Kidney Transplant Improvement Through New Exercise Training to Increase Capacity (KINETIC)

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:

• 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.

Study Overview

• Status: Recruiting
• Conditions: Kidney Transplantation; Chronic Kidney Disease Stage 5; Kidney Failure; Chronic Kidney Disease 5D; Chronic Kidney Disease Stage 4; Kidney Failure,Chronic; Renal Insufficiency Chronic; Exercise Theraphy; Waiting List; Transplant Candidate
• Intervention / Treatment: Other: Active control; Behavioral: Exercise Rehabilitation Program with Physical Activity Tracker

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Schrauben, MD, MSCE; Phone Number: 2156628730; Email: sarahsch@upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Perelman Center For Advanced Medicine
      • Contact: Sarah Schrauben, MD, MS; Phone Number: 267-324-7588; Email: sarahsch@upenn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Usual Care with Physical Activity Tracker; 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.	Other: Active control; 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.
Experimental: Exercise Prehabilitation Program with Physical Activity Tracker; 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.	Behavioral: Exercise Rehabilitation Program with Physical Activity Tracker; 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.; Other Names: walking; home-based exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%.	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.	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.	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.	Up to 12 weeks after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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	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)	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)	13 and 25 weeks relative to baseline
Change in Handgrip Strength	Physical function will be assessed using Between-group differences of Handgrip strength (kilograms)	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).	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	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.	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.	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.	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.	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.	25 and 13 weeks relative to baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
30 Day Post-Transplant Composite Clinical Outcome	The proportion of participants who experience at least one of the following events within 30 days after kidney transplant: delayed graft function (needing dialysis at any time after transplant), primary non-function (non-functioning transplant), surgical complication requiring intervention, intensive care unit (ICU) transfer, discharge to an assisted care facility, any rehospitalization after discharge from transplant hospitalization, or death. Each participant will be classified once as either: Yes (experienced ≥1 event), or No (experienced none of the listed events). The outcome will be analyzed as a binary participant-level variable.	30 days post transplant
Hospitalizations While on the Waitlist	Group differences in number of hospitalizations while on waitlist	Randomization up to 6 months (end of study) or transplantation
90 day Post Transplant Composite Clinical Outcome	The proportion of participants who experience at least one of the following events within 90 days after kidney transplant: delayed graft function (defined as need for dialysis at any time after transplant), primary non-function (non-functioning transplant), surgical complication requiring intervention, intensive care unit (ICU) transfer, discharge to an assisted care facility, any rehospitalization after discharge from the transplant hospitalization, or death. Each participant will be classified once as either: Yes (experienced one or more of the listed events), or No (experienced none of the listed events). The outcome will be analyzed as a binary participant-level variable.	90-Days Post Transplant
Length of Stay Post-Transplant	Length of stay (LOS) is defined as the number of days from the date of kidney transplant surgery to hospital discharge. LOS will be analyzed as a continuous outcome	Time in Hospital after transplant (reported at 30 and 90 days post-transplant)
Waitlist Status Change to Active	Group differences of waitlist status from inactive to active prior to transplantation	Randomization until 6 months (end of study) or transplantation
Waitlist Total Length of Stay	Group differences in the cumulative number of inpatient hospital days across all hospitalizations occurring while a participant is on the kidney transplant waitlist prior to transplant.	Randomization until 6 months (end of study) or transplantation
Waitlist Death	Group differences in number of deaths while on waitlist	Randomization until 6 months (end of study) or transplantation

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Sarah Schrauben, MD, MSCE, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: January 28, 2026
• First Submitted That Met QC Criteria: February 25, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: prehabilitation; physical function; physical activity program; home-based exercise; kidney transplant candidates; kidney transplant waiting list; pre-transplant care
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Failure, Chronic; Renal Insufficiency, Chronic; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Locomotion; Walking
• Other Study ID Numbers: 859280; R01DK144325 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No