Chronic Kidney Disease 5DKINETICNCT07446296
Kidney Transplant Improvement Through New Exercise Training to Increase Capacity
A study testing Exercise Rehabilitation Program with Physical Activity Tracker in people with Chronic Kidney Disease 5D and Chronic Kidney Disease Stage 5, run by University of Pennsylvania at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if a home-based exercise program can be safely and feasibly used to improve physical activity and physical function in adults waiting for a kidney transplant. The study will also learn how acceptable and useful this program is for participants. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Chronic Kidney Disease 5D, Chronic Kidney Disease Stage 5, Kidney Failure
- What is being tested?
- Exercise Rehabilitation Program with Physical Activity Tracker
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2026to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be at least 60 years old
- receive transplant care at Penn Medicine
- be on the kidney transplant waiting list
- speak and comprehend English
- be able to walk
- have at least one physical function limitation OR at least one frailty metric
Show all 9Show fewer
- have access to a device capable of connecting to the Internet and downloading an application
- be able to provide written informed consent
- be cleared for participant via the Physical Activity Readiness Questionnaire (PARQ) verified against medical record or via written medical clearance from a clinician
Who cannot join
- Have had a myocardial infarction or a stroke in the 3 months immediately prior to enrollment
- Be unable to self-monitor with study devices (i.e., have a condition such as dementia)
- Not cleared by PARQ or receive written medical clearance to exercise
- Participate in another physical activity study
- Have any other reason they do not expect to be able to complete the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
Sarah Schrauben, MD, MS, 267-324-7588, sarahsch@upenn.edu
About this study
Official title: KINETIC -- Kidney Transplant Improvement Through New Exercise Training to Increase Capacity
The goal of this clinical trial is to learn if a home-based exercise program can be safely and feasibly used to improve physical activity and physical function in adults waiting for a kidney transplant. The study will also learn how acceptable and useful this program is for participants.
The main questions it aims to answer are:
Read more
- Can a remote exercise program be delivered successfully to people on the kidney transplant waiting list?
- Do participants follow the exercise program and wear a physical activity tracker as asked?
- Is the program safe and well tolerated?
Researchers will compare two groups to see if the exercise program leads to higher physical activity and better physical function:
- Usual pre-transplant care with a physical activity tracker
- Usual pre-transplant care plus an online exercise program
Participants will:
- Wear a wrist activity tracker to measure daily physical activity
- Complete a one-week baseline period before being assigned to a study group
- Be randomly assigned (like flipping a coin) to one of two groups
- If assigned to the exercise group, take part in online exercise classes at home for 12 weeks with reminders and feedback, and then another 12 weeks without reminders and feedback
- Answer questionnaires about their health, activity, and experience in the study
This study may help researchers learn how to better support people waiting for kidney transplant through safe, home-based exercise programs.
Read the detailed description
Adults with advanced chronic kidney disease (CKD) awaiting kidney transplantation often experience low physical activity, reduced physical function, and frailty. Poor physical function before transplant is associated with longer hospital stays, higher complication rates, delayed recovery, and worse post-transplant outcomes. Despite these risks, there are few scalable, evidence-based prehabilitation programs designed specifically for kidney transplant candidates.
KINETIC (Kidney Transplant Improvement through New Exercise Training to Increase Capacity) is a randomized clinical trial designed to evaluate the feasibility, acceptability, and preliminary effectiveness of a home-based, technology-enabled exercise prehabilitation program for adults on the kidney transplant waiting list.
Study Objectives The primary objective of this study is to evaluate the feasibility of delivering a 12-week, remote exercise prehabilitation program to kidney transplant candidates using an online exercise platform and wearable activity tracker.
Secondary objectives include evaluating:
Participant adherence to the exercise intervention Safety and tolerability of light-to-moderate intensity exercise in this population Changes in physical activity and physical function Participant-reported usability, satisfaction, and implementation outcomes Exploratory clinical outcomes relevant to transplant readiness and health status
Study Design
KINETIC is a randomized, parallel-group clinical trial. Participants will be randomized in a 1:1 ratio to either:
- Usual Care with a wearable activity tracker, or
- Exercise Prehabilitation Intervention with a wearable activity tracker and access to a structured online exercise program.
All participants will complete a one-week baseline run-in period during which physical activity data are collected to establish baseline step counts prior to randomization.
Study Population Eligible participants are adults (≥60 years old) who are actively listed for kidney transplantation and are able to ambulate independently. Participants must have access to a smartphone, tablet, or computer with internet access and be medically stable enough to engage in light-to-moderate intensity physical activity.
To ensure participant safety, all individuals will complete the Physical Activity Readiness Questionnaire (PAR-Q) prior to enrollment. If the PAR-Q identifies potential cardiovascular, pulmonary, or metabolic risk, written medical clearance will be obtained.
Randomization After completion of the run-in period, participants will be randomized using a secure electronic system. Randomization will be stratified by baseline physical activity level (low vs higher activity) to promote balance between study arms.
Wearable Activity Monitoring All participants will receive a wrist-worn activity tracker to objectively measure daily physical activity, including step counts and activity duration.
Data Collection and Outcomes
Data collected during the study include:
- Objective physical activity metrics from wearable devices
- Physical function assessments
- Participant-reported outcomes
- Adherence to exercise sessions (intervention arm)
- Safety events, hospitalizations, and adverse symptoms
Feasibility outcomes include recruitment rates, retention, adherence to the intervention, and completeness of data collection. Safety outcomes include adverse events related to physical activity and study participation.
.
- Conditions
- Chronic Kidney Disease 5D, Chronic Kidney Disease Stage 5, Kidney Failure, Kidney Failure,Chronic, Renal Insufficiency Chronic, Chronic Kidney Disease Stage 4
- Being tested
- Exercise Rehabilitation Program with Physical Activity Tracker, Active control
- Keywords
- kidney transplant candidates, prehabilitation, home-based exercise, physical activity program, kidney transplant waiting list, pre-transplant care, physical function
- Medical subject headings
- Renal Insufficiency, Chronic, Renal Insufficiency, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Rehabilitation Program with Physical Activity TrackerBehavioural
Also called walking, home-based exercise
Participants in this arm will continue to receive their usual pre-transplant care and will also take part in a 12-week, home-based exercise prehabilitation program. Participants will receive a wrist-worn physical activity tracker and access to an online exercise platform designed for people with kidney disease. The program includes live and on-demand exercise classes that focus on light-to-moderate intensity aerobic and resistance exercises. Participants will be asked to complete at least two exercise classes per week. The intervention is delivered remotely, and participants will complete a brief virtual orientation before starting the program. The participants will receive reminders and feedback from the study team about their exercise and physical activity engagement. After the 12 week period, this group will be asked to continue to participate in the exercise program but without study reminders or feedback related to their exercise.
Active controlOther
Participants continue standard pre-transplant care provided by the transplant center and to wear a wrist worn activity tracker to measure daily step counts/physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care with Physical Activity Tracker | Other | Participants in this arm will continue to receive their usual pre-transplant care provided by the transplant center. In addition, participants will receive a wrist-worn physical activity tracker to measure daily activity, including step counts. Participants will be asked to wear the activity tracker throughout the study period, but they will not receive structured exercise programming or exercise-related coaching as part of the study. Receives: Other: Active control |
| Exercise Prehabilitation Program with Physical Activity Tracker | Experimental | Participants in this arm will continue to receive their usual pre-transplant care and will also take part in a 12-week, home-based exercise prehabilitation program. Participants will receive a wrist-worn physical activity tracker and access to an online exercise platform designed for people with kidney disease. The program includes live and on-demand exercise classes that focus on light-to-moderate intensity aerobic and resistance exercises. Participants will be asked to complete at least two exercise classes per week. The intervention is delivered remotely, and participants will complete a brief virtual orientation before starting the program. Receives: Behavioral: Exercise Rehabilitation Program with Physical Activity Tracker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment efficiency and Retention
Feasibility will be assessed by enrollment efficiency and participant retention. Enrollment efficiency will be calculated as the percentage of participants successfully enrolled after invitation. Thresholds of success include, ≥70% of potentially eligible agree to screening and ≥40% of eligible consent and enroll Retention will be measured as the percentage of enrollment participants who complete the 12-week study period. The threshold of successful retention is ≥70%.
Measured: Enrollment efficiency time period is study duration (anticipate up to 20 moths) and retention is 12 weeks of intervention period
Acceptability of the Intervention
Acceptability will be measured using the System Usability Scale (SUS), a validated questionnaire assessing usability and satisfaction with the study system. SUS scores will be calculated using standard scoring methods. Scores of 68 or higher will be considered indicative of acceptable usability. Quantitative findings will be supplemented with qualitative feedback from participants, including themes related to acceptability identified through end-of-study exit interviews.
Measured: 12-weeks after randomization
Adherence
Adherence will be assessed as the percentage of study days with valid step count data and, for participants in the intervention arm, the percentage of completed exercise sessions out of those recommended during the 12-week intervention period. Feasible adherence will be defined as ≥70% of study days with valid step count data and ≥70% of participants in the intervention arm completed ≥2 exercise classes per week.
Measured: 12 weeks after randomization
Adverse Events Related to Intervention
Safety will be evaluated by documenting the number and type of adverse events occurring during the study period.
Measured: Up to 12 weeks after randomization
Secondary outcomes (14)
Change in Short Physical Performance Battery (SPPB) Score
Change in Short Physical Performance Battery (SPPB) total score will be compared between study groups.
The SPPB total score is calculated by summing the scores from three performance-based components:
Standing balance test 4-meter gait speed test Five-times sit-to-stand test Each component is scored from 0 to 4, and the three component scores are summed to produce a total score ranging from 0 to 12, with higher scores indicating better physical function.
The aggregated total score (0-12 points) will be used as the outcome measure.
Measured: 13 and 25 weeks relative to baseline
Change in Daily Physical Activity (Step Counts)
Daily physical activity will be assessed using wearable activity trackers. Between-group differences in average daily step counts will be evaluated after intervention period of 12 weeks.
Measured: 12 weeks of intervention period
Changes in Health Related Quality of Life
Changes in SF-36 compared between study groups- 36-item measure evaluating functional status and perceptions of health status, scored from 0 to 100; higher scores associated with greater perceived HRQOL. between study groups.
Measured: 13 and 25 weeks relative to baseline
Change in Frailty Status
Physical function will be assessed using Between-group differences in Frailty status using the Fried Frailty Phenotype
Measured: 13 and 25 weeks relative to baseline
Change in Gait Speed
Physical function will be assessed using between-group differences in Gait speed (meters/second)
Measured: 13 and 25 weeks relative to baseline
Change in Chair Stand Time
Physical function will be assessed using Between-group differences in time of Five-times sit-to-stand test (seconds)
Measured: 13 and 25 weeks relative to baseline
Change in Handgrip Strength
Physical function will be assessed using Between-group differences of Handgrip strength (kilograms)
Measured: 13 and 25 weeks relative to baseline
Change in Self-Reported Physical Function
Between-group differences will be evaluated for patient-reported physical functioning using the PF-10 from the SF-36 (score range 0-100, higher scores indicate better physical functioning) and the SF-36 Physical Component Summary score (norm-based score, mean 50, higher scores indicate better physical functioning).
Measured: 13 and 25 weeks after baseline
Changes in Digital Health Literacy
Changes in digital health literacy will be compared between study groups using the Electronic Health Literacy Scale (eHEALS), an 8-item questionnaire assessing perceived ability to find, understand, and use electronic health information. Items use 5-point Likert response options. Total scores range from 8 to 40, with higher scores indicating better digital health literacy
Measured: 13 and 25 weeks relative to baseline
Changes in Health Related Quality of Life
Changes in health-related quality of life will be compared between study groups using the SF-36, a 36-item measure evaluating functional status and perceptions of health. Scores range from 0 to 100, with higher scores indicating better perceived health-related quality of life.
Measured: 13 and 25 weeks relative to baseline
Changes in Self-Efficacy
Changes in self-efficacy will be compared between study groups using the PROMIS Self-Efficacy short form, a 4-item questionnaire assessing confidence in managing health and daily activities. Items use 5-point Likert response options. Higher scores indicate greater self-efficacy.
Measured: 25 and 13 weeks relative to baseline
Changes in Motivation for Physical Activity
Changes in motivation for physical activity will be compared between study groups using the Behavioral Regulation in Exercise Questionnaire (BREQ-3), a 24-item measure assessing different types of exercise motivation. Items use 5-point Likert response options, and scores are calculated as mean subscale scores, with higher scores indicating greater endorsement of that motivational regulation type.
Measured: 25 and 13 weeks relative to baseline
Changes in Social Support
Changes in perceived social support will be compared between study groups using a 6-item questionnaire adapted for physical activity contexts. Items use 5-point Likert response options. Total scores range from 6 to 30, with higher scores indicating greater perceived social support.
Measured: 25 and 13 weeks relative to baseline
Changes in Self-reported Physical Activity
Changes in self-reported physical activity will be compared between study groups using the Rapid Assessment of Physical Activity (RAPA), a 9-item questionnaire assessing participation in aerobic activity, strength training, and flexibility exercises. Any number less than 6 is considered suboptimal.
Measured: 25 and 13 weeks relative to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start24 Mar 2026
- Primary completionMar 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease 5DStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Schrauben, MD, MSCE, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446296
- Sponsor's protocol ID
- 859280
- Other IDs
- R01DK144325
- Acronym
- KINETIC
- Status last verified
- May 2026
- First submitted
- 28 Jan 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study is a feasibility and pilot trial designed to assess acceptability, adherence, and implementation of a remote exercise intervention and to inform the design of a future larger clinical trial. The sample size is small, and the data include detailed behavioral, wearable device, and qualitative information that may increase the risk of participant re-identification. Summary-level results will be reported through publications and ClinicalTrials.gov. Plans for IPD sharing will be reconsidered for future adequately powered trials.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KINETIC -- Kidney Transplant Improvement Through New Exercise Training to Increase Capacity
- ClinicalTrials.gov ID
- NCT07446296
- Acronym / sponsor ID
- KINETIC / 859280
- Conditions
- Chronic Kidney Disease 5D, Chronic Kidney Disease Stage 5, Kidney Failure, Kidney Failure,Chronic, Renal Insufficiency Chronic, Chronic Kidney Disease Stage 4
- Keywords
- kidney transplant candidates, prehabilitation, home-based exercise, physical activity program, kidney transplant waiting list, pre-transplant care, physical function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 24 Mar 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if a home-based exercise program can be safely and feasibly used to improve physical activity and physical function in adults waiting for a kidney transplant. The study will also learn how acceptable and useful this program is for participants.
The main questions it aims to answer are:
- Can a remote exercise program be delivered successfully to people on the kidney transplant waiting list?
- Do participants follow the exercise program and wear a physical activity tracker as asked?
- Is the program safe and well tolerated?
Researchers will compare two groups to see if the exercise program leads to higher physical activity and better physical function:
- Usual pre-transplant care with a physical activity tracker
- Usual pre-transplant care plus an online exercise program
Participants will:
- Wear a wrist activity tracker to measure daily physical activity
- Complete a one-week baseline period before being assigned to a study group
- Be randomly assigned (like flipping a coin) to one of two groups
- If assigned to the exercise group, take part in online exercise classes at home for 12 weeks with reminders and feedback, and then another 12 weeks without reminders and feedback
- Answer questionnaires about their health, activity, and experience in the study
This study may help researchers learn how to better support people waiting for kidney transplant through safe, home-based exercise programs.
Detailed description
Adults with advanced chronic kidney disease (CKD) awaiting kidney transplantation often experience low physical activity, reduced physical function, and frailty. Poor physical function before transplant is associated with longer hospital stays, higher complication rates, delayed recovery, and worse post-transplant outcomes. Despite these risks, there are few scalable, evidence-based prehabilitation programs designed specifically for kidney transplant candidates.
KINETIC (Kidney Transplant Improvement through New Exercise Training to Increase Capacity) is a randomized clinical trial designed to evaluate the feasibility, acceptability, and preliminary effectiveness of a home-based, technology-enabled exercise prehabilitation program for adults on the kidney transplant waiting list.
Study Objectives The primary objective of this study is to evaluate the feasibility of delivering a 12-week, remote exercise prehabilitation program to kidney transplant candidates using an online exercise platform and wearable activity tracker.
Secondary objectives include evaluating:
Participant adherence to the exercise intervention Safety and tolerability of light-to-moderate intensity exercise in this population Changes in physical activity and physical function Participant-reported usability, satisfaction, and implementation outcomes Exploratory clinical outcomes relevant to transplant readiness and health status
Study Design
KINETIC is a randomized, parallel-group clinical trial. Participants will be randomized in a 1:1 ratio to either:
- Usual Care with a wearable activity tracker, or
- Exercise Prehabilitation Intervention with a wearable activity tracker and access to a structured online exercise program.
All participants will complete a one-week baseline run-in period during which physical activity data are collected to establish baseline step counts prior to randomization.
Study Population Eligible participants are adults (≥60 years old) who are actively listed for kidney transplantation and are able to ambulate independently. Participants must have access to a smartphone, tablet, or computer with internet access and be medically stable enough to engage in light-to-moderate intensity physical activity.
To ensure participant safety, all individuals will complete the Physical Activity Readiness Questionnaire (PAR-Q) prior to enrollment. If the PAR-Q identifies potential cardiovascular, pulmonary, or metabolic risk, written medical clearance will be obtained.
Randomization After completion of the run-in period, participants will be randomized using a secure electronic system. Randomization will be stratified by baseline physical activity level (low vs higher activity) to promote balance between study arms.
Wearable Activity Monitoring All participants will receive a wrist-worn activity tracker to objectively measure daily physical activity, including step counts and activity duration.
Data Collection and Outcomes
Data collected during the study include:
- Objective physical activity metrics from wearable devices
- Physical function assessments
- Participant-reported outcomes
- Adherence to exercise sessions (intervention arm)
- Safety events, hospitalizations, and adverse symptoms
Feasibility outcomes include recruitment rates, retention, adherence to the intervention, and completeness of data collection. Safety outcomes include adverse events related to physical activity and study participation.
.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care with Physical Activity Tracker | Other | Other: Active controlParticipants in this arm will continue to receive their usual pre-transplant care provided by the transplant center. In addition, participants will receive a wrist-worn physical activity tracker to measure daily activity, including step counts. Participants will be asked to wear the activity tracker throughout the study period, but they will not receive structured exercise programming or exercise-related coaching as part of the study. |
| Exercise Prehabilitation Program with Physical Activity Tracker | Experimental | Behavioral: Exercise Rehabilitation Program with Physical Activity TrackerParticipants in this arm will continue to receive their usual pre-transplant care and will also take part in a 12-week, home-based exercise prehabilitation program. Participants will receive a wrist-worn physical activity tracker and access to an online exercise platform designed for people with kidney disease. The program includes live and on-demand exercise classes that focus on light-to-moderate intensity aerobic and resistance exercises. Participants will be asked to complete at least two exercise classes per week. The intervention is delivered remotely, and participants will complete a brief virtual orientation before starting the program. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- be at least 60 years old
- receive transplant care at Penn Medicine
- be on the kidney transplant waiting list
- speak and comprehend English
- be able to walk
Key exclusion criteria (5 listed)
- Have had a myocardial infarction or a stroke in the 3 months immediately prior to enrollment
- Be unable to self-monitor with study devices (i.e., have a condition such as dementia)
- Not cleared by PARQ or receive written medical clearance to exercise
- Participate in another physical activity study
- Have any other reason they do not expect to be able to complete the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise Rehabilitation Program with Physical Activity TrackerAlso: walking, home-based exerciseParticipants in this arm will continue to receive their usual pre-transplant care and will also take part in a 12-week, home-based exercise prehabilitation program. Participants will receive a wrist-worn physical activity tracker and access to an online exercise platform designed for people with kidney disease. The program includes live and on-demand exercise classes that focus on light-to-moderate intensity aerobic and resistance exercises. Participants will be asked to complete at least two exercise classes per week. The intervention is delivered remotely, and participants will complete a brief virtual orientation before starting the program. The participants will receive reminders and feedback from the study team about their exercise and physical activity engagement. After the 12 week period, this group will be asked to continue to participate in the exercise program but without study reminders or feedback related to their exercise. | Behavioural | Exercise Prehabilitation Program with Physical Activity Tracker |
| Active controlParticipants continue standard pre-transplant care provided by the transplant center and to wear a wrist worn activity tracker to measure daily step counts/physical activity. | Other | Usual Care with Physical Activity Tracker |
Primary outcome
Enrollment efficiency and Retention
Time frame: Enrollment efficiency time period is study duration (anticipate up to 20 moths) and retention is 12 weeks of intervention period
Feasibility will be assessed by enrollment efficiency and participant retention. Enrollment efficiency will be calculated as the percentage of participants successfully enrolled after invitation. Thresholds of success include, ≥70% of potentially eligible agree to screening and ≥40% of eligible consent and enroll Retention will be measured as the percentage of enrollment participants who complete the 12-week study period. The threshold of successful retention is ≥70%.
Acceptability of the Intervention
Time frame: 12-weeks after randomization
Acceptability will be measured using the System Usability Scale (SUS), a validated questionnaire assessing usability and satisfaction with the study system. SUS scores will be calculated using standard scoring methods. Scores of 68 or higher will be considered indicative of acceptable usability. Quantitative findings will be supplemented with qualitative feedback from participants, including themes related to acceptability identified through end-of-study exit interviews.
Adherence
Time frame: 12 weeks after randomization
Adherence will be assessed as the percentage of study days with valid step count data and, for participants in the intervention arm, the percentage of completed exercise sessions out of those recommended during the 12-week intervention period. Feasible adherence will be defined as ≥70% of study days with valid step count data and ≥70% of participants in the intervention arm completed ≥2 exercise classes per week.
Adverse Events Related to Intervention
Time frame: Up to 12 weeks after randomization
Safety will be evaluated by documenting the number and type of adverse events occurring during the study period.
14 secondary outcomes
Change in Short Physical Performance Battery (SPPB) Score
Time frame: 13 and 25 weeks relative to baseline
Change in Daily Physical Activity (Step Counts)
Time frame: 12 weeks of intervention period
Changes in Health Related Quality of Life
Time frame: 13 and 25 weeks relative to baseline
Change in Frailty Status
Time frame: 13 and 25 weeks relative to baseline
Change in Gait Speed
Time frame: 13 and 25 weeks relative to baseline
Change in Chair Stand Time
Time frame: 13 and 25 weeks relative to baseline
Change in Handgrip Strength
Time frame: 13 and 25 weeks relative to baseline
Change in Self-Reported Physical Function
Time frame: 13 and 25 weeks after baseline
Changes in Digital Health Literacy
Time frame: 13 and 25 weeks relative to baseline
Changes in Health Related Quality of Life
Time frame: 13 and 25 weeks relative to baseline
Changes in Self-Efficacy
Time frame: 25 and 13 weeks relative to baseline
Changes in Motivation for Physical Activity
Time frame: 25 and 13 weeks relative to baseline
Changes in Social Support
Time frame: 25 and 13 weeks relative to baseline
Changes in Self-reported Physical Activity
Time frame: 25 and 13 weeks relative to baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No. This study is a feasibility and pilot trial designed to assess acceptability, adherence, and implementation of a remote exercise intervention and to inform the design of a future larger clinical trial. The sample size is small, and the data include detailed behavioral, wearable device, and qualitative information that may increase the risk of participant re-identification. Summary-level results will be reported through publications and ClinicalTrials.gov. Plans for IPD sharing will be reconsidered for future adequately powered trials.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Schrauben, MD, MSCE principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Rehabilitation Program with Physical Activity Tracker in people with Chronic Kidney Disease 5D and Chronic Kidney Disease Stage 5, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Schrauben, MD, MSCE (2156628730, sarahsch@upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment efficiency and Retention (time frame: Enrollment efficiency time period is study duration (anticipate up to 20 moths) and retention is 12 weeks of intervention period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026; AzTrials last refreshed its copy on 3 Nov 2026.