Evaluating the Impact of Targeted Physical Activity on Clinically Debilitated Dialysis Patients.
Phase: NA
Conditions: Frailty, Pain, Chronic, Dialysis; Complications, Kidney Diseases
Sponsor: University of Illinois at Chicago

 
 
Exercise and dialysis, version: 24 
Date: 07/25/2023 
Page 1 of 46 
 
 
 Randomized Case-Control Trial evaluating the impact of targeted physical 
activity on clinically debilitated dialysis patients.  
Principal Investigator: 
Enrico Benedetti, MD 
Professor and Head 
Department of Surgery 
University of Illinois Hospital and Health Sciences System 
 
 
 
Study Location(s): UIC Disability Health and Social Policy Building (DHSP) located at 
1640 W. Roosevelt Road & and the UIC Outpatient Clinic, located at 1855 W Taylor, 
Specialty Care Building (SCB), located at 1009 S Wood St, Chicago, IL 60612, and 
GhFitlab 1527 Waukegan Rd, Glenview, IL 60025. 
 
 
 
 
 
 
Version: 24 
Date: 07/25/2023 
 
 
  
 
 
 
 
 
 
 

 ____________________________________________________________________________________________ 
Exercise and dialysis, version: 24 
Date: 07/25/2023 
Page 2 of 60 
 
1.0 
Project Summary/Abstract 
This randomized case control trial will investigate the effects of an exercise intervention 
on clinically debilitated dialysis/kidney disease patients. The 12-Month Randomized 
Trial Group will include a total of 150 patients from UI Health (≥ 18 years of age), who 
are on dialysis, or have chronic kidney disease stage 4 (CKD 4 = GFR between 15 and 
29), or have chronic kidney disease stage 5 (CKD 5 = GFR below 15) and are 
considered clinically debilitated by their direct healthcare professional will be enrolled. 
Randomization will be a 2:1 ratio (100 intervention, 50 control).  The intervention arm 
will perform a 12-month exercise intervention which involves two days a week of 
personalized exercise rehabilitation.  The control arm will receive no exercise 
intervention.  Both arms of patients will be tested on various measures of health and 
function both at baseline (prior to intervention) at 6 months, and at 12 months (post 
intervention). This study will also investigate the effects of an exercise intervention on a 
subgroup of pre- and post- kidney transplant patients (PPKT Subgroup). This subgroup 
will include a total of 100 patients (≥ 18 years of age), who are on dialysis, or have CKD 
stage 4 or 5, and are considered clinically debilitated by their direct healthcare 
professional will be enrolled, or post- renal (kidney) transplant.  This subgroup will 
perform 36 visits of exercise intervention which involves two days a week of 
personalized exercise rehabilitation.  We will also utilize validated surveys and 
assessment tools to assess health issue management and depression severity. A study 
total of 250 patients are included in this protocol (Table A.). All testing and result 
interpretation will be performed by trained research personnel that are IRB approved. 
Table A. 
 
 
2.0     Background/Scientific Rationale  
While it is well known exercise is beneficial for the general population, it is especially 
important for patients undergoing dialysis to help control many side effects of the 
treatment (1). Despite this being true, the physical activity levels in this population tend 
to be low (2). There are several reasons for the low physical activity levels in this 
12-Month 
Radonmized Trial 
Group (150 dialysis 
patients)
Excercise Intervention 
Arm
Control Arm
PPKT Subgroup (100 
pre- and post- kidney 
transplant patients)
Exercise Intervention 
Arm Only

 ____________________________________________________________________________________________ 
Exercise and dialysis, version: 24 
Date: 07/25/2023 
Page 3 of 60 
 
population, including both physical inability die to increased fatigue as well as negative 
perceptions of exercise and potential barriers (3).  Patients undergoing dialysis have a 
high prevalence of muscle atrophy, lower functional capacity, as well as a high risk of 
cardiovascular complications (1).  As chronic kidney disease progresses, skeletal 
muscle dysfunction progresses as well, leading to potential mobility limitations, loss of 
independence, and the vulnerability for disease complications (4).  Reduced physical 
capacity, which partners with a reduced cardiovascular capacity, has been identified as 
an independent risk factor of mortality in this population (5). Furthermore, when a 
patient presents with high levels of frailty before kidney transplantation, about 1 in 6 
patients, research has shown lower rates of preemptive transplantation, older recipient 
age, higher rates of delayed graft function, and longer length of stay hospital stays (6).   
In addition, after renal transplantation, obesity and metabolic syndrome are prominent 
risk factors for post-transplantation diabetes mellitus, chronic graft dysfunction, graft 
loss, and patient death in kidney transplant recipients (7).  
 
Exercise has been shown to be beneficial in dialysis and kidney transplant patients by 
improving functional capacity, quality of life, and strength levels. (2,4,8).  It is important 
to remember when prescribing exercise to dialysis patients, that they may have several 
limitations and have already experienced deficits as a result of the disease (8). Because 
of this it is important to have a personalized exercise program for this population that is 
safe and effective to reduce the side effects of chronic kidney disease and dialysis 
treatment.  
 
 
 
 
3.0 
Objectives/Aims 
The present study aims to analyze the effectiveness of a specific physical activity 
training program (aka GH Method) in clinically debilitated dialysis/kidney 
disease//post kidney transplant patients.   
 
Hypotheses: 
12-Month Randomized Trial Group- 
Exercise will positively affect body composition. With this hypothesis we will test 
whether muscle strength (dynamometer) and muscle mass (DEXA scan) changes after 
12 months of an exercise intervention. Baseline measurement will be performed before 
the intervention and at the end of the study (12 months) with muscle mass measured by 
DEXA  
 

 ____________________________________________________________________________________________ 
Exercise and dialysis, version: 24 
Date: 07/25/2023 
Page 4 of 60 
 
1. We expect patients will see improvements in their physical abilities after 12 
months in the exercise training sessions. This will be assessed by comparing 
baseline and 12 month 8 foot walk, timed sit to stand, and balance testing scores. 
2. Patients enrolled in the exercise intervention will have an overall improved sense 
of well-being, increased independence, quality of life, and decreased depression.  
Patients will be asked about their overall general health, mental health and pain 
intensity using the PROMIS, SF 36, BDI, and ADL questionnaires. 
3. Through the optional arm muscle biopsy, we expect to see how targeted exercise 
may change muscle development measuring expression of mature microRNAs 
using total RNA extraction. 
PPKT Subgroup- 
1. We expect pre- and post- kidney transplant patients will see improvements in their 
physical abilities and strength. This will be assessed monthly using the Pre-
Transplant Frailty Assessment (Frailty Score). 
2. We also expect patients to have a better management of their healthcare issues 
and a better understanding of current behavioral health, specifically their 
depression levels using the validated Patient Activation Measure (PAM) Survey 
and Patient Health Questionnaire-9 (PHQ-9). 
 
4.0 
Eligibility 
The 12-Month Randomized Trial Group will enroll patients who are 18 years of 
age or older, are on dialysis, or have CKD stage 4 or 5 and are considered 
clinically debilitated by their healthcare professional.  
 
Patients will be recruited from their pre-transplant clinic directly, using patient 
completion story video and screened by either the primary investigator, a co-
investigator, or another member of the research staff and/or via recruitment flyer 
and phone screening script. Subjects can also be recruited by referral by Dr. 
Lorenzo Gallon at the Northwestern Medicine. He will provide potential 
participants with an information sheet that will provide a brief summary of the 
research study and who to contact, if interested. They will then be screened and 
consented by authorized research staff, if eligible to participate. Subjects will 
bring a copy of their medical records.  
 
The PPKT Subgroup will include new patients that are not enrolled in the 12-
Month Randomized Trial Group, who are pre- and post- kidney transplant (≥ 18 
years of age), on dialysis, or have CKD stage 4 or 5, or post kidney transplant. 
Patients will be recruited from their pre- or post- transplant clinic, or when the 
patient is referred for evaluation.  The patient will be screened by either the 
primary investigator, a co-investigator, or another member of the research staff. 
Interested patients will be consented to participate by authorized staff.  
 

 ____________________________________________________________________________________________ 
Exercise and dialysis, version: 24 
Date: 07/25/2023 
Page 5 of 60 
 
 
Inclusion Criteria 
 
• Clinically debilitated patients, currently on dialysis, or have CKD 4 (GFR 
between 15 and 29), or have CKD 5 (GFR below 15), or post- kidney 
transplant (for PPKT Subgroup only) as stated by patient’s health care 
professional. 
• Adequate cognitive ability to complete the questionnaires, give consent for 
the study and follow the physical and diet instructions 
• 18 years of age and older 
 
6.0 Exclusion Criteria 
• cardiac/pulmonary disease that contraindicate the physical training 
• any contraindication to exercise testing per the American Heart Association 
• unable to comply with the training program 
 
6.0 Excluded or Vulnerable Populations 
• No vulnerable population will be enrolled in this study. This includes 
pregnant women, minors, decisionally impaired, and prisoners. 
• The 12-Month Randomized Trial Group and PPKT Subgroup will include 
Spanish speakers and will exclude other non-English speaking subjects as 
they would not be able to complete intensive survey requirement of the 
study as all surveys will be administered in the English or Spanish language.  
 
 
5.0 
Subject Enrollment  
• Subjects will be screened by investigator or co-investigator using electronic 
medical record and enrolled if subject meets inclusion criteria.  
• Subjects may be recruited at the University of Illinois at Chicago pre or post 
transplant clinic (for PPKT Subgroup only). 
• For the 12-Month Randomized Trial, subjects may also be recruited using 
patient completion story videos seen on social media, gh website, or UIC 
donation website. 
• For the 12-Month Randomized Trial, subjects may also be recruited via 
recruitment flyer and telephone screening phone script. 
• For the 12-Month Randomized Trial, subjects can also be recruited by 
referral by Dr. Lorenzo Gallon at the Northwestern Medicine. He will 
provide potential participants with an information sheet that will provide a 
brief summary of the research study and who to contact, if interested.  
• Only new patients, who are not enrolled in the 12-Month Randomized 
Trial, will be included in the PPKT Subgroup.  
• All screening failures will be recorded in a password protected excel 
spreadsheet. 

 ____________________________________________________________________________________________ 
Exercise and dialysis, version: 24 
Date: 07/25/2023 
Page 6 of 60 
 
• Eligible patients will give voluntary informed consent to participate in the 
study. 
 
6.0 
Study Design and Procedures 
 
The 12-Month Randomized Trial Group 
This group will include 150 patients on dialysis, or have CKD 4 or 5, randomized to 
either the exercise intervention arm, which involves patients  participating in a 12 
month exercise rehabilitation intervention, or to the control arm, which is no 
intervention. Randomization will be a 2:1 ratio (100 intervention, 50 control). The 
intervention arm will consist of a total of 99 visits (3 study testing visits and 96 
exercise visits).  The intervention arm will receive a targeted exercise intervention for 
12 months. Patients will come in for data collection visits at baseline (prior to starting 
the exercise program), 6 months, and 12 months. Each of those visits will take about 
2-3 hours. All testing done in the 3 test visits will help assess the patient’s 
cardiovascular and functional responses and/or changes to the exercise intervention 
as indicated in the Objectives/Aims Section. The next section contains a list of the 
tests that will be performed at each visit.  After the initial baseline visit, patients will 
come twice weekly, for roughly 1 hour each session, for 12 months (96 visits total). 
The control arm will only complete the 3 data collection visits.  All visits will occur at 
the UIC Disability Health and Social Policy Building (DHSP) located at 1640 W. 
Roosevelt Road in Suites 158, 190, and 195. Additionally, patients in the control arm 
of this study will be offered compensation for participating in this study and parking 
vouchers for study visits.  
PPKT Subgroup 
This group will include 100 pre- and post- kidney transplant patients. Participation is 
36 visits of exercise rehabilitation intervention twice a week, for roughly 1 hour.  At 
their initial (baseline), 8th, 12th, 16th, 24th, 32nd, and 36th visit additional time of roughly 
30 minutes-1 hour will be added for patients to also complete survey/assessments. 
We will also need to review medical history, lab/surgical/pathology reports in the 
EMR.  All visits will occur at the Specialty Care Building, Transplant Rehab Gym, 
Suite 1006, 1009 S. Wood St., Chicago, IL 60612, or UIC Disability Health and Social 
Policy Building (DHSP) located at 1640 W. Roosevelt Road in Suites 158, 190, and 
195, GhFitlab, located at 1527 Waukegan Rd, Glenview, IL 60025. 
 
The 12-Month Randomized Trial Group:  
Both Intervention and Control Study Testing Visits: 
Mental Health and Quality of Life Assessments 
The following questionnaires will be performed at baseline, at 6 & 12 months: 
• The PROMIS v.1.2 - Global Health short form will be administered to all 
patients. The PROMIS v.1.2 - Global Health short form will assess health in 

 ____________________________________________________________________________________________ 
Exercise and dialysis, version: 24 
Date: 07/25/2023 
Page 7 of 60 
 
general (i.e. overall health). The PROMIS Global Health short form is a 10-
item instrument representing multiple domains (physical function, fatigue, pain, 
emotional distress, social health) as well as perceptions of general health that 
cut across domains. Global items allow respondents to weigh together 
different aspects of health to arrive at a “bottom-line” indicator of their health. 
Similar global health items have been found predictive of future health care 
utilization and mortality. 
• PROMIS 29 Profile v2.0 will be administered to all patients at the time of 
enrollment, at 6 months, and at 12 months. The PROMIS 29 Prolife v2.0 is a 
short form containing four items from seven PROMIS domains (Depression, 
Anxiety, Physical Function, Pain Interference, Fatigue, Sleep Disturbance, and 
Ability to Participate in Social Roles and Activities) along with a single item on 
Pain Intensity. 
• SF 36 will be administered to all patients at the time of enrollment, at 6 
months, and at 12 months. The SF-36 has eight scaled scores; the scores are 
weighted sums of the questions in each section. Scores range from 0 - 100 
Lower scores = more disability, higher scores = less disability Sections: • 
Vitality • Physical functioning • Bodily pain • General health perceptions • 
Physical role functioning • Emotional role functioning • Social role functioning • 
Mental health  
• The Beck’s Depression Inventory (BDI) will be administered to all patients at 
the time of enrollment, at 6 months, and at 12 months. BDI is a validated to 
measure depression in a general medical population and in chronic disease 
patients. 
• The Katz Index of Independence in Activities of Daily Living (ADL) will be 
administered to all patients at the time of enrollment, at 6 months, and at 12 
months. The Katz ADL is the most appropriate instrument to assess functional 
status as a measurement of the patient’s ability to perform activities of daily 
living independently. Clinicians typically use the tool to detect problems in 
performing activities of daily living and to plan care accordingly. The Index 
ranks adequacy of performance in the six functions of bathing, dressing, 
toileting, transferring, continence, and feeding. Clients are scored yes/no for 
independence in each of the six functions. A score of 6 indicates full function, 
4 indicates moderate impairment, and 2 or less indicates severe functional 
impairment. 
• The patients will be asked to rate their average pain level from dialysis related 
cramping scores on a scale of 0-10 (0 no pain, 10 max pain). They will also be 
asked how often they have these cramps, the location of them, and regular 
duration. 
• Patients will be asked to disclose the number of hospital visits they have had 
in the last 6 months. This will be collected at baseline, 6 months and 12 
months. 

 ____________________________________________________________________________________________ 
Exercise and dialysis, version: 24 
Date: 07/25/2023 
Page 8 of 60 
 
Body composition, strength and functional capacity 
All of the following assessments will be performed at baseline, 6 months, and 12 
months 
• BMI will be calculated.  The patients will be DEXA scanned to provide the data 
about lean/fat tissue in specific body regions. Waist circumference as well as 
blood pressure will be measured for general health markers  All of the 
following assessments will be performed at baseline, 63 months, and 12 6 
months 
• Waist Circumference: Waist circumference will be measured for general health 
markers.  Measurements will be taken at the narrowest part of the torso 
(above the umbilicus and below xiphoid process) in the standing position using 
a tape measure. 
• Blood Pressure: Blood pressure will be measured in the seated position in a 
dimly lit room after resting for five minutes. Resting blood pressure will be 
measured in the brachial artery using a digital sphygmomanometer according 
to the guidelines of the American Heart Association. Blood pressure will be 
measured twice, one minute apart, and the average of the two values will use 
as resting blood pressure. 
• DEXA Scan: We will determine percent body fat via a whole body scan by dual 
energy x-ray absorptiometry (GE, IDXA, Madison, Wi), which will be operated 
and calibrated using the manufacturer’s stated guidelines.  The duration of the 
scan will be less than 10 min and the subject will be exposed to a radiation 
dose of 0.3 mrem based upon the manufacturer’s specifications and 
calculations from Standford Dosiometry, LLC RADAR Medical Procedure 
Radiation Dose Calculator.  This amount of research protocol radiation 
exposure is minimal given the estimated effective equivalent dose is below the 
100 mrem per year, a limit set by the Nuclear Regulatory Commission for 
“general public” exposure. 
• Grip strength in kilogram (kg), average of three trials. This will be measured in 
each subjects’ dominant hand using a hand dynamometer. Contractions will be 
performed in the seated position with the dominant arm at a 90 degree angle. 
• Gait speed in meters/second. Subjects will be asked to walk eight feet as 
quickly as they could. Patients unable to walk at all (i.e., wheelchair bound) 
were assigned a gait speed of 0.01 meters/second. 
• Timed repeated chair stands. Starting from a seated position, subjects will be 
asked to stand up and sit down without using their arms for assistance for a 
total of five times without assistance. Patients unable to perform this test at all 
were assigned a chair stands score of 32 seconds, the 99%ile value among 

 ____________________________________________________________________________________________ 
Exercise and dialysis, version: 24 
Date: 07/25/2023 
Page 9 of 60 
 
patients who were able to perform this test. Patients will also be asked to 
continue performing sit to stands until they feel they are unable to do anymore. 
This number will be collected as their maximum sit to stand score.  
• Short Physical Performance Battery. It comprises a summary of three separate 
measures (maximum of 4 points for each component): gait speed, balance, 
and timed repeated chair stands. This test requires the assessment of walking 
speed (time to walk 3 meters), a balance test (standing in 3 different positions 
for 10 seconds each-tandem, semi tandem, and side by side), and the time it 
takes to sit and stand 5 times in a chair (see above). Scoring is based on a 
scale of 0-12, lower numbers representing worse performance. Patients who 
cannot complete the test will receive a predetermined score or “0” that 
represents “not able”.  The Short Physical Performance Battery takes 
approximately 2–3 minutes to complete in the outpatient clinic setting.1RM leg 
press strength testing: Patients will perform a warm-up set of 10 repetitions of 
a leg press at estimated 50% of 1RM, followed by a set of 5 repetitions at 
estimated 70% of 1RM, and a set of 3 repetitions at estimated 80% of 1RM. 
Subjects then incrementally increased the weight after each successful 1RM 
attempt, defined as controlling the movement through the entire concentric and 
eccentric motions. 1RM was determined to be the most weight lifted one time 
after three consecutive failures of an increased weight (Protocol approved in 
study #2017-1016) 
• Patients in the exercise arm will be assessed for their maximum weight lifted 
during a training session at baseline, 6 months, and 12 months. This data is a 
cumulated number of all weight lifted during all exercises and repetitions 
performed in a single training session (60 minutes). 
• Brachial FMD will be used to assess macrovascular endothelial function. This 
method involves the measurement of vascular reactivity of the brachial artery 
using non-invasive ultrasound technique. While the subject rests in the supine 
position, an 11 MHz probe will be used to determine brachial artery diameter 
above the antecubital fossa in the non-dominant arm. In addition, continuous 
wave Doppler will be used to determine brachial artery blood flow velocity. 
Brachial artery diameter and blood flow velocity will be measured under the 
following conditions: 1) At rest, 2) During reactive hyperemia produced by a 
five minute interruption of flow with a blood pressure cuff inflated >50mmHg 
above systolic pressure, 3) For three minutes after reactive hyperemia (30-
second intervals for the first minute and 1-minute intervals thereafter).  
 
• Assessment of vascular stiffness using peripheral tonometery and ultrasound 
imaging 

 ____________________________________________________________________________________________ 
Exercise and dialysis, version: 24 
Date: 07/25/2023 
Page 10 of 60 
 
• Upon entering the lab, participants will be required to rest quietly in the supine 
position in a dimly lit room for 10 minutes.  Arterial size and stiffness will then 
be measured via ultrasonography using several different methodologies:   1) 
Pulse wave velocity:  this test allows for a non-invasive way to measure 
arterial stiffness.  Three disposable electrodes will be placed on the subject's 
torso.  A pen-shaped transducer is placed over the carotid artery (side of the 
neck), over the femoral artery (top of the leg), over the anterior tibialis artery 
(inner ankle), and over the radial artery (wrist).  The distance between each of 
these sites will be measured using a tape-measure.   2) Arterial Distensibility 
and function by ultrasound imaging:  this test allows for non-invasive imaging 
of the carotid, brachial, and femoral arteries.  Central blood pressure will be 
determined using the aforementioned pulse-wave analysis method 
(SphygmoCor SCOR, PWV Medical, Sydney, Australia).  In brief, the pressure 
waveforms that are obtained at the radial artery site are subjected to a 
generalized transfer function to derive the corresponding central arterial 
waveforms 
 
• Cardio-ankle vascular index (CAVI) and Ankle Brachial Index (ABI) 
CAVI and ABI will be assessed by pulse wave velocity analysis at the brachial 
and ankle arteries (VaSera VS 1500AU, Fukuda Denshi, Japan). The CAVI 
measurement requires the placement of ECG electrodes on both wrists, and a 
microphone for phonocardiography on the sternum in the second intercostal 
space, and 4 blood pressure cuffs.  CAVI between the heart and ankle arteries 
is assessed using measurements oftime between heart sound II and 
plethysmograms taken at the brachial 
and ankle arteries. This will be done to measure the stiffness of arteries and is 
independent of blood pressure.  
• Wrist Artery Stiffness 
A very sensitive pen-shaped microphone will be placed on the subject’s wrist 
(radial artery).  This microphone measures how stiff the radial artery is.   
 
• Central Artery Stiffness 
The same pen-shaped microphone used before will be placed on  the subject’s 
neck and then the artery at the top of their thigh.  We will use these  
measurements to measure how stiff their central arterial system (the arteries in 
the midsection of the body) is.  
   
• Carotid Artery Stiffness and Compliance 

 ____________________________________________________________________________________________ 
Exercise and dialysis, version: 24 
Date: 07/25/2023 
Page 11 of 60 
 
We will look at the artery in the subject’s neck using an ultrasound 
machine.  This machine is similar to what doctors use to look at babies within 
the womb.  We will place a small amount of gel on their neck to help us get a 
clearer picture.  This gel is hypoallergenic and washes off very easily.  We will 
place the probe on their skin, over the artery on the inside of their right 
neck.  This probe will allow us to look at the carotid artery and see how it 
moves with each heart beat.   
 
• Cardiac Ultrasound 
We will measure the subject’s heart function with ultrasonography using 
ultrasound gel and a probe that will be placed on the chest area.  It is the 
same probe used to visualize babies in the womb.  We will measure how 
quickly the subject’s heart contracts and relaxes.   
 
• Near Infrared Spectrometry (NIRS) 
We will measure the presence of oxygen in the muscle by using a simple and 
noninvasive method called near infrared spectrometry (NIRS). NIRS non-
invasively measures muscle oxygenation by measuring oxygenated, 
deoxygenated and total hemoglobin. It can monitor changes in muscle 
oxygenation and blood flow during submaximal and maximal exercise by using 
sensors placed on the forearm, with the signal corrected for skinfold thickness. 
During exercise, the extent to which skeletal muscles deoxygenate varies 
according to the type of muscle, type of exercise and blood flow response.  
 
• Optional muscle biopsies 
We will offer an optional muscle biopsy to subject’s in both intervention and 
control arms, at baseline and at 12 month post-intervention. This biopsy will be 
performed to measure expression of mature microRNAs using total RNA 
extraction, which will help evaluate how targeted exercise may change muscle 
development.  The muscle biopsy will be performed by a surgeon approved to 
be on this study as research personnel. All surgeons are experienced 
surgeons with prior experience performing muscle biopsies. The muscle 
biopsy will be performed at the University of Illinois at Chicago Outpatient 
Clinic, with an address at 1855 W Taylor St, Chicago, IL 60612.   
The patient will be asked to remove the clothes around the site of the biopsy. They will 
need to lie as still as possible. The skin will be disinfected and a small 2 cm incision 
made with a sterile #11 surgical blade will be made over the existing scar located on the 
bicep or forearm of the patient.  The scar tissue is in reference to when the patient was 
on hemodialysis or had a forearm graft (prior to transplantation). The area will be 

 ____________________________________________________________________________________________ 
Exercise and dialysis, version: 24 
Date: 07/25/2023 
Page 12 of 60 
 
infiltrated with approximately 4 mL of lidocaine (2%) with special attention to ensure that 
no lidocaine is injected in the muscle. Thus, injection of lidocaine is done superficially 
and obliquely. After the 2 cm incision and the muscle tissue is visualized, a cut will be 
made. Muscle fibers are carefully dissected in their longitudinal axis away from the 
tendon insertion, to obtain a sample of 300 mg. This is about the size of 4-5 grains of 
rice. Both ends are immediately clipped and hemostasis is controlled. The bundle is 
fixed on a cork support at its apparent resting length. This will be completed twice for a 
sample total of 600 mg. After the samples have been retrieved, pressure will be applied 
to the incision site and then it will be cleaned.  After cleaning the incision, the site will be 
stitched with sutures, and then bandaged with nonstick gauze and a protective dressing. 
This procedure will take approximately 30 minutes to complete.  
Blood Markers 
• All patients will be monitored for fasting plasma Glucose, serum creatinine and 
eGFR during the study per standard of care for dialysis patients. These 
records will be obtained from patient’s medical records. This assessment will 
be performed at baseline, 6 months, and 12 months  
Counseling  
• All patients will be counseled regarding weight loss per standard of care which 
consists of a dialysis nutrition evaluation and education. 
Employment Status 
• Employment status will be assessed through patient response at baseline, 6 
months and 12 months. 
 
Other measurements: Height and weight will be measured and body mass index will 
be calculated as weight (kg) divided by height (m) squared. Employment status will be 
confirmed. Age and race will be asked for additional descriptive. 
Intervention Arms Only: Exercise Training Visits (Including the 12-Month 
Randomized Trial and PPKT Subgroup): 
Exercise Training Visits (GH Method session): 
• Patients will attend 2 trainings sessions a week for 12 months (96 visits total) 
or 36 visits for the PPKT Group (about 4.5 months).The first four sessions in 
the 12-Month Randomized Trial (over 2 weeks) for any patient will be 75 
minutes.  Following the first 4 sessions, ongoing patients will be slotted into 
recurring 60 minute time slots for the remaining weeks for both the 12-Month 
Randomized Trial and the PPKT Subgroup. Additional time will be added for 
PPKT Subgroup surveys/assessment days. All of these visits will occur in the 
UIC Disability Health and Social Policy Building (DHSP) located at 1640 W. 
Roosevelt Road in Suites 158, 190, and 195 and/or Specialty Care Building, 

 ____________________________________________________________________________________________ 
Exercise and dialysis, version: 24 
Date: 07/25/2023 
Page 13 of 60 
 
Transplant Rehab Gym, 1006, 1009 S. Wood St., Chicago, IL 60612 and/or 
GhFitlab, located at 1527 Waukegan Rd, Glenview, IL 60025. 
• For the 12-Month Randomized Trial and the PPKT Subgroup, at least twice 
per week, GH personnel will attempt to follow-up with patients via text 
message, email or a phone call to evaluate their physical recuperation and 
overall health and energy or to track their performance with a behavior change 
goal. 
• The PPKT Subgroup will include 36 visits of exercise rehabilitation intervention 
twice a week, for roughly 1 hour.  At the patient’s initial (baseline), 8th, 12th, 
16th, 24th, 32nd, and 36th visit additional time of roughly 30 minutes-1 hour 
will be added for patients to also complete survey/assessments, called the 
PAM Survey, PHQ-9 screening and the Frailty Score. We will also need to 
review medical history, lab/surgical/pathology reports in the EMR. The PAM 
Survey is a 13-item survey that assesses an individual’s knowledge, skills and 
confidence integral to managing one’s own health and healthcare.  The PHQ-9 
screening is a multipurpose instrument for screening, diagnosing, monitoring 
and measuring the severity of depression. The Frailty Score measures 
increased vulnerability to adverse health outcomes. All visits will occur at the 
Specialty Care Building, Transplant Rehab Gym, Suite 1006, 1009 S. Wood 
St., Chicago, IL 60612, and/or UIC Disability Health and Social Policy Building 
(DHSP) located at 1640 W. Roosevelt Road in Suites 158, 190, and 195, 
and/or GhFitlab, located at 1527 Waukegan Rd, Glenview, IL 60025. 
Video recording (optional) 
• Video recordings will be an option on the consent form for patients that are 
randomized into the GH exercise arm. The option to be video recorded by the 
GH team at the beginning and end of the patient’s 12 months of training.  The 
recordings will be used to compare the progress of the patient from the 
beginning and end of GH training.   The video recording will be accessed only 
by research staff. Patients will be ensured that the video recording is optional. 
 
Consent Addendum (optional) 
• 
In a separate consent addendum, enrolled patients will be asked if they would 
like provide their written permission to allow the GH team, and research staff 
to take photographs, or produce videotapes, or other types of media 
productions that capture their name, voice and/or image, and used for, but is 
not limited to: 
o Medical and/or educational training 
o Study Recruitment  
o Presentations and/or Publications 
o Fundraising  

 ____________________________________________________________________________________________ 
Exercise and dialysis, version: 24 
Date: 07/25/2023 
Page 14 of 60 
 
o Websites and social media 
  Patients will be ensured that the items included in the consent addendum are optional 
and will not affect their current study participation. Patients will be approached to sign 
the consent addendum at a study or exercise visit.  
 
Patients will be asked to complete a regimen based on the following: 
 
Summary of GH Study Visits: 
• Patients may be asked to repeat previous weeks and/or skip a particular week 
depending on their energy, progress, and overall health.  
• Depending on a patient’s individual physical need, mobility, the program may be 
slightly modified (number of repetitions, number of exercises, etc...) to be safe 
and appropriate for that individual. 
• Each week comprises two different exercise days, each incorporating 
approximately 5-10 minute light warm-up plus stretching and then the exercises. 
• Unless specified as a cardio or endurance week, all weeks consist of basic 
strength training/resistance workouts. 
• The attached exercise list (Table B) includes all possible strength training 
exercises, and clients complete the appropriate exercises for that week during 
their two, one-hour appointments each week.  Depending on a patients particular 
physical health (e.g. shoulder problems) certain exercises may be eliminated or 
modified in terms of the safe range of motion and intensity. 
• These sessions can be directly supervised by the GH instructors or performed by 
trained personnel implementing written instructions given by the instructors.   
 
3 Year Long-Term Follow Up (12 Month Randomized Trial Intervention and 
Control Arms): 
 
Patients in both the control arm and the intervention arm will be followed for 3 years 
as a way to observe maintenance of exercise (if in exercise arm), employment 
status, and quality of life status.  Patients will be called annually and asked a 
series of questions.  The annual follow up phone script is attached.  
Table B. – Complete 12 Month Training (PPKT Subgroup will stop at 18 
weeks). 
Week 
Overview 
Intensity/Weight Breaks 
Week 1 
1st Set:  30 Seconds with Only 
Safety Instruction 
2nd Set:  90 Seconds with 
More Focus on Form 
Light 
2 or more 
minutes 
Week 2 
1st Set:  Holding at top and 
bottom of range (20 seconds 
each hold) 
2nd Set:  20 rep’s and possible 
to add plus 5 depending on 
energy 
Light 
2 or more 
minutes 

 ____________________________________________________________________________________________ 
Exercise and dialysis, version: 24 
Date: 07/25/2023 
Page 15 of 60 
 
Week 3 
1st Set:  Warm-Up of 15 
repetitions 
2nd Set:  Resistance focused 
60 seconds, possible plus 5 
Light/Moderate 
2 or more 
minutes 
Week 4 
3 Sets for every exercise.  
Each set is 12 repetitions with 
some holding for five 
seconds.   
Moderate 
30 seconds 
between sets.  2 
minutes 
between 
exercises. 
Week 5 
1 Warm Up Set of 15 
repetitions. 
1 Heavier Set of 11 
Repetitions. 
Moderate/Heavy 3 minute breaks 
Week 6 
Cardio Exercises (e.g. run in 
place).  5 different exercises 
are done as one round and 
two rounds total. 
Light/Moderate 
2 minutes 
between 
exercises and 4 
minutes 
between rounds. 
Week 7 
1st Set:  Warm up of 12 
repetitions. 
2nd Set: 6 repetitions 
Moderate/Heavy 3 minutes 
Week 8 
1 Set:  90 seconds 
Light 
3 minutes 
Week 9  1 Warm Up Set of 15 
Repetitions. 
3 Sets of 6-8 repetitions 
(depending on exercise) 
Moderate/Heavy 3 minutes 
Week 
10 
3 Sets of Declining Heaviness 
with 6 reps, 8 reps, and 10 
reps 
Moderate 
3 minutes 
Week 
11 
2 Sets Per Exercise without 
break between:  18 reps and 
16 reps 
Moderate/Light 
2 minutes 
Week 
12 
1 Set of 25 - 30 repetitions 
Moderate/Light 
2 minutes 
Week 
13 
Cardio Exercises (e.g. run in 
place).  7 different exercises 
are done as one round and 
three rounds total. 
Moderate 
2 - 3minutes 
Week 
14 
1 Set of 12 - 16 Repetitions 
Moderate 
2 minutes 
Week 
15 
3 Sets of declining heaviness 
with 8, 10 and 12 repetitions 
Moderate 
3 minutes 
Week 
16 
3 Exercises in Each Set and 7 
sets 
Moderate 
3 minutes 

 ____________________________________________________________________________________________ 
Exercise and dialysis, version: 24 
Date: 07/25/2023 
Page 16 of 60 
 
Week 
17 
1 Set 90 Seconds 
Moderate/Light 
3 minutes 
Week 
18 
Cardio Exercises (e.g. run in 
place).  3 different exercises 
per set.  3 Sets equal one 
Round.  Three Rounds total 
Light 
2 minutes 
Week 
19 
1 Warm-Up Set of 12 
repetitions 
1 Set of 7 Repetitions 
Moderate/Heavy 3 Minutes 
Week 
20 
1 Set of 25 - 30 Repetitions 
Moderate 
3 Minutes 
Week 
21 
1st Set:  Warm up of 12 
repetitions. 
2nd Set: 6 repetitions 
Moderate/Heavy 3 minutes 
Week 
22 
1 Set:  35 - 40 repetitions  
Moderate/Light 
3 minutes 
Week 
23 
1 Warm Up Set:  15 
repetitions 
1 Heavier Set 8 - 10 
repetitions 
Moderate/Heavy 3 minutes 
Week 
24 
1 Set of 90 Seconds focused 
on resistance 
Moderate 
3 minutes 
Week 
25 
Cardio Exercises.  10 
exercises in a set.  2 Sets. 
Moderate 
3 minutes 
Week 
26 
3 Exercises in 1 Set.  9 Sets. 
Moderate 
3 minutes 
Week 
27 
1 Warm Up Set:  8 – 12 reps. 
1 Heavy Set:  8 – 12 reps.  
Slower Speed. 
Moderate/Heavy 2 minutes 
Week 
28 
1 Warm Up Set 8 reps 
1 Heavy Set 8 reps.  Medium 
speed. 
Heavy 
3 minutes 
Week 
29 
3 Sets on each exercise of 6, 
8, 12 repetitions. Lower 
weights each set.  Medium 
speed. 
Moderate 
3 minutes 
Week 
30 
1 set 90 seconds.  Medium 
speed. 
Lighter 
2 minutes 

 ____________________________________________________________________________________________ 
Exercise and dialysis, version: 24 
Date: 07/25/2023 
Page 17 of 60 
 
Week 
31 
1 Warm Up Set:  8 – 12 reps. 
1 Heavy Set:  8 – 12 reps.  
Slower Speed. 
Moderate/Heavy 2 minutes 
Week 
32 
3 Sets on each exercise of 6, 
8, 12 repetitions. Lower 
weights each set.  Medium 
speed. 
Moderate 
3 minutes 
Week 
33 
1 set 90 seconds.  Medium 
speed. 
Lighter 
2 minutes 
Week 
34 
1 Warm Up Set:  8 – 12 reps. 
1 Heavy Set:  8 – 12 reps.  
Slower Speed. 
Moderate/Heavy 2 minutes 
Week 
35 
3 Sets on each exercise of 6, 
8, 12 repetitions. Lower 
weights each set.  Medium 
speed. 
Moderate 
3 minutes 
Week 
36 
1 set 90 seconds.  Medium 
speed. 
Lighter 
2 minutes 
Week 
37 
1 Warm Up Set:  8 – 12 reps. 
1 Heavy Set:  8 – 12 reps.  
Slower Speed. 
Moderate/Heavy 2 minutes 
Week 
38 
2 Sets Per Exercise without 
break between:  18 reps and 
16 reps 
Moderate/Light 
2 minutes 
Week 
39 
3 Sets on each exercise of 6, 
8, 12 repetitions. Lower 
weights each set.  Medium 
speed. 
Moderate 
3 minutes 
Week 
40 
1 set 90 seconds focused on 
resistance.  Medium speed. 
Lighter 
2 minutes 
Week 
41 
Cardio Exercises.  10 
exercises in a set.  2 Sets. 
Moderate 
3 minutes 
Week 
42 
1 Warm Up Set:  8 – 12 reps. 
1 Heavy Set:  8 – 12 reps.  
Slower Speed. 
Moderate/Heavy 2 minutes 
Week 
43 
3 Sets on each exercise of 6, 
8, 12 repetitions. Lower 
weights each set.  Medium 
speed. 
Moderate 
3 minutes 

 ____________________________________________________________________________________________ 
Exercise and dialysis, version: 24 
Date: 07/25/2023 
Page 18 of 60 
 
Week 
44 
1 set 90 seconds focused on 
resistance.  Medium speed. 
Lighter 
2 minutes 
Week 
45 
1 Warm Up Set:  8 – 12 reps. 
1 Heavy Set:  8 – 12 reps.  
Slower Speed. 
Moderate/Heavy 2 minutes 
Week 
46 
3 Sets on each exercise of 6, 
8, 12 repetitions. Lower 
weights each set.  Medium 
speed. 
Moderate 
3 minutes 
Week 
47 
1 set 90 seconds focused on 
resistance.  Medium speed. 
Lighter 
2 minutes 
Week 
48 
1 Warm Up Set:  8 – 12 reps. 
1 Heavy Set:  8 – 12 reps.  
Slower Speed. 
Moderate/Heavy 2 minutes 
Week 
49 
3 Sets on each exercise of 6, 
8, 12 repetitions. Lower 
weights each set.  Medium 
speed. 
Moderate 
3 minutes 
Week 
50 
1 set 90 seconds focused on 
resistance.  Medium speed. 
Lighter 
2 minutes 
Week 
51 
1 Warm Up Set 8 reps 
1 Heavy Set 8 reps 
Heavy 
3 minutes 
Week 
52 
Cardio Exercises.  10 
exercises in a set.  2 Sets. 
Moderate 
3 minutes 
 
Table C.  
GH Method:  List of Strength/Resistance Exercises 
MEN   
 
 
 
 
 
 
WOMEN  
Exercise 
Exercise 
Chest:  Smith Bench Press/Incline 
Glutes:  Abductor 
Glutes:  Abductor 
Biceps:  Cable Easy Curl / Free 
Bar 
Biceps:  Cable Easy Curl/Free Bar 
Quads:  Leg Extension 
Quads:  Leg Extension 
Chest:  Smith Press 
Calves:  Calf Machine 
Abs:  Decline  
Biceps:  Preacher 
Quads:  Leg Press 
Quads:  Leg Press 
Back:  Pull Down Behind 
Quads:  Leg Extension 
Hamstring:  Machine  
Abs:   Decline 
Shoulders:  Dumbbell Press / 
Smith Press 

 ____________________________________________________________________________________________ 
Exercise and dialysis, version: 24 
Date: 07/25/2023 
Page 19 of 60 
 
Back:  Pull Down Behind 
Triceps:  Push Down / Kick Back / 
Rope Pull down 
Hamstring:  Curl Machine 
Back:  Low Roll  
Shoulders:  Dumbbell Press / Smith Press 
Abs:  Sit-Ups  
Back:  Low Roll  
Shoulders:  Side Raise with 
Dumbbells 
Hamstring:  Good Morning with Dumbbell/ 1 
Leg Hamstring Curl 
Triceps:  Close Grip 
Shoulders:  Side Rise with Dumbbells 
Hamstring:  Good Morning with 
Dumbbells/1 Leg Hamstring 
Triceps:  Push Down / Kick Back 
Triceps:  Push Down / Kick Back 
Abs:  Sit Ups 
Abs:  Sit Ups 
Triceps:  Close Grip 
Triceps:  Close Grip 
 
Study Visit Flow Chart 12-Month Randomized Trial: 
 
 
 
 
 
 
 
 
 
 
7.0 
Use of Patient Completion Story Videos 
 
The inclusion of patient completion story videos and website screenshots for 
ghfitlab.com and UIC transplant donation page (will help support the study and may 
increase enrollment) will be used for, but are not limited to: recruitment, medical and/or 
education training, websites and social media, etc. These videos will include identifiable 
patient information. All patients that will be included will signed the consent addendum 
for the use and disclosure of protected health information for photo, video, interview, 
and media. IRB approval will be obtained prior to use of videos. Videos will be uploaded 
to Vimeo for sharing. We would like the option to share these videos on social media 
platforms, such as, Facebook, Instagram, LinkedIn, and also share them on the ghfitlab 
website and the UIC donation website. We have created a UIC website script.  
 
 
 
8.0 Expected Risks/Benefits 
 
Baseline: All 
Data Collection 
Measures Listed 
Above 
12 months: All 
Data Collection 
Measures Listed 
Above 
Throughout: Exercise rehabilitation sessions (details listed above); 2 days/week; 1 hour/session 
*PPKT Subgroup does not have separate study visits. All data collected will be included in exercise 
visits.  
6 months: All Data 
Collection Measures 
Listed Above  

 ____________________________________________________________________________________________ 
Exercise and dialysis, version: 24 
Date: 07/25/2023 
Page 20 of 60 
 
The main risk of this research is loss of confidentiality of medical information for both 
the 12-Month Randomized Trial and the PPKT Subgroup.  Consent will be obtained for 
all patients. Master patient code list will be kept in a separate file accessible only by the 
primary investigator. A member of the UI healthcare team will be available to answer 
any questions or discuss any concerns that patients may have.  The patient may also 
experience mild anxiety or discomfort in providing information via questionnaires about 
their health and well-being. The patient may also have a potential to feel anxiety when 
being video recorded (if applicable).  
 
Risks associated with the consent addendum for both the 12-Month Randomized Trial 
and the PPKT Subgroup:   
The main risk is loss of confidentiality. Patients may also have a potential to feel anxiety 
when we take photographs, videotapes, or other types of media productions that 
capture their name, voice and/or image. 
 
Risk associated with grip strength (Dynomometer) (12-Month Randomized Trial and the 
PPKT Subgroup) and 1RM tests include (12-Month Randomized Trial only):  
Shortness of breath, fatigue, strains, sprains, and muscle soreness.  
 
Risks associated with physical activity including 3 meter walk, sit to stand, and short 
performance battery tests includes (12-Month Randomized Trial only): 
Fatigue, being out of breath, muscle soreness, heart rhythm irregularities, dizziness, 
loss of consciousness and even death.  However, serious adverse events (side effects) 
are very rare and by careful screening and monitoring during the test, the risks of such 
events are minimized.  Further risks include slips and trips possibly resulting in ankle 
sprains and falls.  These risks will be minimized by having a research assistant within 
arm’s reach for stability.  All personnel assisting in testing are trained in CPR and 
emergency lab procedure. 
 
Risks associated with radiation exposure from the DEXA scan (12-Month Randomized 
Trial only): 
The patient will be exposed to a radiation dose of less than or equal to 0.3 mrem based 
upon manufacturer’s specifications and pre-determined calculations.  This amount of 
radiation exposure is minimal given the estimated effective equivalent dose is below 
100 mrem per year, a limit set by the Nuclear Regulatory Commission for “general 
public” exposure. 
 
Risks associated with vascular function, vascular stiffness, NIRS, and cardiac 
ultrasound measures (12-Month Randomized Trial only):  

 ____________________________________________________________________________________________ 
Exercise and dialysis, version: 24 
Date: 07/25/2023 
Page 21 of 60 
 
There are no known risks associated with the ultrasound tests used to measure artery 
stiffness and heart function.  Because we will need to place 3 electrodes on the skin to 
measure heart rate during these procedures, we may need to shave the area on males 
where these will be placed which may cause some discomfort and/or redness. Some 
adhesive may remain once electrodes are removed which may cause redness. This 
should wear off within 1-8 hours. For the assessment of endothelial function (FMD) & 
NIRS, the act of inflating a blood pressure cuff around the arm for five minutes before 
deflation may cause some discomfort, temporary numbness, or tingling. These 
discomforts, however generally last for a minimal amount of time post deflation. 
 
Risks associated with the muscle biopsy (12-Month Randomized Trial only)::  
Bleeding, bruising, and infection at the procedure site. A subfascial hematoma (a pocket 
of blood that forms beneath the fatty layer of the skin next to the muscle) may occur. 
Medical conditions or use of medications or supplements that causes excessive 
bleeding creates a higher risk of bleeding from the procedure site. Less common risks 
include muscle contracture (shortening of the muscle) and nerve damage leading to 
loss of feeling at or around the procedure site. Arm may be tender or sore for 2 to 3 
days post biopsy.  It is not uncommon to have a patch of numbness around the scar 
which may last for a few weeks.    
 
Risks associated with lidocaine use (12-Month Randomized Trial only):  
Common side effects of lidocaine include site pain, feeling lightheaded, shaking, low 
blood pressure, drowsiness, confusion, weakness, blurry or double vision, and 
dizziness. Serious reactions such as seizures, abnormal heart beats, slow heartbeat, 
heart block, severe allergic reactions, respiratory arrest (ending of normal breathing), 
and coma (a state deep unconsciousness that lasts for a prolonged or indefinite period) 
have occurred. 
 
 
 
9.0 
Data Collection and Management Procedures 
Data from questionnaires, demographics and laboratory data will be obtained from 
EPIC, the electronic medical record, as well as all other data collection points will be 
collected on paper forms and transferred and kept in an excel database. Data collected 
will be used for research purposes for future publications, presentations and posters (if 
applicable) in order to analyze the outcomes. Record of data will be locked and stored 
in an electronic data file stored on hospital H and N drive using sequential, numeric 
code (001, 002, 003, etc.) on a password-protected computer in a locked office . Master 
key linking code with patient name will be held in a separate file accessible only to the 
PI.  Limited access will be given to IRB approved study team members. Data master list 

 ____________________________________________________________________________________________ 
Exercise and dialysis, version: 24 
Date: 07/25/2023 
Page 22 of 60 
 
will be locked in suite 840 South Wood Street, Suite 617 Clinical Sciences North 
Building Chicago, IL 60612-7316. Additional data collection excel documents are being 
kept at 1640 W. Roosevelt Rd, Chicago IL, 60608. Only investigator and co-
investigators will have access to study data. 
 
 
10.0 Data Analysis 
The de-identified collected data will be entered into a SAS database. Initial descriptive 
analysis will include calculating means, standard deviations, ranges and frequencies. T-
tests for continuous variables and Chi Square or Fischer exact tests of association for 
categorical variables will be used to compare results of the study between the two 
groups for the efficacy parameters listed above. A P value<0.05 will be considered 
significant. 
 
11.0 Data and Safety Monitoring 
This protocol is not a drug or device research study, and for that reason, monitoring by 
a Data Safety Monitoring Board is not required at this time.  
  
All adverse events related to the physical therapy of the research will be reported 
promptly to the IRB. If a breach of patient privacy/confidentiality, occurs that the study 
PI views as greater than a minor occurrence, the IRB will be notified of such at the time 
of discovery and a mitigation plan will be developed in consultation with the IRB. 
Problems and adverse events will be identified by the investigator or co-investigator 
based on patient self-reporting at each visit and will be reported to the IRB when 
applicable per IRB policy. Patients have the right to withdraw from (i.e., discontinue 
participation in) research at any time. If a patient decides to withdraw from all 
components of a research study, the investigator will discontinue all research activities 
involving that patient’s participation in that study. 
 
 
11.1  Monitoring and Reporting AE & SAEs 
The investigator will monitor participants for the occurrence of adverse events during 
the course of the study. The investigator will instruct subjects prior to transplantation 
to report any physical changes or new symptoms that they notice during the course of 
the study. 
 
Physicians and health care personnel involved in the subject’s medical care will be 
instructed to report all serious adverse events (defined above) as soon as possible to: 
 
Enrico Benedetti, MD  

 ____________________________________________________________________________________________ 
Exercise and dialysis, version: 24 
Date: 07/25/2023 
Page 23 of 60 
 
Department of Surgery 
University of Illinois 
840 South Wood Street, Suite 402 (MC958) 
Chicago, IL 60612 
Tel: 312 355-1493 
Email: enrico@uic.edu 
 
When an SAE is considered reportable to regulatory agencies, Dr. Benedetti will 
prepare the initial report and forward copies the Institutional Review Board (IRB) within 
the appropriate timeframe delegated by the IRB. Serious events will be followed until 
resolved or considered stable. The following attributes must be assigned: description, 
date of onset and resolution (if known when reported), severity, assessment of 
relatedness to test therapy, and action taken.  
 
12.0 Statistical Considerations 
The efficacy of the methods will be determined by: 
  
1. a significant difference in term of pre and post treatment perception of well-being 
between the arms/groups 
   
2.a  significant difference in the lean/fat body mass ratio between the arms/groups 
  
3. a significant difference in BMI between the arm/groups 
                                                            
4. a significant difference between the metabolic parameters between the arms/groups 
  
The data will be entered into an Excel spreadsheet and stored on the UIMCC hospital 
server. The patient data, including age, sex, race, underlying kidney disease, length of 
hospital stay, rejection episode, comorbidities, and medications will be coded and 
patient names will not be included in the datasheet.  
 
The de-identified collected data will be entered into a SAS database. Initial descriptive 
analysis will include calculating means, standard deviations, ranges and frequencies. T-
tests for continuous variables and Chi Square or Fischer exact tests of association for 
categorical variables will be used to compare results of the study between the two 
arms/groups for the efficacy parameters listed above. A P value<0.05 will be considered 
significant. 
 
13.0 Regulatory Requirements 
13.1 Informed Consent  
This will occur in the surgery clinic at University of Illinois at Chicago Medical 
Center. Patients will be seen in clinic based on standard of care appointments 

 ____________________________________________________________________________________________ 
Exercise and dialysis, version: 24 
Date: 07/25/2023 
Page 24 of 60 
 
without any relation to the study.  Patients may also be recruited using a patient 
video that they have seen on social media, ghfitlab website or UIC website. After 
being identified, the potential subject will be approached by one of the key 
personnel who is approved to consent. This person will explain the study and 
answers all questions. It will be reinforced that participation is completely 
voluntary and the subject’s decision will not affect their relationship with the 
treating physician from the Department of Surgery.  
 
In addition to the above, we will also consent Spanish speakers using a Spanish 
consent, phone script and questionnaires for the main 12-Month Randomized 
Trial. This will allow us to also consent Spanish patients that may not have been 
able to understand the English consent. Some of our Co-Investigators are native 
Spanish speakers and will be able to go over the Spanish documents with the 
patient thoroughly and will be able to answer any additional questions or 
comments. A Spanish speaker will also be present at all of the subjects’ visits.  
 
13.2 Subject Confidentiality  
The medical and research record will be confidential to the extent permitted by 
law. Study subjects will be identified by a code for the research records which will 
be stored on a password protected computer in the principal investigators office.  
Personal information from research records will not be released without written 
permission by the subject except: 
- 
If necessary to protect the subject’s rights and welfare (for example, if the 
subject is injured and needs emergency care or when the UIC Institutional 
Review Board monitors the research or consent process) 
- 
If required by law 

 ____________________________________________________________________________________________ 
Exercise and dialysis, version: 24 
Date: 07/25/2023 
Page 25 of 60 
 
14.0 REFERENCES 
 
1. Fondahn, E., Hahn, H., Schnitzler, M., & Miller, B. (2003). Perceived Exercise 
Benefits and Barriers in Hemodialysis Patients. Hemodialysis International, 7(1), 
73-104. doi:10.1046/j.1492-7535.2003.01275. 
2. Tentori, F., Elder, S. J., Thumma, J., Pisoni, R. L., Bommer, J., Fissell, R. B., . . . 
Robinson, B. M. (2010). Physical exercise among participants in the Dialysis 
Outcomes and Practice Patterns Study (DOPPS): correlates and associated 
outcomes. Nephrology Dialysis Transplantation, 25(9), 3050-3062. 
doi:10.1093/ndt/gfq138 
3. Zheng, J., You, L., Lou, T., Chen, N., Lai, D., Liang, Y., . . . Zhai, C. (2010). 
Development and psychometric evaluation of the Dialysis patient-perceived 
Exercise Benefits and Barriers Scale. International Journal of Nursing 
Studies,47(2), 166-180. doi:10.1016/j.ijnurstu.2009.05.023 
4. Roshanravan, B., Gamboa, J., & Wilund, K. (2017). Exercise and CKD: Skeletal 
Muscle Dysfunction and Practical Application of Exercise to Prevent and Treat 
Physical Impairments in CKD. American Journal of Kidney Diseases, 69(6), 837-
852. doi:10.1053/j.ajkd.2017.01.051 
5. Zuo, M., Yue, W., Yip, T., Ng, F., Lam, K., Yiu, K., . . . Lo, W. (2013). Prevalence 
of and Associations With Reduced Exercise Capacity in Peritoneal Dialysis 
Patients. American Journal of Kidney Diseases, 62(5), 939-946. 
doi:10.1053/j.ajkd.2013.05.016 
6. Quint EE, Zogaj D, Banning LBD, Benjamens S, Annema C, Bakker SJL, 
Nieuwenhuijs-Moeke GJ, Segev DL, McAdams-DeMarco MA, Pol RA. Frailty and 
Kidney Transplantation: A Systematic Review and Meta-analysis. Transplant 
Direct. 2021 May 18;7(6):e701. doi: 10.1097/TXD.0000000000001156. PMID: 
34036171; PMCID: PMC8133203. 
7. Porrini E, Delgado P, Bigo C, Alvarez A, Cobo M, Checa MD, et al. Impact of 
metabolic syndrome on graft function and survival after cadaveric renal 
transplantation. Am J Kidney Dis 2006;48(1):134–42.  
8. Frih, Z. B., Boudokhane, S., Migaou, H., Salah, S., & Jellad, A. (2014). Impact of 
physical exercise in dialysis patients. Annals of Physical and Rehabilitation 
Medicine, 57. doi:10.1016/j.rehab.2014.03.1014 
9. Hamaoka T, McCully KK, Quaresima V, Yamamoto K, Chance B. Near-infrared 
spectroscopy/imaging for monitoring muscle oxygenation and oxidative 
metabolism in healthy and diseased humans. J Biomed Opt 2007;12:062105. 

 
Page 
24 of 2 
 
 
Exercise and dialysis, version: 22 
Date: 02/14/2023 
Page 26 of 60 
 
 
APPENDICES 
 
1. PAPER COLLECTION FORM: 
 
 
GH Dialysis Collection Form: 
Patient ID: 
Baseline visit date: 
6 month visit date: 
12 month visit date: 
Descriptive 
Weight : 
 
 
 
Height: 
 
 
 
Waist Circumference: 
 
 
 
BMI: 
 
 
 
Age/DOB: 
 
 
 
Gender: 
 
 
 
Race: 
 
 
 
Employment Status: 
 
Full or Part Time or Retired: 
 
 
Seeking Employment? 
School? 
 
Full or Part Time: 
 
 
 
Start of Dialysis: 
 
Years: 
Graft Arm: 
BP: 
 
HR: 
Location: 

 
Page 
24 of 2 
 
 
Exercise and dialysis, version: 22 
Date: 02/14/2023 
Page 27 of 60 
 
 
Assistive Device? 
 
 
Blood Thinners? 
 
 
 
Health History 
 
 
 
GH PPKT Subgroup Collection Form: 
Patient ID: 
Baseline visit date: 
Visit # 12 date: 
Visit # 24 date: 
Visit #36 date: 
Descriptive 
Weight : 
 
 
 
Height: 
 
 
 
Waist Circumference: 
 
 
 
BMI: 
 
 
 
Age/DOB: 
 
 
 
Gender: 
 
 
 
Race: 
 
 
 
Employment Status: 
 
Full or Part Time or Retired: 
 
 
Seeking Employment? 
School? 
 
Full or Part Time: 
 
 
 
Creatinine: 
 
 
 
Glucose: 
 
 

 
Page 
24 of 2 
 
 
Exercise and dialysis, version: 22 
Date: 02/14/2023 
Page 28 of 60 
 
 
 
GRF: 
 
 
 
Start of Dialysis: 
 
Years: 
Graft Arm: 
Transplant date:  
 
 
BP: 
 
 
Location: 
Allergies: 
 
 
Pain Average 
Location: 
 
 
 
 
PWA and PWV 
Blood Pressure 1: 
 
 
 
 
 
 
Average BP: 
 
 
 2: 
 
 
 
 
 
 
MP: 
 
 
 3: 
 
 
Central PWV Measurements: (R. Side) 
1. Carotid → sternal notch:  _________mm 
2. Sternal notch → femoral: _________mm 
                                          (2-1) =_________mm 

 
Page 
24 of 2 
 
 
Exercise and dialysis, version: 22 
Date: 02/14/2023 
Page 29 of 60 
 
 
Notes: 
cIMT and ET 
Basic Carotid (cIMT): 
Rt. Mean-IMT (mm) 
 
Carotid Strain/Strain Rate (speckle tracking) 
 
Echo Tracking (ET ): 
Arterial Stiffness 
 
Beta 
 
Ep (kPa) 
 
AC (%) 
 
Diameter 
 
D_Max (mm) 
 
D_Min (mm) 
 
DAT max (ms) 
 
DDiff (mm) 
 
PWA Radial 
Aortic SBP (mmHg) 
 
Aortic DBP (mmHg) 
 
HR (bpm) 
 
Ejection Duration (ms) 
 
Tr (ms) 
 
Aortic Augmentation 
 
Aortic AIX (%) 
 
Aortic AIX@75 (%) 
 
SEVR 
 
ESP 
 
Radial Wave Reflection 
Forward Pulse Height (mmHg) 
 
Reflected Pulse Height 
(mmHg) 
 
Reflection Index (%) 
 
Forward Pressure Peak (ms) 
 
Reflected Pressure Peak (ms) 
 
Aortic Pulse Reflection (ms) 
 
Transmission Time (ms) 
 
PWA Carotid 
SBP (mmHg) 
 
DBP (mmHg) 
 
MAP 
 
PP 
 
Pulse Wave Velocity 
Central PWV±SD 
 

 
Page 
24 of 2 
 
 
Exercise and dialysis, version: 22 
Date: 02/14/2023 
Page 30 of 60 
 
 
 
Notes: 
 
 
 
 
 
Cardiac Ultrasound 
Left Ventricular Mass 
(LVM) 
 
IVSD  
LVPW  
LVID  
Fractional Shortening  
 
Ejection Fraction (%) 
 
dP/dT 
 
Stroke Volume (mL) 
 
End Systolic Volume (mL) 
 
End Diastolic Volume (mL)  
Cardiac Output (mL) 
 
E 
 
A 
 
E/A 
 
 
Septal 
Lateral 

 
Page 
24 of 2 
 
 
Exercise and dialysis, version: 22 
Date: 02/14/2023 
Page 31 of 60 
 
 
 
Notes: 
 
FMD 
Arm: 
Location: 
 
Notes: 
 
 
NIRS 
Arm: 
Location: 
 
Notes: 
 
 
 
 
Hand Grip 
Strength 
Dominant hand 
grip strength (kg)
 
 
 
 
Hand Used: 
1 
2 
3 
Average 
 
 
Sit-To-Stand 
Time: _____sec (if five stands are completed)  
Number of Stands Completed:       1 2 3 4 5  
Chair Stand Ordinal Score: _____  
0 = unable  
S’ 
 
 
E’ 
 
 
A’ 
 
 
E’/A’ 
 
 
E/e’ 
 
 
Deceleration Time (ms) 
 
Isovolumetric Relaxation 
Time (ms) 
 
Estimated End-Diastolic 
Pressure (load est.) 
 
Ventricular arterial 
coupling:  Ea & El 
 
Electromechanical Delay 
 
Save as DICOM image to USB 
Strain/strain rate via speckle 
tracking 
 
 
Baseline Diameter 
 
Diameter Difference (%Change) 
 
Blood Flow 
 
% Saturation 
 

 
Page 
24 of 2 
 
 
Exercise and dialysis, version: 22 
Date: 02/14/2023 
Page 32 of 60 
 
 
1 = > 16.7 sec  
2 = 16.6-13.7 sec  
3 = 13.6-11.2 sec  
4 = < 11.1 sec 
  
Max Sit to Stand:__________ 
8 Foot Walk 
 
Time: _____ sec  
Gait Ordinal Score: _____  
0 = could not do  
1 = >5.7 sec (<0.43 m/sec)  
2 = 4.1-6.5 sec (0.44-0.60 m/sec)  
3 = 3.2-4.0 sec (0.61-0.77 m/sec)  
4 = <3.1 sec (>0.78 m/sec 
 
 
 
Balance: 
Side by side: 
Circle one number  
2. Held for 10 sec  
1. Held for less than 10 sec; number of seconds held _____  
0. Not attempted 
Semi Tandem 
 
Circle one number  
2. Held for 10 sec  
1. Held for less than 10 sec; number of seconds held _____  
0. Not attempted 
 
Tandem 
Circle one number  
2. Held for 10 sec  
1. Held for less than 10 sec; number of seconds held _____  
0. Not attempted 
 
Balance Ordinal Score: _____  
0 = side by side 0-9 sec or unable  

 
Page 
24 of 2 
 
 
Exercise and dialysis, version: 22 
Date: 02/14/2023 
Page 33 of 60 
 
 
1 = side by side 10, <10 sec semitandem  
2 = semitandem 10 sec, tandem 0-2 sec  
3 = semitandem 10 sec, tandem 3-9 sec  
4 = tandem 10 sec 
 
 
 
DEXA 
Percent body fat:  
 
Percent fat-free mass: 
 
(Print out attached) 
2. Questionnaires  
PROMIS: 
 
 
Global Health PROMIS® Scale v1.2  
 
 
 
Please respond to each question or statement by marking one box per row. 
 
 
 
 
Excellent 
Very 
good 
 
Good 
 
Fair 
 
Poor 
 
Global01 
 
In general, would you say your health is: ........... 
 
5 
 
4 
 
3 
 
2 
 
1 
 
 
 
Global02 
In general, would you say your quality of life 
is: .......................................................................... 
 
5 
 
4 
 
3 
 
2 
 
1 
 
 
 
 
Global03 
 
In general, how would you rate your physical 
health? ................................................................ 
 
 
5 
 
 
4 
 
 
3 
 
 
2 
 
 
1 

 
Page 
24 of 2 
 
 
Exercise and dialysis, version: 22 
Date: 02/14/2023 
Page 34 of 60 
 
 
 
 
 
 
 
Global04 
 
In general, how would you rate your mental 
health, including your mood and your ability 
to think? ............................................................. 
 
 
5 
 
 
4 
 
 
3 
 
 
2 
 
 
1 
 
 
 
 
 
Global05 
 
In general, how would you rate your satisfaction 
with your social activities and relationships? 
...................................................... 
 
 
5 
 
 
4 
 
 
3 
 
 
2 
 
 
1 
 
 
 
 
 
 
Global09r 
 
In general, please rate how well you carry out 
your usual social activities and roles. (This 
includes activities at home, at work and in your 
community, and responsibilities as a 
parent, child, spouse, employee, friend, etc.)...... 
 
 
 
5 
 
 
 
4 
 
 
 
3 
 
 
 
2 
 
 
 
1 
 
 
Completely 
 
Mostly 
 
Moderately 
 
A little 
 
Not at all 
 
 
 
Global06 
 
To what extent are you able to carry out your 
everyday physical activities such as walking, 
climbing stairs, carrying groceries, or moving 
a chair? ................................................................ 
 
 
5 
 
 
4 
 
 
3 
 
 
2 
 
 
1 

 
Page 
24 of 2 
 
 
Exercise and dialysis, version: 22 
Date: 02/14/2023 
Page 35 of 60 
 
 
 
 
In the past 7 days… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Never
 
Rarely 
Sometimes 
Often 
 
Always 
 
 
 
Global10r 
 
How often have you been bothered by 
emotional problems such as feeling 
anxious, depressed or irritable? 
......................................... 
 
 
5 
  
 
4 
 
 
 
3 
 
 
2 
  
 
1 
 
 
 
 
 
 
None 
 
 
Mild 
 
Moderate 
 
Severe
 
Very 
severe 
 
 
Global08r 
 
How would you rate your fatigue on 
average? 
.............................................................. 
 
 
5 
 
 
 
4 
 
 
 
3 
 
 
2 
 
 
 
1 
 
 
 
 
 
Global07r 
 
How would you rate 
your pain on average? 
....... 
 
 
0 
 
 
1 
 
 
2 
 
 
3 
 
 
4 
 
 
5 
 
 
6 
 
 
7 
 
 
8 
 
 
9 
 
 
10 
 
No 
pain 
 
 
 
 
 
 
 
 
 
Worst 
pain 
imaginable 
 
 
 
 

 
Page 
24 of 2 
 
 
Exercise and dialysis, version: 22 
Date: 02/14/2023 
Page 36 of 60 
 
 
 

 
Page 
24 of 2 
 
 
Exercise and dialysis, version: 22 
Date: 02/14/2023 
Page 37 of 60 
 
 
 
 

 
Page 
24 of 2 
 
 
Exercise and dialysis, version: 22 
Date: 02/14/2023 
Page 38 of 60 
 
 
 
 

 
Page 
24 of 2 
 
 
Exercise and dialysis, version: 22 
Date: 02/14/2023 
Page 39 of 60 
 
 
SF 36 
Medical Outcomes Study Questionnaire Short Form 36 Health Survey 
 
This survey asks for your views about your health. This information will help keep 
track of how you feel and how well you are able to do your usual activities. Thank 
you for completing this survey! For each of the following questions, please circle 
the number that best describes your answer. 
 
1. In general, would you say your health 
is: 
Excellent 
1 
Very good 
2 
Good 
3 
Fair 
4 
Poor 
5 
2. Compared to one year ago, 
Much better now than one year ago 
1 
Somewhat better now than one year ago 
2 
About the same 
3 
Somewhat worse now than one year ago 
4 
Much worse now than one year ago 
5 
 
3. The following items are about activities you might do during a typical day. Does 
your health now limit you in these activities? If so, how much? 
(Circle One Number on Each Line) 
 
Yes, 
Limited 
a 
Lot (1) 
Yes, 
Limited 
a 
Little 
(2) 
No, Not 
limited 
at 
All (3) 
a. Vigorous activities, such as running, lifting 
heavy objects, participating in strenuous sports 
1 
2 
3 
b. Moderate activities, such as moving a table, 
pushing a vacuum cleaner, bowling, or playing 
golf 
1 
2 
3 

 
Page 
24 of 2 
 
 
Exercise and dialysis, version: 22 
Date: 02/14/2023 
Page 40 of 60 
 
 
c. Lifting or carrying groceries 
1 
2 
3 
d. Climbing several flights of stairs 
1 
2 
3 
e. Climbing one flight of stairs 
1 
2 
3 
f. Bending, kneeling, or stooping 
1 
2 
3 
g. Walking more than a mile 
1 
2 
3 
h. Walking several blocks 
1 
2 
3 
i. Walking one block 
1 
2 
3 
j. Bathing or dressing yourself 
1 
2 
3 
 
4. During the past 4 weeks, have you had any of the following problems with your 
work or other regular daily activities as a result of your physical health? 
(Circle One Number on Each Line) 
 
Yes 
(1) 
No 
(2) 
a. Cut down the amount of time you spent on work or other 
activities 
1 
2 
b. Accomplished less than you would like 
1 
2 
c. Were limited in the kind of work or other activities 
1 
2 
d. Had difficulty performing the work or other activities (for 
example, it took extra effort) 
1 
2 
 
5. During the past 4 weeks, have you had any of the following problems with your 
work or other regular daily activities as a result of any emotional problems (such 
as feeling depressed or anxious)? 
(Circle One Number on Each Line) 
 
Yes 
No 
a. Cut down the amount of time you spent on work or other 
activities 
1 
2 
b. Accomplished less than you would like 
1 
2 
c. Didn't do work or other activities as carefully as usual 
1 
2 
 
 
6. During the past 4 weeks, to what extent has your physical 
health or emotional problems interfered with your normal 
social activities with family, friends, neighbors, or groups? 

 
Page 
24 of 2 
 
 
Exercise and dialysis, version: 22 
Date: 02/14/2023 
Page 41 of 60 
 
 
Not at all 
1 
Slightly 
2 
Moderately 
3 
Quite a bit 
4 
Extremely 
5 

 
Page 
24 of 2 
 
 
Exercise and dialysis, version: 22 
Date: 02/14/2023 
Page 42 of 60 
 
 
7. How much bodily pain have you had during the past 4 
weeks? 
None 
1 
Very mild 
2 
Mild 
3 
Moderate 
4 
Severe 
5 
Very severe 
6 
8. During the past 4 weeks, how much did pain interfere with 
your normal work (including both work outside the home and 
housework)? 
Not at all 
1 
A little bit 
2 
Moderately 
3 
Quite a bit 
4 
Extremely 
5 
 
These questions are about how you feel and how things have been with you during 
the past 4 weeks. For each question, please give the one answer that comes closest 
to the way you have been feeling. (Circle One Number on Each Line) 
 
9. How much of the time during the past 4 weeks . . . 
All of 
the 
Time 
Most 
of 
the 
Time 
A 
Good 
Bit of 
the 
Time 
Some 
of 
the 
Time 
A 
Little 
of the 
Time 
None 
of 
the 
Time 
a. Did you feel full of pep? 
1 
2 
3 
4 
5 
6 
b. Have you been a very 
nervous person? 
1 
2 
3 
4 
5 
6 
c. Have you felt so down in 
the dumps that nothing 
could cheer you up? 
1 
2 
3 
4 
5 
6 
d. Have you felt calm and 
peaceful? 
1 
2 
3 
4 
5 
6 
e. Did you have a lot of 
energy? 
1 
2 
3 
4 
5 
6 

 
Page 
24 of 2 
 
 
Exercise and dialysis, version: 22 
Date: 02/14/2023 
Page 43 of 60 
 
 
 
All 
of 
the 
Time 
Most 
of 
the 
Time 
A 
Good 
Bit of 
the 
Time 
Some 
of 
the 
Time 
A 
Little 
of the 
Time 
None 
of 
the 
Time 
f. Have you felt 
downhearted and blue? 
1 
2 
3 
4 
5 
6 
g. Did you feel worn out? 
1 
2 
3 
4 
5 
6 
h. Have you been a happy 
person? 
1 
2 
3 
4 
5 
6 
i. Did you feel tired? 
1 
2 
3 
4 
5 
6 
 
 
10. During the past 4 weeks, how much of the time has your 
physical health or emotional problems interfered with your 
social activities (like visiting with friends, relatives, etc.)? 
(Circle One Number) 
All of the time 
1 
Most of the time 
2 
Some of the time 
3 
A little of the time 
4 
None of the time 
5 
 
 
11. How TRUE or FALSE is each of the following statements for you. (Circle 
One Number on Each Line) 
 
 
Definitely 
True 
Mostly 
True 
Don't 
Know 
Mostly 
False 
Definitely 
False 
a. I seem to get sick a little 
easier than other people 
1 
2 
3 
4 
5 
b. I am as healthy as 
anybody I know 
1 
2 
3 
4 
5 
c. I expect my health to get 
worse 
1 
2 
3 
4 
5 
d. My health is excellent 
1 
2 
3 
4 
5 
 

 
Page 
24 of 2 
 
 
Exercise and dialysis, version: 22 
Date: 02/14/2023 
Page 44 of 60 
 
 
 
 
 
 

 
Page 
24 of 2 
 
 
Exercise and dialysis, version: 22 
Date: 02/14/2023 
Page 45 of 60 
 
 
KATZ INDEX OF INDEPENDENCE IN ACTIVITIES OF 
DAILY LIVING 
 
 
ACTIVITIES 
POINTS (1 OR 0) 
INDEPENDENCE: 
(1 POINT) 
NO supervision, direction or personal 
assistance 
DEPENDENCE: 
(0 POINTS) 
WITH supervision, direction, personal 
assistance or total care 
BATHING 
POINTS:  
 
(1 POINT) Bathes self completely or needs 
help in bathing only a single part of the 
body such as the back, genital area or 
disabled extremity. 
(0 POINTS) Needs help with bathing more 
than one part of the body, getting in or 
out of the tub or shower. Requires total 
bathing. 
DRESSING 
POINTS:  
 
(1 POINT) Gets clothes from closets and 
drawers and puts on clothes and outer 
garments complete with fasteners. May 
have help tying shoes. 
(0 POINTS) Needs help with dressing self 
or needs to be completely dressed. 
TOILETING 
POINTS:  
 
(1 POINT) Goes to toilet, gets on and 
off, arranges clothes, cleans genital area 
without help. 
(0 POINTS) Needs help transferring to 
the toilet, cleaning self or uses bedpan or 
commode. 
TRANSFERRING 
POINTS:  
 
(1 POINT) Moves in and out of bed or chair 
unassisted. Mechanical transferring aides 
are acceptable. 
(0 POINTS) Needs help in moving from 
bed to chair or requires a complete 
transfer. 
CONTINENCE 
POINTS:  
 
(1 POINT) Exercises complete self control 
over urination and defecation. 
(0 POINTS) Is partially or totally 
incontinent of bowel or bladder. 
FEEDING 
POINTS:  
 
(1 POINT) Gets food from plate into 
mouth without help. Preparation of food 
may be done by another person. 
(0 POINTS) Needs partial or total help 
with feeding or requires parenteral feeding. 
 

 
Page 
24 of 2 
 
 
Exercise and dialysis, version: 22 
Date: 02/14/2023 
Page 46 of 60 
 
 
 
 
Slightly adapted from Katz, S., Down, T.D., Cash, H.R., & Grotz, R.C. (1970) 
Progress in the development of the index of ADL. 
The Gerontologist, 10(1), 20-30. 
Copyright © The Gerontological Society of America. Reproduced [Adapted] by 
permission of the publisher. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TOTAL POINTS = 
6 = High (patient independent) 0 = Low (patient very dependent) 
 
 
Best Practices in Nursing 
 
A series provided by The Hartford Institute for Geriatric Nursing, 
New York University, College of Nursing 
EMAIL hartford.ign@nyu.edu HARTFORD INSTITUTE WEBSITE www.hartfordign.org 
CLINICAL NURSING WEBSITE www.ConsultGeriRN.org 

 
Page 
24 of 2 
 
 
Exercise and dialysis, version: 22 
Date: 02/14/2023 
Page 47 of 60 
 
 
Short Physical Performance Battery 
 
 
  
 
About: This battery assesses lower extremity function in adults. 
 
Items: 5 
 
Reliability: 
Internal consistency of the SPPB is 0.76 
 
Validity: 
Has predictive validity, showing a gradient of risk for mortality, nursing 
home admission, and disability. 
 
Scoring: 
See scoring information in each section. 
Scores range from 0 (worst performance) to 12 (best performance). 
 
References: 
Guralnik, J. M., Simonsick, E. M., Ferrucci, L., Glynn, R. J., Berkman, L. F., 
Blazer, D. G., Scherr, P. A., Wallace, R. B. (1994) A short physical 
performance battery assessing lower extremity function: Association 
with self-reported disability and prediction of mortality and nursing 
home admission. Journal of Gerontology, 49, M85-M94. 
 

 
Page 
24 of 2 
 
 
Exercise and dialysis, version: 22 
Date: 02/14/2023 
Page 48 of 60 
 
 
1. Repeated Chair Stands 
Instructions: Do you think it is safe for you to try and stand up from a 
chair five times without using your arms? Please stand up straight as 
quickly as you can five times, without stopping in between. After 
standing up each time, sit down and then stand up again. Keep your 
arms folded across your chest. Please watch while I demonstrate. I’ll be 
timing you with a stopwatch. Are you ready? Begin 
 
Grading: Begin stop watch when subject begins to stand up. Count 
aloud each time subject arises. Stop the stopwatch when subject has 
straightened up completely for the fifth time. Also stop if the subject uses 
arms, or after 1 minute, if subject has not completed rises, and if 
concerned about the subject’s safety.. Record the number of seconds 
and the presence of imbalance.. Then complete ordinal scoring. 
 
Time:  
sec (if five stands are completed) 
Number of Stands Completed: 1 2 3 4 5 
 
Chair Stand Ordinal Score:   
 
 
0 = unable 
1 = > 16.7 sec 
2 = 16.6-13.7 sec 
3 = 13.6-11.2 sec 
4 = < 11.1 sec 
 
2. Balance Testing 
Begin with a semitandem stand (heel of one foot placed by the big toe of 
the other foot). Individuals unable to hold this position should try the 
side-by-side position. Those able to stand in the semitandem position 
should be tested in the full tandem position. Once you have completed 
time measures, complete ordinal scoring. 
 
a. Semitandem Stand 
Instructions: Now I want you to try to stand with the side of the heel of 
one foot touching the big toe of the other foot for about 10 seconds. You 
may put either foot in front, whichever is more comfortable for you. 

 
Page 
24 of 2 
 
 
Exercise and dialysis, version: 22 
Date: 02/14/2023 
Page 49 of 60 
 
Please watch while I demonstrate. 

 
 
Exercise and dialysis, version: 22 
Date: 02/14/2023 
Page 50 of 60 
 
Grading: Stand next to the participant to help him or her into 
semitandem position. Allow participant to hold onto your arms to get 
balance. Begin timing when participant has the feet in position and lets 
go. 
 
Circle one number 
2. Held for 10 sec 
1. Held for less than 10 sec; number of seconds held   
 
0. Not attempted 
 
b. Side-by-Side stand 
Instructions: I want you to try to stand with your feet together, side by 
side, for about 10 sec. Please watch while I demonstrate. You may use 
your arms, bend your knees, or move your body to maintain your 
balance, but try not to move your feet. Try to hold this position until I tell 
you to stop. 
 
Grading: Stand next to the participant to help him or her into the side- 
by-side position. Allow participant to hold onto your arms to get balance. 
Begin timing when participant has feet together and lets go. 
 
Grading 
2. Held of 10 sec 
1. Held for less than 10 sec; number of seconds held  
 
0. Not attempted 
 
c. Tandem Stand 
Instructions: Now I want you to try to stand with the heel of one foot in 
front of and touching the toes of the other foot for 10 sec. You may put 
either foot in front, whichever is more comfortable for you. Please watch 
while I demonstrate. 
 
Grading: Stand next to the participant to help him or her into the side- 
by-side position. Allow participant to hold onto your arms to get balance. 
Begin timing when participant has feet together and lets go. 
 
Grading 
2. Held of 10 sec 
1. Held for less than 10 sec; number of seconds held  
 

 
 
Exercise and dialysis, version: 22 
Date: 02/14/2023 
Page 51 of 60 
 
0. Not attempted 

 
 
Exercise and dialysis, version: 22 
Date: 02/14/2023 
Page 52 of 60 
 
 
 
Balance Ordinal Score:   
 
0 = side by side 0-9 sec or unable 
1 = side by side 10, <10 sec semitandem 
2 = semitandem 10 sec, tandem 0-2 sec 
3 = semitandem 10 sec, tandem 3-9 sec 
4 = tandem 10 sec 
 
3. 8’ Walk (2.44 meters) 
Instructions: This is our walking course. If you use a cane or 
other walking aid when walking outside your home, please use it 
for this test. I want you to walk at your usual pace to the other end 
of this course (a distance of 8’). Walk all the way past the other 
end of the tape before you stop. I will walk with you. Are you 
ready? 
 
Grading: Press the start button to start the stopwatch as the 
participant begins walking. Measure the time take to walk 8’. 
Then complete ordinal scoring. 
 
Time:  
sec 
Gait Ordinal 
Score: 
0 = could not do 
1 = >5.7 sec (<0.43 m/sec) 
2 = 4.1-6.5 sec (0.44-0.60 m/sec) 
3 = 3.2-4.0 sec (0.61-0.77 m/sec) 
4 = <3.1 sec (>0.78 m/sec) 
 
Summary Ordinal Score: 
Range: 0 (worst performance) to 12 (best performance). 
 
 
 
 
 

 
 
Exercise and dialysis, version: 22 
Date: 02/14/2023 
Page 53 of 60 
 
 
 
Beck's Depression Inventory 
This depression inventory can be self-scored. The scoring scale is at the end of the 
questionnaire. 1. 
0 
I do not feel sad. 
1 
I feel sad 
2 
I am sad all the time and I can't snap out of it. 
3 
I am so sad and unhappy that I can't stand it. 
2. 
0 
I am not particularly discouraged about the future. 
1 
I feel discouraged about the future. 
2 
I feel I have nothing to look forward to. 
3 
I feel the future is hopeless and that things cannot improve. 
3. 
0 
I do not feel like a failure. 
1 
I feel I have failed more than the average person. 
2 
As I look back on my life, all I can see is a lot of failures. 
3 
I feel I am a complete failure as a person. 
4. 
0 
I get as much satisfaction out of things as I used to. 
1 
I don't enjoy things the way I used to. 
2 
I don't get real satisfaction out of anything anymore. 
3 
I am dissatisfied or bored with everything. 
5. 
0 
I don't feel particularly guilty 
1 
I feel guilty a good part of the time. 
2 
I feel quite guilty most of the time. 
3 
I feel guilty all of the time. 
6. 
0 
I don't feel I am being punished. 
1 
I feel I may be punished. 
2 
I expect to be punished. 
3 
I feel I am being punished. 
7. 
0 
I don't feel disappointed in myself. 

 
 
Exercise and dialysis, version: 22 
Date: 02/14/2023 
Page 54 of 60 
 
 
1 
I am disappointed in myself. 
2 
I am disgusted with myself. 
3 
I hate myself. 
8. 
0 
I don't feel I am any worse than anybody else. 
1 
I am critical of myself for my weaknesses or mistakes. 
2 
I blame myself all the time for my faults. 
3 
I blame myself for everything bad that happens. 
9. 
0 
I don't have any thoughts of killing myself. 
1 
I have thoughts of killing myself, but I would not carry them out. 
2 
I would like to kill myself. 
3 
I would kill myself if I had the chance. 
10. 
0 
I don't cry any more than usual. 
1 
I cry more now than I used to. 
2 
I cry all the time now. 
3 
I used to be able to cry, but now I can't cry even though I want to. 
11. 
0 
I am no more irritated by things than I ever was. 
1 
I am slightly more irritated now than usual. 
2 
I am quite annoyed or irritated a good deal of the time. 
3 
I feel irritated all the time. 
12. 
0 
I have not lost interest in other people. 
1 
I am less interested in other people than I used to be. 
2 
I have lost most of my interest in other people. 
3 
I have lost all of my interest in other people. 
13. 
0 
I make decisions about as well as I ever could. 
1 
I put off making decisions more than I used to. 
2 
I have greater difficulty in making decisions more than I used to. 
3 
I can't make decisions at all anymore. 
14. 
0 
I don't feel that I look any worse than I used to. 
1 
I am worried that I am looking old or unattractive. 

 
 
Exercise and dialysis, version: 22 
Date: 02/14/2023 
Page 55 of 60 
 
 
2 
I feel there are permanent changes in my appearance that make me 
look unattractive 
3 
I believe that I look ugly. 
15. 
0 
I can work about as well as before. 
1 
It takes an extra effort to get started at doing something. 
2 
I have to push myself very hard to do anything. 
3 
I can't do any work at all. 
16. 
0 
I can sleep as well as usual. 
1 
I don't sleep as well as I used to. 
2 
I wake up 1-2 hours earlier than usual and find it hard to get back to sleep. 
3 
I wake up several hours earlier than I used to and cannot get back to sleep. 
 
17. 
0 
I don't get more tired than usual. 
1 
I get tired more easily than I used to. 
2 
I get tired from doing almost anything. 
3 
I am too tired to do anything. 
18. 
0 
My appetite is no worse than usual. 
1 
My appetite is not as good as it used to be. 
2 
My appetite is much worse now. 
3 
I have no appetite at all anymore. 
19. 
0 
I haven't lost much weight, if any, lately. 
1 
I have lost more than five pounds. 
2 
I have lost more than ten pounds. 
3 
I have lost more than fifteen pounds. 
20. 
0 
I am no more worried about my health than usual. 
1 
I am worried about physical problems like aches, pains, upset 
stomach, or constipation. 
2 
I am very worried about physical problems and it's hard to think of much else. 
3 
I am so worried about my physical problems that I cannot think of anything 
else. 

 
 
Exercise and dialysis, version: 22 
Date: 02/14/2023 
Page 56 of 60 
 
 
21. 
0 
I have not noticed any recent change in my interest in sex. 
1 
I am less interested in sex than I used to be. 
2 
I have almost no interest in sex. 
3 
I have lost interest in sex completely. 
 
 
INTERPRETING THE BECK DEPRESSION INVENTORY 
 
Now that you have completed the questionnaire, add up the score for each of the 
twenty-one questions by counting the number to the right of each question you 
marked. The highest possible total for the whole test would be sixty-three. This would 
mean you circled number three on all twenty-one questions. Since the lowest 
possible score for each question is zero, the lowest possible score for the test would 
be zero. This would mean you circles zero on each question. 
You can evaluate your depression according to the 
Table below. Total Score  
Levels of Depression 
1-10  
These ups and downs are considered 
normal 11-16 
Mild mood disturbance 
17-20  
Borderline clinical 
depression 21-30  
Moderate depression 
31-40  
Severe 
depression over 40  
 Extreme 
depression 
 

 
 
Exercise and dialysis, version: 22 
Date: 02/14/2023 
Page 57 of 60 
 
 

 
 
Exercise and dialysis, version: 22 
Date: 02/14/2023 
Page 58 of 60 
 
 
 

 
 
Exercise and dialysis, version: 22 
Date: 02/14/2023 
Page 59 of 60 
 
 

 
 
Exercise and dialysis, version: 22 
Date: 02/14/2023 
Page 60 of 60