories 4 or 5 
• 
Currently residing in skilled nursing facility 
• 
Lack of access to a telephone 
• 
Advanced chronic kidney disease (KDIGO stage 4 and 5) 
• 
Pregnant at the time of preoperative assessment 
• 
Inability to receive SMS text messages (i.e. does not own a text-enabled 
cellular telephone or tablet) 
 
 
5.3 Inclusion of Women and Minorities 
 
It is the policy of our institution (Durham VAHCS) not to discriminate against any 
patient because of sex, age, ethnicity, race, sexual orientation, or any other attribute. 
Therefore, all patients, including those who are lactating or otherwise of childbearing 
potential (excluding those who are pregnant), who present for surgery at DVHCS and 
meet inclusion/exclusion criteria would be eligible for inclusion in this study.  Given that 
the small size of the cohort, and the focus of this study (feasibility, acceptability, safety, 
and effect size estimation), we do not plan to analyze racial, ethnic or gender groups 
separately. 
 
 
6.0 
Subject Recruitment 
 

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For the purposes of screening, recruiting, and determining eligibility, information will be 
obtained by accessing medical records—a HIPAA Waiver to screen and recruit will be requested. 
Once eligibility is determined, patients will be approached for interest and enrollment during 
their preoperative visit, typically 3-4 weeks prior to surgery. At that time, they will have 
adequate time to consider the study and its benefits and risks, ask questions, and decide if they 
wish to take part. Written informed consent will be obtained by study personnel. 
 
 
7.0 
Consent Process 
 
7.1 
Screening 
 
Patients will be identified in 3 ways:  
(a) Information about this new prehabilitation pilot program will be 
disseminated among our surgical colleagues. Surgeons will be encouraged to 
alert the PREVENT team to any patients being evaluated in the Surgery clinic 
who may be good prehabilitation candidates (frail, undergoing high-risk 
surgery).  
(b) Additionally, a list of proposed cases is currently available in our 
Perioperative Scheduling Software (DSS) and in the VA’s Corporate Data 
warehouse (CDW). This list will be screened periodically to identify potential 
candidates.  
(c) Finally, the list of patients scheduled for evaluation in the PAEC and POSH 
clinics will be reviewed for potential prehabilitation candidates (review of 
Anesthesiology E-Consult or POSH Consult requests).  
 
A HIPAA Waiver for screening purposes will be requested so that eligible participants 
can be identified prior to their PAEC or POSH clinic appointment, if possible ~4 weeks 
or more before their proposed operation.   
 
7.2 
Eligible Patients 
 
When an eligible patient is identified, the day of the PAEC/POSH appointment will be 
determined.  On the day of the clinic visit, the MoCA or SLUMS score, and physical 
function assessments (routinely performed by nursing staff during the clinic visit) will be 
reviewed to establish final eligibility for inclusion in the study, and the research 
coordinator or an investigator will be notified. A study coordinator or investigator will 
review the ICF with each eligible patient, answering all questions or concerns. After a 
review of the ICF, the patient will sign under the supervision of the study personnel and 
a full copy provided to the patient and/or family member. Study personnel may discuss 
the project with their other physicians or family members as needed. 
 
All study personnel have completed the VA Human Subjects Protections and Good 
Clinical Practices training requirement and have experience with the process of 
obtaining and documenting informed consent for research.  Any new study personnel 
who have not had such experience will be trained in several stages, including verbal 
instruction, shadowing consenting visits, VA training modules, and observation by 
qualified personnel. 
 
No study procedures will be performed until after the ICF and HIPAA Authorization 
have been signed and received. Patients with impaired decision-making capability will 

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not be included in this study. Original signed copies of the informed consent form and 
HIPAA Authorization will be kept in our research office (C3011A) while photocopies will 
be provided to patients for their use. 
 
 
8.0 
Study Interventions 
 
8.1 
Screening Procedures 
 
Patient screening will begin with a review of the proposed surgical cases list in DSS and 
CDW, review of Anesthesiology e-consults (PAEC or POSH) and direct surgical referrals 
(as described above in Section 7.1, Screening). A review of the patient’s medical record 
via CPRS on the day of the PAEC/POSH clinic visit will verify that they meet 
inclusion/exclusion criteria.  
 
Patients meeting all inclusion criteria by chart review will then undergo a baseline 
physical function assessment at the time of their PAEC or POSH in-person visit using the 
TMST and 5RSTS tests (as above, part of standard clinic evaluation). Eligible patients 
who consent to participate will then complete a baseline assessment that includes 
anthropometrics, assessment of handgrip strength (HGS), and the PG-GSA, SF-36 and 
HADS questionnaires.   
 
8.2 
Study Procedures 
 
Eligible veterans who consent will enroll in a program of individualized exercise training 
combined with nutritional support during intervening time before and after surgery. 
Study procedures and assessments are outlined in Figure 1 below.  
 
 
 

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Figure 1. Study milestones and assessments 
  
 
Subjects who do not have a smart phone or tablet or who prefer not to use their own 
devices will receive a VA-issued tablet device that they will use to interact with their 
exercise trainer.  They will be asked to download the Annie texting app and aa 
teleconference platform app on either their personal device or the VA-issued device.  The 
VA issued tablets are then the property of the participant and no VA data will be stored 
on them.  Automated text messaging via de VA Annie App will supplement our patients’ 
exercise and nutritional support efforts. 
 
 
 
8.2.1 Exercise Program 
 
The exercise program will consist of a progressive function-based exercise 
program that includes 3 days per week of supervised exercise delivered directly to 
the home using telehealth technology. Exercise prescriptions will be 
individualized to baseline fitness and functional capacity. 
 
Supervised exercise will consist of progressive, rotating, low-impact training 
interspersed with brief rest periods aimed at progressing to 30-minutes of 
moderate intensity aerobic training. Intensity of effort will be titrated to rate-of-
perceived-exertion (RPE), with a target of 4-6 out of a maximum of 10 per 
national guidelines for older adults36,37. Resistance and functional training will be 
included and focus on strengthening the large muscle groups of the core, upper 
and lower extremities, and on maximizing mobility using body weight or 
resistance bands when the participant reaches higher levels of RPE (6-7). 
 
Activities will be constantly monitored and adjusted to increase difficulty but stay 
below the target ceiling of 6-7 RPE. Due to the limited time window, each 
participant will be challenged daily to increase some element of the exercise 
program. A detailed description of the proposed exercise routine is included in 
Appendix 2. Post-operative aerobic and strength exercise will follow similar 
progression beginning as early as 1 week postoperatively. Exercise staff will work 
closely with surgical staff to safely provide exercise progressions given some 
surgeries may contraindicate specific exercises and intensities.   
 
8.2.2 Nutritional Support Program 
 
The nutrition intervention will be directed by a Registered Dietitian Nutritionist 
and will consist of tailored nutritional advice at the time of enrollment, followed 
by high quality protein supplementation individualized for kidney function (1.5 
gm/kg/day for patients with normal kidney function, 1.2 gm/kg per day for 
patients with KDIGO GFR categories G3a and G3b). Patients with KDIGO GFR 
category G4 or G5 will be excluded (see Appendix 3). These recommendations are 
in accordance with current clinical guidelines for nutrition in the perioperative 
period 39,40. 
 

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Multivitamin and vitamin D supplementation will be provided (50% of RDA) 
during prehabilitation and recovery. Preoperatively, a 3-4-week supply of 
supplements will be provided at the PAEC or POSH clinic visits (T1). At the time 
of hospital discharge, participants will be given an additional six-week supply.  
 
8.2.3 Assessments and Supplemental Interventions 
 
Objective physical function assessments will be performed at baseline (T1), 
before surgery (T2), immediately prior to hospital discharge (T3), and then again 
6 weeks postoperatively (T4) by administering the 2MST,5RSTS and HGS 
tests1 either in-person or remotely using telehealth technology (see Table 1 for 
details).  
 
 
The nutritional support intervention will be assessed at baseline (T1), before 
surgery (T2), immediately prior to hospital discharge (T3)and then again 6 weeks 
postoperatively (T4) using anthropometrics, a weekly 24-hour dietary 
recall (via telephone or videoconference, see Appendix 6), and the 
administration of the PG-GSA, a validated nutritional assessment instrument 
(see Table 1 for details).  
 
Both the exercise and nutritional support programs will be supplemented with 
text messages on veterans who own text message-enabled cellphones.  
Messages will be sent daily using the VA Annie App during the prehabilitation 
period (T1 - T2). The purpose of these messages is as a reminder about the timing 
of training sessions, to prompt independent exercise on days between formal 
sessions, to take protein supplement following exercise, and to maintain a 
nutritional diary (see above).  
 
Text messages and weekly telephone or videoconference calls will resume upon 
hospital discharge and extend until the 6-week follow-up visit (T4).  
 
Anxiety, depression, and health-related quality of life will be assessed using the 
HADS and SF-36 questionnaires at baseline (T1), before surgery (T2), 
immediately prior to hospital discharge (T3), and 6 and 24 weeks postoperatively 
(T4 and T5, respectively). These questionnaires will be administered either in 
person or via telephone or videoconference.  
 
Details and timelines for each of these assessment instruments are described in 
Table 1.  
 
Table 1. Assessments of physical function & mobility, nutrition, anxiety/depression, and 
health-related quality of life 
Domain 
Measure 
Details 
When 
Collected 
Screening Measures 
 
Medical History 
A chart review will be conducted for every potential participant to 
assess eligibility (see criteria above) and to document surgery 
type. 
Baseline 
(T1) 
 
1 The HGS test will only be administered when the assessment is conducted in person 

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Cognition 
Participants must have a score of ≥20 (< high school education) 
or ≥21 (high school or more) on the MoCA or a score of ≥21 on 
the SLUMS test and able to do ADLs to qualify for participation 
in this study.41 
T1 
Outcome Measures  
 
Demographics 
Standard demographic information will be gathered via self-
report and physical examination at baseline to describe the study 
sample. 
T1 
Physical 
Function & 
Mobility 
5RSTS 
The five repetition sit-to-stand test (5RSTS) is widely used as an 
indicator of lower limb strength among older adults.31 The test is 
easy to administer and has good to high test-retest reliability.42 
In a meta-analysis conducted to generate normative values for 
this test, patients older than 60 years of age exceeding 11.4 sec 
were considered to have worse than average performance.31 
T1, T2, T3, 
T4 
TMST 
The two-minute step test (TMST) requires that 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. The performance on the test is defined as the number 
of right-side steps of the criterion height completed in 2 
minutes.35 
T1, T2, T3, 
T4 
HGS 
Handgrip strength can be quantified by measuring the amount of 
static force that the hand can squeeze around a dynamometer. 
Low handgrip strength is a clinical marker of poor mobility and a 
better predictor of clinical outcomes than low muscle mass. Grip 
strength may also be used as a reliable surrogate for more 
complicated measures of muscle strength in the lower arms or 
legs. 
T1, T2, T3, 
T4 
Nutrition 
Anthropo- 
metrics 
Anthropometric measurements, including body mass index 
(BMI, weight in kilograms over the square of height in meters), 
mid-upper arm circumference, upper thigh circumference, waist 
circumference, hip circumference, and waist-to-hip ratio. 
T1, T2, T3, 
T4 
PG-SGA 
The PG-SGA includes assessments of weight, food intake, and 
nutrition impact symptoms.43 The PG-SGA provides a global 
rating nutritional diagnosis (A, B, or C) and a continuous 
numerical score (1 to 30) for intervention triage. The Subjective 
Global Assessment (SGA), included in the PG-SGA, has also been 
applied and validated in predicting length of stay, postoperative 
complications, and mortality.44 
T1, T2, T3, 
T4 
24-hour 
recall 
Under the guidance of the Registered Dietitian Nutritionist, the 
study Physiologist will administer 24-hour dietary recalls once a 
week to assess compliance. This will be done using the USDA 5-
step Multiple Pass Method (Conway et al 2003) to capture 
detailed information about all foods and beverages consumed by 
the participant in the past 24 hours. The USDA multiple-pass 
method for dietary recall consists of five steps: (a) the quick list, 
which is an uninterrupted listing by the subject of foods and 
beverages consumed; (b) the forgotten foods list, which queries 
the subject on categories of foods that have been documented as 
frequently forgotten; (c) a time and occasion at which foods were 
consumed; (d) the detail cycle, which elicits descriptions of foods 
and amounts eaten aided by the interactive use of the USDA 
Weekly 
phone calls 

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Food Model Booklet and measuring guides; and finally (e) the 
final probe review. 
The USDA Food Model Booklet (9) was used to assist in portion-
size estimation of consumed foods. It has eight sections: (a) the 
forgotten foods list, (b) glasses and mugs, (c) bowls, (d) mounds, 
(e) circles, (f) grid and thickness blocks, (g) wedges, and (h) 
shapes and chicken pieces. 
Health-
related 
Quality of 
Life 
SF-36 
The 36-Item Short-Form Health Survey (SF-36) contains 36 
items that are scored as 8 multi-item scales, namely vitality, 
physical functioning, bodily pain, general health perceptions, 
physical role functioning, emotional role functioning, social role 
functioning, and mental health.45 
T1, T4, T5 
Anxiety and 
Depression 
HADS 
Hospital Anxiety and Depression Scale (HADS) is a 
questionnaire involving statements relevant to generalized 
anxiety and depression.46 Each item is answered on a four-point 
(0–3) response category, and the possible scores range from 0 to 
21 for anxiety and 0 to 21 for depression.  
T1, T2, T3, 
T4, T5 
 
 
9.0 
Adverse Events 
 
Because the intervention closely resembles daily activities and is so closely monitored, we expect 
a low rate of adverse events. All adverse events will be reported per Durham VAMC 
requirements. All Serious, Unanticipated and Related Adverse Events will be reported to IRB 
within five business days of a member of the study team learning of the event. All other adverse 
events will be reported at the time of continuing review. Should any incident such as theft or loss 
of data, unauthorized access of sensitive data, or non-compliance with security controls occur, it 
will be immediately reported according to VA policy. All incidents regarding information 
security/privacy incidents will be reported to the ISO and PO within one hour of report. 
 
 
10.0 Costs and/or Payments to Subjects 
 
Participants will be reimbursed $50 for each in-person clinic visit they make for purposes of 
study procedures (range $100-$200).  The initial preoperative visit and the 6-week 
postoperative visit for all participants with an optional second preop visit immediately prior to 
surgery if the T2 assessment cannot be performed on the day of surgery and at T5 if the 
assessments cannot be performed over the telephone.   
 
 
11.0 
Data and Safety Monitoring 
 
Hardcopy documents, including those containing PHI, will be stored in folders and binders and 
kept inside a locked cabinet in the Anesthesia Research Office (C3011A), and are accessible to 
research personnel only. Electronic data will be stored on secure VA servers accessible only to 
study personnel [S:\Anesthesia Research\Atilio Barbeito\PREVENT\Data]. Study data will be 
reviewed as patients are enrolled and any member of the study team may review source 
documents or data at any time. Protocol deviations, data discrepancies, errors, or missing 
information will be resolved and/or reported per DVAHCS and IRB policy. 
 
 

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12.0 
Withdrawal of Participants 
 
Participants will be withdrawn from the study if any of the following occur: 
 
• 
Withdrawal of study consent  
• 
Inability to continue with the exercise or nutritional support program for any reason 
• 
At the Principal Investigator’s discretion 
 
If a participant is withdrawn, follow-up for the purposes of research is not anticipated. The 
subject will continue to see their respective health care providers during scheduled clinic visits. 
 
 
 
13.0 
Data Analysis and Statistical Considerations 
 
Feasibility will be assessed by calculating the acceptance rate, measured as the number of 
patients enrolled divided by the number eligible. In addition, we will evaluate veterans’ reasons 
for enrollment or non-enrollment in the program using patient interviews and semi-structured 
questionnaire (see Appendix 4). No PHI will be recorded in questionnaires obtained from 
eligible but non-recruited veterans.  
 
Acceptability will be measured by rate of compliance with the exercise/nutrition programs. For 
the exercise intervention, the percentage of patients completing ≥75% of sessions divided by the 
number of enrolled patients will be calculated. 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 will be evaluated by the number of adverse events (significant injury or medical event) 
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. 
 
Effect size will be estimated by comparing physical function before and after the prehabilitation 
intervention, as measured by the 5RSTS and the 2-minute step tests using Cohen’s D. Changes 
in health-related quality of life (SF-36) and anxiety and depression (HADS) before surgery and 
at the 6-week and 24-week study periods following surgery will be calculated. 
 
 
14.0 
Privacy, Confidentiality, and Information Security 
 
14.1 
Lists of Data Reviewed and/or Collected for Screening/Recruitment 
and Conduction of Study:  
 
The Personal Health Information that will be obtained, used, and/or shared for this 
study includes: 
Identifier(s) 
Source(s) of Health Information 
 Names 
 Medical history & physical exam 
information 

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Identifier(s) 
Source(s) of Health Information 
 All geographic subdivisions smaller than a 
State, including street address, city, county, 
precinct, and zip code.  Describe: street 
address, city, state, zip code for mailing 
participant payments 
 Photographs, videotapes, audiotapes, or 
digital or other images 
 All elements of dates (except year) for dates 
directly related to an individual, including birth 
date, admission date, discharge date, visit or 
treatment dates, etc.; and all ages over 89, 
Describe: Date of preop evaluation/POSH 
appt.; dates of postop appointments; date of 
surgery; dates of laboratory test results; date 
of birth 
 Biologic specimens (e.g., blood, tissue, 
urine, saliva). Describe: 
 Telephone numbers 
 Progress notes 
 Fax numbers 
 Diagnostic / Laboratory test results 
 Electronic mail addresses 
 Operative reports 
 Social Security Numbers 
 Imaging (x-ray, CT, MRI, etc.) 
 Medical record numbers 
 Discharge summaries 
 Health plan beneficiary numbers 
 Survey / Questionnaire responses 
 Account numbers 
 Billing records 
 Certificate and/or license numbers  
 HIV testing or infection records 
 Vehicle identifiers and serial numbers, 
including license plate numbers  
 Sickle cell anemia information 
 Device identifiers and serial numbers 
 Alcoholism or alcohol use information 
 Web Universal Resource Locators (URLs) 
 Drug abuse information 
 Internet Protocol (IP) address numbers 
 Mental health (not psychotherapy) notes 
 Biometric identifiers, including finger & 
voice prints 
 Psychological test results 
 Full-face photographic images and any 
comparable images 
 Genetic testing 
 Any other unique identifying number, 
characteristic, or code, describe:  Patient 
address including latitude/longitude and 
rural/suburban/urban designation.   
*Note: This is not the unique code assigned to 
otherwise de-identified health information for 
re-identification purposes. 
 Other, describe:        
 
All non-Veterans enrolled in this study will receive the VA Notice of Privacy Practices 
(NOPP) and are requested to sign the acknowledgment form.  The signed 
acknowledgment form will be maintained with the research records. 
14.2 
Data and/or Specimen Acquisition: 
 
Data for this study will be collected through (check all that apply): 
  Prospective data and/or specimen collection obtained from participants. Provide 
description of processes:  Assessments of physical function, mobility, nutrition, 

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anxiety/depression, and health-related quality of life will be collected. Data from the 
medical record will also be accessed and used. 
iPad devices will be issued to relevant participants and become their property.  There will 
be no research data stored on these devices – they are used solely for communicating 
with study team members regarding appointments and food diaries, as well as 
participating in exercise sessions. 
  Retrospective data collection and/or specimens obtained from medical chart 
review/data access.  Describe how data will be obtained (e.g., fileman, CDW, etc.):  
     . 
  Retrospective data collection and/or specimens obtained from an IRB-approved data 
and/or specimen repository.  Indicate the repository source including name, VA location, 
and IRB number:       . 
Note:  for data and/or specimens obtained from a VA approved data repository, a 
Data Use Agreement (DUA) must be executed prior to obtaining data and/or 
specimens.  See VHA Handbook 1200.12 for further information. 
14.3 
Level of Data: 
 
The following level(s) of data will be acquired/maintained for this study (check all that 
apply): 
  Identifiable—Data contains direct identifiers.   
  Coded—Data linked to a specific by a code rather than a direct identifier for re-
identification purposes. Only someone possessing the key to the code can link the data to 
a particular participant.    
  De-Identified (all 18 HIPAA identifiers removed  
  Verified Statistically  
 
OR 
  Verified by Absence or Removal of 18 HIPAA identifiers   
  Limited Data Set 
  Other: Describe:        
14.4 
Location of Data and/or Specimens, and Data Retention Plan 
14.4.1 Data and/or Specimen Location 
 
Hardcopy documents, including surveys, ICFs and HIPAA Forms, will be stored in 
folders and binders and kept inside a locked cabinet in our Anesthesia Research Office 
(C3011A). 
 
Data will be stored electronically on secure VA servers accessible only to study personnel 
through VA workstations—file path S:\Anesthesia Research\Atilio 
Barbeito\PREVENT\Data.  Data that will be stored electronically include screening and 
enrollment logs, adverse events log, and data sets related to functional and nutritional 
assessments. 
 
There will be no research-related data stored on the iPad tablet devices.  

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Paper records of data include ICFs, HIPAA Forms, and assessments on function and 
nutrition and will be stored inside locked cabinets in our research office. 
 
Specimens will not be collected for this research project. 
 
  Data will be also be placed at the VA Informatics and Computing Interface (VINCI; 
http://vaww.vinci.med.va.gov/vincicentral/VINCIWorkspace.aspx). The VA Informatics 
and Computing Infrastructure is a partnership between the VA Office of Information 
Technology and the Veterans’ Health Administration Office of Research and 
Development.  Researchers and operations staff can use VINCI to access data and 
statistical analysis tools in a virtual working environment through a certified VHA 
network computer using the VA Intranet or Virtual Private Network (VPN). 
 
14.4.2 Data Retention Plan 
 
 Research records will be maintained and destroyed according to the National 
Archives and Records Administration, Records Schedule Number:  DAA-0015-2015-
0004.  Records destruction, when authorized, will be accomplished using the then 
current requirements for the secure disposal of paper and electronic records.  Currently, 
destruction of research records (see DAA-0015-2015-0004, section 7.6 “Research 
Investigator Files” for materials included in research records) is scheduled for 6 years 
after the cut-off (the cut-off is the completion of the research project) and may be 
retained longer if required by other federal agencies.  Records will not be destroyed 
without pre-notification to the facility records manager. 
   
  Other data retention plan, describe:        
14.4.3 Data Access and Data Recipients 
Only members of our DVAMC research team will have access to identifiers and coded 
data.  Coded data with direct identifiers removed (i.e., name, address, telephone 
numbers, SSN, DOB) will be placed on secure VA servers accessible only to study 
personnel through VA workstations. Hardcopy documents, kept inside a locked cabinet 
in our Anesthesia Research Office (C3011A), will be accessible to research personnel 
only. 
 
All VA research personnel who have access to VHA records are instructed, in accordance 
with VA policy, on the requirements of Federal privacy and information laws and 
regulations, VA regulations and policies, and VHA policy. All study personnel who are 
VA employees working within the VA system have fulfilled all required HIPAA and other 
VA security and privacy policy training requirements and have agreed to follow 
guidelines pertaining to the protection of patient data. All research staff sign VA Rules of 
Behavior, and all study staff are up to date with VHA Privacy Policy Training and the VA 
Office of Cyber and Information Security Awareness Training Course. The data security 
and privacy procedures summarized in that course include logging off or locking the 
computer when walking away from it; no sharing of access codes, verify codes or 
passwords; not allowing anyone else to use the computer under one’s password; and 
disposing of sensitive information using VA-approved methods (e.g., shredder bins). 
 

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Access to study data will be removed for all study personnel when they are no longer part 
of the research team. 
 
14.5 
Data and/or Specimen Transportation and/or Transmission for all 
data and/or specimens involved in the study 
 
  Data and/or specimens will not be transported or transmitted outside of Durham 
VAMC environment. 
  Data and/or specimens will be transported BETWEEN sites that are under the 
auspices of the Durham VA Medical Center. 
   Data and/or specimens will be transmitted to other VA sites using the following 
method(s): 
 
  Data and/or specimens will be transported to non-VA/VHA sites (e.g., academic 
affiliates, laboratories, etc.) using the following method(s): 
 
 
A. Data 
  Data are de-identified and thus will be sent via unencrypted e-mail or unencrypted 
CD. 
  Data are coded or contain identifiers and thus will be sent via <choose method of 
transfer such as FIPS 140-2 encrypted CD or FIPS 140-2 encrypted hard drive/flash 
drive> using VA—approved carrier with tracking.   
  Data are coded or identified and will be sent via the Safe Access File Exchange 
(SAFE) at https://safe.amrdec.army.mil/safe/.  SAFE is a secure method of exchanging 
files <2GB to and from individuals with a valid .gov, .mil, .com, or .edu email address. 
<insert information including collaborator name.> 
  Data are coded or identified and will be uploaded to sponsor website using electronic 
case report form (eCRF) <insert information including sponsor name and URL and the 
encryption the site uses.> 
 Other, describe:       
B. Specimens 
  Specimens are de-identified and thus will be sent via standard carrier (tracking is 
optional) or will be hand-delivered by research study personnel.  Specify method of 
delivery:        
  Specimens are coded and thus will be sent via VA-approved carrier with tracking or 
will be hand-delivered by research study personnel.  Specify method of delivery:        

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In accordance with the HIPAA and the Privacy Act, for any coded or identifiable data or 
specimens released from the Durham VAMC (with the exception of Limited Data Sets), 
an Accounting of Disclosure (AOD) will be maintained (e.g., in a database or 
spreadsheet) that includes the participant’s name, date of the disclosure, description of 
the nature of the Individually Identifiable Information (III) disclosed, purpose of each 
disclosure, and the name and address of the person/agency to whom the disclosure was 
made. 
C.   
 Local DVAMC memorandum “Authorization to Use, Process, Store, or Transmit 
VA Sensitive Information Outside VA Owned or Managed Facilities” has been pre-filled 
out for each study team member who may transport the data and/or specimens off-site.  
This (these) forms are included with the IRB materials. 
D.   
  Containers (e.g., briefcase, bin) are labeled with the following notice (label 
placed on the outside of container) in accordance with VHA Directive 6609: 
NOTICE!!! 
Access to these records is limited to: AUTHORIZED PERSONS ONLY. 
Information may not be disclosed from this file unless permitted by all applicable legal 
authorities, which may include the Privacy Act; 38 U.S.C. §§ 5701, 5705, 7332; the Health 
Insurance Portability and Accountability Act; and regulations implementing those 
provisions, at 38 C.F.R. §§ 1.460 – 1.599 and 45 C.F.R. Parts 160 and 164. Anyone who 
discloses information in violation of the above provisions may subject to civil and criminal 
penalties. 
 
  We will communicate with veterans enrolled as participants in this research study 
through MyHealtheVet.    
14.7 
Risk Mitigation Strategies 
 
All VA research personnel who have access to VHA records are instructed, in accordance 
with VA policy, on the requirements of Federal privacy and information laws and 
regulations, VA regulations and policies, and VHA policy. All study personnel who are 
VA employees working within the VA system have fulfilled all required HIPAA and other 
VA security and privacy policy training requirements and have agreed to follow 
guidelines pertaining to the protection of patient data. All research staff sign VA Rules of 
Behavior, and all study staff are up to date with VHA Privacy Policy Training and the VA 
Office of Cyber and Information Security Awareness Training Course. The data security 
and privacy procedures summarized in that course include logging off or locking the 
computer when walking away from it; no sharing of access codes, verify codes or 
passwords; not allowing anyone else to use the computer under one’s password; and 
disposing of sensitive information using VA-approved methods (e.g., shredder bins). 
Access to study data will be removed for all study personnel when they are no longer part 
of the research team. 
 
  Data are fully de-identified (stripped of HIPAA 18 and study ID/code) before being shared 
outside of Durham VAMC. 

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  Specimens are fully de-identified (stripped of HIPAA 18 and study ID/code before being 
shared outside of Durham VAMC. 
  Data or specimens are coded, and the code is not related to, or derived from, information 
about the individual and that code is not otherwise capable of being translated as to the identify 
the individual. Only someone possessing the key to code can link the data to a particular 
participant. 
   
  Other, specify:        
14.8 
Suspected Loss of VA Information 
 
Should any incident such as theft or loss of data, unauthorized access of sensitive data or 
non-compliance with security controls occur it will be immediately reported according to 
VA policy. All incidents regarding information security/privacy incidents will be reported 
to the ISO and PO within 1 hour of acknowledgement of issue and done so using the 
VHADUR Research Events Report e-mail group 
(VHADURResearchEventReport@va.gov). 
 
14.9 
Reporting of Results 
 
  Reporting of results, such as in scientific papers and presentations, will never identify 
individual subjects.  Data will be presented in aggregate and individual-level data will not be 
published. 
  Other results reporting plan, describe:       
 
14.10 Future Use of Data 
 
  Data will be retained for future use.  This is described elsewhere in the protocol and is noted 
in the HIPAA authorization. 
 
  Future Use of data is optional (i.e., not required by the research subject). 
  Future Use of data is required for participation in the study. 
  No future use of data is currently planned. 
14.11 Use of Mail Merge Technology 
 
  Mail merge programs will be used to generate letters and/or address labels for mailings to 
potential or already enrolled research subjects.  The study team is aware that to reduce risk of 
mail merge related privacy incidents, use of mail merge programs requires a 25% accuracy check 
to verify that (potential) research subject name and mailing address are properly “matched”.  If 
discrepancies are found, a 100% accuracy check is required before letters may be mailed.   
14.12 Use of Non-Standard Software 
 

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 I do NOT intend to use any new specialized software (i.e. Software that’s not already 
approved OR installed) in this study. 
 
 I intend to use specialized software that has not already been installed and it has been 
approved for use by the VA Technical Reference Model (TRM) Group.  
(Note: All new software must be approved by TRM before it can be installed on VA systems.) 
 I intend to use previously installed software on my VA computer.  
 
14.13 Use of Cloud Computing Services 
 
 Cloud computing services will NOT be used in this study. 
 
 Cloud computing services WILL be used in this study as described below and have been 
approved nationally by the VA Chief Information Officer (CIO).  (Note: ONLY cloud computing 
services that have been approved nationally may be used.) 
 
 
 

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15.0 
References 
 
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Major Abdominal Surgery in Elderly Patients: Intersection of Age, Functional Status, and 
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3. Older P, Hall A, Hader R. Cardiopulmonary exercise testing as a screening test for 
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4. Moran J, Wilson F, Guinan E, McCormick P, Hussey J, Moriarty J. Role of cardiopulmonary 
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6. Lai CW, Minto G, Challand CP, et al. Patients' inability to perform a preoperative 
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7. Kaibori M, Ishizaki M, Matsui K, et al. Assessment of preoperative exercise capacity in 
hepatocellular carcinoma patients with chronic liver injury undergoing hepatectomy. BMC 
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8. Robinson TN, Wallace JI, Wu DS, et al. Accumulated frailty characteristics predict 
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11. Wilkinson SB, Phillips SM, Atherton PJ, et al. Differential effects of resistance and endurance 
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13. Kim DJ, Mayo NE, Carli F, Montgomery DL, Zavorsky GS. Responsive measures to 
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26. Morey MC, Lee CC, Castle S, et al. Should Structured Exercise Be Promoted As a Model of 
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27. Morey MC, Pieper CF, Crowley GM, Sullivan RJ, Puglisi CM. Exercise adherence and 10-year 
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28. McDonald SR, Porter Starr KN, Mauceri L, et al. Meal-based enhancement of protein quality 
and quantity during weight loss in obese older adults with mobility limitations: Rationale and 
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prevention of major mobility disability in older adults: the LIFE study randomized clinical trial. 
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35. Rikli RE, Jones CJ. Development and validation of criterion-referenced clinically relevant 
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41. Tariq SH, Tumosa N, Chibnall JT, Perry Iii MH, Morley JE. Comparison of the Saint Louis 
University Mental Status Examination and the Mini-Mental State Examination for Detecting 

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Dementia and Mild Neurocognitive Disorder—A Pilot Study. The American Journal of Geriatric 
Psychiatry. 2006;14(11):900-910. 
 
42. Bohannon RW. Test-retest reliability of the five-repetition sit-to-stand test: a systematic 
review of the literature involving adults. J Strength Cond Res. 2011;25(11):3205-3207. 
 
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Assessment (PG-SGA) as a nutrition assessment tool in patients with cancer. Eur J Clin Nutr. 
2002;56(8):779-785. 
 
44. Mueller C, Compher C, Ellen DM. A.S.P.E.N. clinical guidelines: Nutrition screening, 
assessment, and intervention in adults. JPEN Journal of parenteral and enteral nutrition. 
2011;35(1):16-24. 
 
45. Jenkinson C, Coulter A, Wright L. Short form 36 (SF36) health survey questionnaire: 
normative data for adults of working age. BMJ. 1993;306(6890):1437-1440. 
 
46. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 
1983;67(6):361-370. 
 
 
  
 

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Appendix 1. Expedited Review of Research 
 
The categories of research that may be reviewed by the IRB through the expedited review 
procedure include research activities that present no more than minimal risk to human subjects 
AND involve procedures listed in one or more of the specific categories listed below. 
 
The expedited review procedure is not to be used when identification of the subjects or their 
responses would reasonably place them at risk of criminal or civil liability; be damaging to the 
subjects’ financial standing, employability, insurability, or reputation; or be stigmatizing, unless 
reasonable and appropriate protections are implemented so that risks related to invasion of 
privacy and breach of confidentiality are no greater than minimal.   The IRB must apply the 
standard requirements for informed consent (or its waiver, alteration, or exception) to all 
studies that undergo expedited review. 
 
EXPEDITE CATEGORIES  
1-Drugs and Devices:  One of the following must be met: 
 (1) The research is on drugs for which an IND application is not required.   
 (2) The research is on medical devices for which an investigational device exemption (IDE) 
application is not required; or the medical device is cleared or approved for marketing, and the 
medical device is being used in accordance with its cleared or approved labeling. 
 
2-Blood Samples:  Collected by finger / heel / ear stick or venipuncture: 
 (1) From healthy, nonpregnant adults who weigh at least 110 pounds.  For these subjects, the 
amounts drawn may not exceed 550 milliliters (ml) in an 8-week period, and collection may 
not occur more frequently than two times per week; or 
 (2) From other adults and children, considering the age, weight, and health of the subjects, the 
collection procedure, the amount of blood to be collected, and the frequency with which it will 
be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml 
per kilogram (kg) in an 8-week period, and collection may not occur more frequently than two 
times per week.   
 
3-Noninvasive Collection of Biological Specimens:  Collected prospectively for research 
purposes by noninvasive means: 
(1) Hair and nail clippings in a non-disfiguring manner.  
(2) Deciduous teeth at time of exfoliation or if routine patient care indicates a need for 
extraction.  
(3) Permanent teeth if routine patient care indicates a need for extraction. 
(4) Excreta and external secretions (including sweat). 
(5) Uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing 
gumbase or wax or by applying a dilute citric solution to the tongue. 
(6) Placenta removed at delivery. 
(7) Amniotic fluid obtained at the time of rupture of the membrane prior to, or during, labor. 
(8) Supra- and subgingival dental plaque and calculus, provided the collection procedure is not 
more invasive than routine prophylactic scaling of the teeth and the process is accomplished in 
accordance with accepted prophylactic techniques.  
(9) Mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings. 
(10) Sputum collected after saline mist nebulization. 
4-Noninvasive Collection of Data:  Data must be collected through noninvasive 
procedures (not involving general anesthesia or sedation) routinely employed in clinical 
practice, excluding procedures involving x-rays or microwaves.   

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EXPEDITE CATEGORIES  
(1) Physical sensors that are applied either to the surface of the body or at a distance and do not 
involve input of significant amounts of energy into the subject or an invasion of the subject's 
privacy.  
(2) Weighing the subject. 
(3) Testing sensory acuity.  
(4) Magnetic resonance imaging (MRI).  
(5) Electrocardiography, electroencephalography, thermography, detection of naturally 
occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, Doppler 
blood flow, and echocardiography. 
(6) Moderate exercise, muscular strength testing, body composition assessment, and flexibility 
testing, where appropriate, given the age, weight, and health of the individual. 
 
5-Collected Material: Research involves: 
(1) Materials (data, documents, records, or specimens) that have been collected for any 
purpose, including previous research; or 
(2) Materials (data, documents, records, or specimens) that will be collected solely for 
nonresearch purposes (such as medical treatment or diagnosis).  
 
6-Collection of Data From Voice, Video, or Photographs:  Research involves collection 
of data from voice, video, or photographs. 
 
7-Group Characteristics, Surveys, Interviews, and Quality Assurance:  Research 
must be on individual or group characteristics or behavior (including, but not limited to:  
research on perception, cognition, motivation, identity, language, communication, cultural 
beliefs or practices, and social behavior), or will employ survey, interview, oral history, focus 
group, program evaluation, human factors evaluation, or quality assurance methodologies.  
NOTE:  Some research in this category may be exempt from the VA regulations for the 
protection of human subjects (38 CFR 16.101(b)(2) and (b)(3)).  This listing refers only to 
research that is not exempt. 
 
 
 

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Appendix 2. Progressive Functional Exercise Routine for Home-Based 
Prehabilitation 
General Principles 
Home-based exercise requires adaptations for the lack of equipment typically available 
in facility-based programs and for widely varying functional states of program 
participants.  Building on known evidence-based progressive programs such as the 
Otago program and substantial work developed by our Gerofit team, we deploy a 
continuous cardio and strength circuit training program using increased cadence, body 
weight, and resistive bands to increase intensity of effort. The program follows 
recommended guidelines for older adults, with four levels of intensity based on the 
baseline functional status of participants, as described in the tables below.   
The exercise intervention of this multimodal prehabilitation program will consist of 
moderate intensity cardio and strength training exercises performed in succession to 
warrant continuous cardiovascular benefit. The number of rounds of aerobic and 
functional exercises will be progressed as fitness improves, with an entire sequence 
being completed in 30 minutes (Table 1). The RPE will be assessed after each round to 
help patients keep intensity within moderate levels. Exercise sessions will also include 5-
minute warm up and cool down sections at light intensity (RPE 2-3) to ensure safety 
and recovery of all participants.  
As patients progress, up to 4-6 rounds of aerobic circuits (Table 2) and 2-3 rounds of 
functional resistance exercises (Table 3) may be completed.  Given the limited timeline 
of prehabilitation, participants will be encouraged to increase at least one or more levels 
where possible at each session. In addition to the supervised exercise sessions, Veterans 
be asked to monitor and increase daily step counts, allowing for one day of rest each 
week. 
 
Table 1. General Structure of the Exercise Program 
 
Duration 
Intensity 
Warm-up 
5 min 
2-3 RPE 
Aerobic and Resistance 
Exercise Circuit  
30 min2 
Aerobic: 4-6 RPE 
Resistance: 6-7 RPE 
Cool down 
 
 
5 min 
 
2 The duration of the circuit will be progressed towards the 30 minute goal 

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Table 2. Aerobic Exercise Circuit 
One circuit of aerobic exercises features 30 seconds per exercise, for a total of aprox. 5 
minutes. All exercises are adapted for different levels of ability. Exertion will be assessed 
after each circuit level and adjusted to keep intensity within the moderate range (RPE 4-
6). 
 
Aerobic 
Exercise 
Circuit 
Level 1 
Most 
Deconditioned 
Level 2 
Level 3 
Level 4 
Least 
Deconditioned 
Marching 
Seated 
1 arm support 
Unsupported 
Higher step march 
Forward/ 
Backward 
March 
Seated 
1 arm support 
Unsupported 
Unsupported 
increased speed 
March w/ arm 
swing 
Seated 
1 arm support 
Unsupported 
Higher 
swings/speed  
to sustain RPE 
Step both feet 
out, step in 
Seated 
1 arm support 
Unsupported 
Wider step 
Single leg toe 
taps (R)  
Seated 
Standing two 
arm support 
Standing two 
arm support 
Standing two arm 
support  
 
 
 
 
 
Single leg toe 
taps (L) 
Seated 
w/ toe tap to 
shoulder width 
w/ toe tap 
wider than 
shoulder 
w/ wide step with  
increased speed 
Step Jacks 
Seated 
Standing w/ 1 
hand support 
Standing no 
support 
Standing increased 
speed to sustain 
RPE 
Mini-Squat 
and cross 
punch 
Seated 
Standing w/ 1 
hand support 
Standing no 
support 
Standing increased 
speed  
to sustain RPE 
Walking with 
hand claps 
Seated 
Standing arm 
claps only 
Standing arm 
claps + 
stepping 
Standing arm claps 
+ stepping increased 
speed 
Heel Taps 
Seated 
Standing 1 arm 
support 
Standing 
unsupported 
Standing increased 
speed to sustain 
RPE 
 
 
 

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Table 3. Functional Resistance Training Exercises 
One set of functional resistance training exercises will be performed following two 
rounds of aerobic circuits. Between 8 and 12 repetitions of the training exercises will be 
performed as indicated and tolerated by the patient. Exertion will be measured 
following one set of the strength exercises to best determine resistance and intensity 
levels, with the goal RPE being 6-7.  
Functional 
Exercise 
Circuit 
Level 1 
Most 
Deconditioned 
Level 2 
Level 3 
Level 4 
Least 
Deconditioned 
 
 
 
 
Chair stands 
Use Arms 
Arms in front 
Arms across 
chest 
Arms across 
chest  
Mid back row 
Yellow 
Red 
Green 
Blue 
Hip Abduction 
Seated w/ 
band 
Standing 
straight leg 
Lateral band 
walk 
Lateral band 
walk 
arm 
supported, no 
band 
Yellow/Red 
Green/Blue 
 
 
 
 
 
Hip Extension 
Standing 
straight leg 
Standing 
straight leg 
Standing bent 
knee ext. 
Standing bent 
knee ext. 
Bicep Curls 
Seated, yellow 
Standing 
yellow/red 
Standing 
red/green 
Standing 
green/blue 
Abdominal hold 
Seated, bent 
knee off floor 
Seated straight 
leg off floor 
Seated straight 
leg off floor,  
arms overhead 
Seated straight 
leg off floor, 
Arms overhead 
Chest Press 
Yellow 
Red 
Green 
Blue 
Tricep Dips 
Dip w/knees 
bent feet flat 
Dip w/ knees 
bent feet flat 
Dip with legs 
extended 
Dip with legs 
extended 
 
 
 
 

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Appendix 3. Patient Eligibility and Monitoring Based on Kidney Function 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Yes 
No 
GFR <30 
ml/min/1.73 
m
2 
  
  
Measure serum creatinine level and estimate glomerular filtration (GFR) 
Confirmator
y test for 
GFR <30 or 
>10% drop 
  
  
  
 Exclude from the study 
Repeat GFR in 
4 weeks 
Repeat GFR in  
4 weeks 
 
Eligible for the study 
 
Eligible for the study 
with monitoring 
Measure serum creatinine level and  
estimate glomerular filtration  
(GFR) at 6 weeks postoperative time point 
  
No 
No 
Yes 
Yes 
GFR <30 
ml/min/1.73
GFR 30-59 
ml/min/1.73
GFR ≥60 
ml/min/1.73
GFR <30 
ml/min/1.73 m
2 
or >10% drop 
GFR <30 
ml/min/1.73 
m
2 
Repeat GFR in 
4 weeks 

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Appendix 4. PREVENT Acceptance/ Non-acceptance Questionnaire 
1. Are you willing to enroll in this exercise and nutrition program? 
a. Yes 
b. No 
 
If YES, then please answer questions 2 and 3. If NO, then answer question 4.  
2. If YES, what are you seeking to accomplish with this program? 
a. I want to improve my overall fitness and/or nutrition in general, and this is a 
great opportunity to do it 
b. I want to do well in surgery 
c. Other 
 
3. If YES, which ONE element is MOST attractive to you about this program? 
a. The physical exercise routine 
b. The nutritional support component 
c. The phycological support and close monitoring I will receive 
d. Other 
 
4. In NO, what is the MAIN reason for not enrolling in this program? 
a. I don’t think I have the physical energy to participate in this program 
b. I don’t like or want to take any nutritional supplements 
c. I don’t want to receive text messages  
d. I don’t want to wear an activity tracker 
e. I am not in the mood to participate in this program 
f. I don’t have internet access at home 
g. I am not comfortable with technology 
h. Other 
 
 
Appendix 5:  For dropouts: 
1. Why did you stop participating in this program? 
a. I don’t see the utility of this 
b. The exercise routine is too hard 
c. The exercise routine is boring 
d. I don’t like the trainer 
e. I don’t like the nutritional supplements  
f. I don’t like the text messages and/or phone calls 
g. I can’t figure out how to use the device 
h. I don’t have the time 
i. Other 
 
2. How many sessions did you participate in? 
 
 
 

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Appendix 6:  USDA 5-Step Multiple Pass Method**