Home-Based Exercise as an Intervention to Treat Decreased Physical Function in Patients With Varying Levels of Kidney Function
Phase: NA
Conditions: Chronic Kidney Disease
Sponsor: Baylor College of Medicine

 
 
 
Home-Based Exercise to Treat Decreased Physical Function  
in Patients With Varying Levels of Kidney Function 
 
NCT04745169 
 
2/7/2024 
 
PI: Elizabeth Lorenz, MD, Baylor College of Medicine 
 
 
 
 
 
 

Background Information 
    
Frailty and/or decreased physical function are signiﬁcant risk factors for adverse outcomes in 
kidney transplant candidates, including worsening health-related quality of life, falls, 
hospitalizations and death. Furthermore, frailty is associated with numerous adverse outcomes 
after kidney transplant. For example, pre-transplant frailty is associated with delayed graft 
function, increased length of stay, re-hospitalizations, and mortality following kidney transplant. 
Given the scarcity of donor organs for transplantation, better objective methods of identifying 
kidney transplant candidates who are at high risk of adverse outcomes are needed, and 
modiﬁable risk factors such as frailty should be addressed prior to kidney transplantation. 
Although frailty has been shown to be modiﬁable in non-transplant populations, anti-frailty 
interventions are understudied in kidney transplant patients. We recently demonstrated that 8-
weeks of supervised, center-based exercise is associated with improved frailty parameters and 
SPPB scores in patients with advanced chronic kidney disease, including kidney transplant 
candidates. Speciﬁcally, we conducted a pilot study involving 21 participants who attended 
center-based Pulmonary Rehabilitation (PR) for up to 1 hour twice per week for 8 weeks. Center-
based PR involves a regimen of standardized aerobic conditioning, strength training, and 
ﬂexibility training according to American Thoracic Society guidelines. We found that the 
intervention was safe, feasible, and associated with improved frailty parameters and SPPB 
scores. 
Although center-based rehabilitation programs have proven beneﬁt in terms of morbidity and 
mortality, they are underutilized and limited by lack of participation. A promising alternative to 
center-based programs is home-based programs. In these programs, patients do not need to 
leave their homes to exercise. Center personnel can provide indirect supervision, coaching, 
troubleshooting, and motivational interviewing via phone. One of the most widely available, 
standardized home-based programs currently available in the United States is home-based CR. 
Recent studies have demonstrated that home-based CR can be as beneﬁcial as center-based 
CR and associated with better adherence and participation rates (Thomas RJ et al. Circulation 
2019). The exercise component of CR is very similar to that of PR. Both programs are accredited 
by the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) and 
involve aerobic conditioning, strength training, and ﬂexibility training. Thus, home-based CR 
may be a safe and viable option for patients with chronic kidney disease unable to attend a 
center-based program. The aim of our current study is to determine whether home-based CR 
will improve frailty parameters and SPPB scores in patients with varying levels of kidney 
function. If our hypothesis is supported by the ﬁndings of this study, a home-based exercise 
program could be implemented prior to kidney transplantation with the ultimate goal of 
improving HRQOL and transplant outcomes in kidney transplant candidates. 
  
Purpose and Objectives 

    
The purpose of our current study is to determine whether home-based cardiac rehabilitation is 
an effective intervention that will improve frailty parameters and Short Physical Performance 
Battery scores in patients with varying levels of kidney function. We will also determine if home-
based exercise improves health-related quality of life, physical activity, and adverse outcomes, 
including hospitalizations and death. If our hypothesis is supported by the ﬁndings of this study, 
a home-based exercise program could be implemented prior to kidney transplantation with the 
ultimate goal of improving health-related quality of life and transplant outcomes in kidney 
transplant candidates in the future. 
  
Protocol Risks/Subjects 
Risk Category 
    Category 1: Research not involving greater than minimum risk. 
Subjects 
Gender: 
    Both
Age: 
    Adult (18-64 yrs), Geriatric (65+ yrs) 
Ethnicity: 
    All Ethnicities
Primary Language: 
    English 
Groups to be recruited will include: 
    Patients 
Which if any of the following vulnerable populations will be recruited as subjects? 
    
Vulnerable populations require special protections.  How will you obtain informed consent, 
protect subject conﬁdentiality, and prevent undue coercion? 
    

Pregnant woman/fetus 
Will pregnant women and/or fetuses (as described in 45 CFR 46 Subpart B) be enrolled in the 
research? 
    No 
Neonates 
Will neonates of uncertain viability or nonviable neonates (as described in 45 CFR 46 Subpart B) 
be enrolled in the research? 
    No 
Children 
Will children be enrolled in the research? 
    No 
  
Design/Procedure 
Design 
Select one category that most adequately describes your research: 
    c) Pilot 
Discuss the research design including but not limited to such issues as: probability of group 
assignment, potential for subject to be randomized to placebo group, use of control subjects, etc. 
    
This study is a prospective interventional study, which involves use of existing and prospectively 
collected data. This pilot study will be conducted at Baylor College of Medicine examining the 
feasibility, safety, acceptability, and preliminary efficacy of home-based exercise on frailty 
parameters and Short Physical Performance Battery score in patients with varying levels of 
kidney function. We plan to accrue up to 20 adult patients with chronic kidney disease. The 
effects of exercise on health-related quality of life, physical activity, and adverse outcomes 
including hospitalizations and death, will also be explored. 
Inclusion Criteria: 
    
1. Age 18 years or older 2. Ability to consent to research 3. Chronic kidney disease (stages 1-5) 
4. A Short Physical Performance Battery score ≤10 and/or considered frail or pre-frail according 
to the Fried Frailty Phenotype 

Exclusion Criteria: 
    
1. Younger than 18 years 2. Patients being evaluated for combined organ transplantation 3. 
Signiﬁcant comorbidities that limit rehabilitation potential including pulmonary disease 
requiring continuous oxygen supplementation, active angina, critical aortic sclerosis, 
decompensated heart failure, or known ventricular arrhythmia. 4. An Short Physical 
Performance Battery score >10 or not considered frail or pre-frail by the Fried Frailty Phenotype 
5. Non-English speaker without availability of adequate interpreter services (safety concern) 6. 
Failure to pass submaximal exercise test in patients not approved for kidney transplantation at 
our center 
Procedure 
    
Screening and Recruitment: 
Potential participants will be identiﬁed from dialysis units, nephrology clinics, primary care 
clinics, or kidney transplant clinics at Baylor College of Medicine clinic. If the study team is 
unable to reach the patient after three attempts involving phone calls and/or portal messages, 
an Institutional Review Board-approved contact letter may be sent up to two times. Patients 
who express interest in the study will go through the informed consent process with a member 
of the study team, and patients wishing to participate in the study will complete written 
consent. If patients have not had frailty and Short Physical Performance Battery testing within 
the two weeks prior to consent, the study team member will perform frailty and Short Physical 
Performance Battery testing at baseline in a supervised setting. Patients who are not frail or pre-
frail and have a Short Physical Performance Battery score > 10 will be ineligible for study 
participation. Patients with stage 1-5 chronic kidney disease who are not currently approved for 
kidney transplant at our center will undergo a submaximal exercise test to rule out any 
signiﬁcant, undiagnosed cardiopulmonary disease if they meet one or more of the following 
criteria: 1) diabetes, 2) age > 59, 3) prior coronary artery disease deﬁned as history of 
myocardial infarction, coronary artery stenting, or coronary artery bypass grafting, or 4) current 
smoking. During the initial study visit, consenting patients will be provided with a pedal 
exerciser, resistance bands, and exercise pamphlets (Mayo Clinic Patient Education Pulmonary 
Rehabilitation: Exercise Program, Exercise Program Guidelines, Exercises for the Legs). 
Participants will be given the option of having the pedal exerciser mailed to their home. 
Exercise Intervention: 
Participants will be asked to complete an 8-week home-based exercise program with a focus on 
the core components of physical activity counseling and exercise training according to 
guidelines from the American Heart Association and the American Association of 
Cardiovascular and Pulmonary Rehabilitation (Balady GJ Circulation 2007). During the program, 
participants will receive weekly semi-scripted phone calls from an exercise physiologist from 
the Mayo Clinic Cardiac Rehabilitation program. During the baseline phone call, the exercise 
physiologist will assess the patients current level of physical activity; discuss warm-up, cool-

down, and ﬂexibility exercises; review the Borg Rating of Perceived Exertion (RPE); set goals with 
the patient; and answer any questions they might have. The exercise physiologist will then 
document in the electronic medical record any warning symptoms the participant experienced 
during physical activity or exercise; recent hospitalizations, important medical appointments, 
urgent care, or emergency department visits; goals set during phone call; an individualized 
exercise prescription. Study personnel will then send the individualized exercise prescription to 
the participant via mail, portal, or email. Recommended aerobic exercises will include arm 
and/or leg ergometry using a pedal exerciser. Recommended resistance training will include 
resistance bands. Patients will be encouraged to obtain at least 30 minutes of moderate-
intensity physical activity at least ﬁve days per week. Gradual increases in the volume of 
physical activity will be recommended over time. Participants on dialysis will be advised not to 
exercise after in-center hemodialysis on dialysis days (if applicable). Participants will be asked 
to log information regarding their exercise sessions on paper, including type, duration, and Borg 
RPE scale. 
During the subsequent weekly phone calls, the exercise physiologist will inquire about any 
interim symptoms or events, answer any questions regarding the exercise program, review goals 
set during the previous phone call and what the patient has done to work toward those goals, 
and set new goals if applicable. During each weekly phone call, the exercise physiologist will 
review and record information from the patients exercise log and enter it into the patients 
electronic medical record. Information entered by exercise physiologists into the electronic 
medical record will also be entered into REDCap by study personnel. 
Participants will be instructed to stop exercising and sit down and rest if they develop any of the 
following signs: chest tightness, pressure, or pain; severe shortness of breath; light-headedness 
or dizziness; stomach pain; upset stomach, throwing up or a headache; pulse rate that is not 
normal for them; extreme fatigue; profuse sweating. They will be advised to seek emergency 
care (call 911) immediately for chest tightness, pressure, or pain in the chest or severe 
shortness of breath that does not go away within 3 to 5 minutes. Home-based exercise will be 
stopped if the study team feels it is no longer safe for the participant to continue exercise. If a 
participant experiences any of the above symptoms during or after exercising, the principal 
investigators will be notiﬁed. If the principal investigators determine it is no longer safe for the 
participant to continue the exercise program following discomfort, injury, or a medical 
emergency during an exercise session, the participant will be withdrawn from the study. 
Reasons for participant withdrawal will be recorded. 
Study measures: 
Participants will complete the following Short Physical Performance Battery testing and other 
study measures at baseline and after completion of the exercise program: 
1. Fried Frailty Phenotype: The Fried Frailty Phenotype consists of a gait speed test, a grip 
strength test, and self-reported measures of physical activity, weight loss, and exhaustion. a. 
Gait speed test: The time required for the participant to walk a distance of 15 feet at a self-

selected walking speed will be measured using a stopwatch. To determine whether the 
participant is frail by the Fried Frailty Phenotype, the average of 2 trials will be calculated and 
adjusted for sex and height. b. Hand grip strength test: Hand grip strength will be measured 
using a Jamar Digital Hand Held Dynamometer. Participants will complete the grip strength test 
3 times with their dominant hand (or the arm without their dialysis ﬁstula or graft). The 3 trials 
will be averaged and adjusted by sex and body mass index using a normative table. c. Minnesota 
Leisure-time Physical Activity Questionnaire: Participants will answer questions from this 
questionnaire regarding how often they engage in different activities. d. Self-reported weight 
loss: Patients will be asked whether they unintentionally lost 10 or more pounds within the last 
year. e. Center for Epidemiologic Studies Depression Scale (CES-D): Participants will answer 2 
questions from the CES-D about their level of exhaustion. 2. Short physical performance battery 
(SPPB): The Short Physical Performance Battery consists of a gait speed test over 4 meters (13.1 
feet), timed repeated chair stands, and three balance tests. a. Gait speed test: The participants 
gait speed velocity over 4 meters will be calculated by converting the results of the participants 
gait speed test (please see Fried Frailty phenotype above) to meters per second. b. Timed 
repeated chair stands: Participants will be asked if they feel safe to stand from a chair without 
the use of their arms and without assistance. If the participant feels safe to stand from a chair 
without the use of their arms and without assistance, they will be asked to complete 5 repeated 
chair stands. The participants SPPB score will be determined by the time required to complete 5 
repeated chair stands. c. Balance testing: The participants balance will be tested in side-by-
side, semi-tandem, and tandem stands. In the side-by-side stand, participants will stand with 
their feet as close together as possible. In the semi-tandem stands, participants will stand with 
one heel touching the big toe of the opposite foot. In the tandem stands, participants will stand 
with the heel of one foot in front of the toes of the other foot (as if on a balance beam). 
Participants will be asked to hold each position for up to 10 seconds. 
3. Kidney Disease Quality of Life Short Form (KDQOL-SF), Version 1.3: Participants will 
complete this 37-item questionnaire, which consists of questions regarding the patients kidney 
disease, their quality of life, and demographic characteristics. 4. Actigraph: Participants will be 
asked to wear an actigraph on their upper extremity for 7 days in a row and mail the device back 
to us in a prepaid envelope. The actigraph monitoring will be performed both at baseline and 
after completion of the exercise intervention. 5. Weight: Participants' weight will be measured 
on a scale. 
Demographic and health information: At baseline, participants will be asked to self-report their 
marital status, employment status, insurance, education, income, smoking history, time on 
dialysis, dialysis type and location, and dialysis days. If patients do not provide this information, 
it will be collected from the medical record when possible. Medical information, including body 
mass index, cause of renal disease, previous kidney transplant, and comorbidities, will be 
abstracted from the participants’ medical record. 
Participants will be offered the option of completing questionnaires via Baylor College of 
Medicine iPAD, on paper, or over the phone. Participants will be able to skip any question that 
makes them uncomfortable or that they do not want to answer. 

If a participant feels unsafe or if the study team member performing the frailty/Short Physical 
Performance Battery tests feels the participant is unsafe at any point during the frailty/Short 
Physical Performance Battery tests, the participant will not be asked to complete that measure. 
End of Intervention Qualitative Survey: 
Following completion of the home-based exercise program, participants will be asked to 
complete a qualitative/satisfaction survey. Approximately one month after completion of the 
exercise program, participants will be asked to complete some additional questions via phone 
or mail to ascertain if they are still exercising. 
A Data Transfer Agreement will be obtained between Mayo Clinic and Baylor College of 
Medicine so that a limited data set involving subjects from Mayo Clinic can be accessed from 
Baylor College of Medicine. Mayo Clinic will share the data with Baylor using encrypted email 
and/or Microsoft Simple Share. The limited dataset that will be shared will include 
demographics, dates of participation in the exercise intervention, information about the 
exercise intervention (i.e. duration of study phone calls, participant exercise log), study 
outcome data (including data from frailty assessments, body composition assessments, 
accelerometers, and questionnaires), and medical/laboratory information abstracted from the 
medical record. 
  
Sample Size/Data Analysis 
Sample Size 
How many subjects (or specimens, or charts) will be used in this study? 
    Local: 20              Worldwide: 20
Please indicate why you chose the sample size proposed: 
    
This is a pilot study so it doesn't require sample size calculations. However, we chose our 
recruitment target based on a prior study examining the impact of exercise on frailty parameters 
which was able to show signiﬁcant differences with a similar number of study participants. 
Data Analysis 
Provide a description of your plan for data analysis. State the types of comparisons you plan (e.g. 
comparison of means, comparison of proportions, regressions, analysis of variance). Which is the 
PRIMARY comparison/analysis? How will the analyses proposed relate to the primary purposes of 
your study? 

    
Categorical variables will be summarized as counts and percentages with continuous variables 
summarized via medians and interquartile ranges. Pre- and post- comparisons will be made 
using paired, one-sample Wilcoxon signed rank tests for continuous variables and chi-square 
tests for categorical variables. Differences between groups will be assessed using two-sample 
Wilcoxon tests for continuous variables and Fisher's exact tests for categorical variables. P-
values less than 0.05 will be considered statistically signiﬁcant. We will make no adjustments in 
the p-value for multiple hypothesis testing. 
  
Potential Risks/Discomforts 
Describe and assess any potential risks/discomforts; (physical, psychological, social, legal, or 
other) and assess the likelihood and seriousness of such risks: 
    
We expect the occurrence of adverse events to be rare. All AEs will be reported immediately to 
the principal investigators and properly documented. Serious Adverse Events (SAEs), 
Unanticipated Problems Involving Risks to Subjects or Others (UPIRTSOs), and any major 
protocol violations will be reported to the IRB within 5 working days of the event. AEs and any 
minor protocol violations will be reported at the time of the continuing review. An explanation of 
the event and how the event was handled will be submitted with each report. The number of 
complaints and the number of study participants who withdrew from the study will be reported 
at each continuing review along with explanations for each complaint and for each withdrawal. 
There is a minimal risk of injury or discomfort during the exercise sessions, and participants 
may be unwilling to answer certain questions within the questionnaires. The potential risks of 
the study are estimated to be equivalent to daily activities. 
  
Potential Beneﬁts 
Describe potential beneﬁt(s) to be gained by the individual subject as a result of participating in 
the planned work. 
    There are no immediate beneﬁts to the participants from this study. The potential beneﬁts of 
this study include improved physical function for the participant. 
Describe potential beneﬁt(s) to society of the planned work. 
    
The investigators hope is to identify whether our hypothesis of a home-based exercise program 
will be feasible, safe, acceptable to patients, and improve frailty parameters and Short Physical 
Performance Battery scores in patients with varying levels of kidney functions. And if the 
ﬁndings of the study support hypothesis, a home-based exercise program could be 

implemented prior to kidney transplantation with the ultimate goal of improving health-related 
quality of life and transplant outcomes in kidney transplant candidates in future. 
Do anticipated beneﬁts outweigh potential risks? Discuss the risk-to-beneﬁt ratio. 
    The expected beneﬁts of developing a feasible and effective exercise intervention in patients 
with decreased physical function outweigh the possible risks. 
  
Consent Procedures 
 Waiver of Consent 
Will any portion of this research require a waiver of consent and authorization? 
    NA
  
Waiver of requirement for written documentation of Consent 
Will this research require a waiver of the requirement for written documentation of informed 
consent? 
    NA
Consent Procedures 
Who will recruit subjects for this study? 
    PI 
PI's staff 
Describe how research population will be identiﬁed, recruitment procedures, any waiting period 
between informing the prospective participant and obtaining consent, steps taken to minimize the 
possibility of coercion or undue inﬂuence and consent procedures in detail. 
    
Potential participants will be identiﬁed from dialysis units, nephrology clinics, primary care 
clinics, or kidney transplant clinics at Baylor College of Medicine. If the study team is unable to 
reach the patient after three attempts involving phone calls and/or portal messages, an 
Institutional Review Board-approved contact letter may be sent up to two times. Patients who 
express interest in the study will go through the informed consent process with a member of the 
study team, and patients wishing to participate in the study will complete written consent. If 
patients have not had frailty and Short Physical Performance Battery testing within the two 
weeks prior to consent, the study team member will perform frailty and Short Physical 

Performance Battery testing at baseline in a supervised setting. Patients who are not frail or pre-
frail and have a Short Physical Performance Battery score > 10 will be ineligible for study 
participation. Patients with stage 1-5 chronic kidney disease who are not currently approved for 
kidney transplant at our center will undergo a submaximal exercise test to rule out any 
signiﬁcant, undiagnosed cardiopulmonary disease if they meet one or more of the following 
criteria: 1) diabetes, 2) age > 59, 3) prior coronary artery disease deﬁned as history of 
myocardial infarction, coronary artery stenting, or coronary artery bypass grafting, or 4) current 
smoking. During the initial study visit, consenting patients will be provided with a pedal 
exerciser, resistance bands, and exercise pamphlets (Mayo Clinic Patient Education Pulmonary 
Rehabilitation: Exercise Program, Exercise Program Guidelines, Exercises for the Legs). 
Participants will be given the option of having the pedal exerciser mailed to their home. 
Are foreign language consent forms required for this protocol? 
    No 
Privacy and Intrusiveness 
Will the research involve observation or intrusion in situations where the subjects would normally 
have an expectation of privacy? 
    No 
Children 
Will children be enrolled in the research? 
    No 
Neonates 
Will non-viable neonates or neonates of uncertain viability be involved in research? 
    No 
Consent Capacity - Adults who lack capacity 
Will Adult subjects who lack the capacity to give informed consent be enrolled in the research? 
    No 
Prisoners 
Will Prisoners be enrolled in the research? 
    No