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NCT Number: NCT07446296

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.

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Key information

About this study

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.

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise Rehabilitation Program with Physical Activity Tracker

Behavioral

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

Active Control

Other

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.

Primary outcomes

  1. 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%.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Change in Short Physical Performance Battery (SPPB) Score

    Time frame: 13 and 25 weeks relative to baseline

    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.

  2. Change in Daily Physical Activity (Step Counts)

    Time frame: 12 weeks of intervention period

    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.

  3. Changes in Health Related Quality of Life

    Time frame: 13 and 25 weeks relative to baseline

    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.

  4. Change in Frailty Status

    Time frame: 13 and 25 weeks relative to baseline

    Physical function will be assessed using Between-group differences in Frailty status using the Fried Frailty Phenotype

  5. Change in Gait Speed

    Time frame: 13 and 25 weeks relative to baseline

    Physical function will be assessed using between-group differences in Gait speed (meters/second)

  6. Change in Chair Stand Time

    Time frame: 13 and 25 weeks relative to baseline

    Physical function will be assessed using Between-group differences in time of Five-times sit-to-stand test (seconds)

  7. Change in Handgrip Strength

    Time frame: 13 and 25 weeks relative to baseline

    Physical function will be assessed using Between-group differences of Handgrip strength (kilograms)

  8. Change in Self-Reported Physical Function

    Time frame: 13 and 25 weeks after baseline

    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).

  9. Changes in Digital Health Literacy

    Time frame: 13 and 25 weeks relative to baseline

    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

  10. Changes in Health Related Quality of Life

    Time frame: 13 and 25 weeks relative to baseline

    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.

  11. Changes in Self-Efficacy

    Time frame: 25 and 13 weeks relative to baseline

    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.

  12. Changes in Motivation for Physical Activity

    Time frame: 25 and 13 weeks relative to baseline

    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.

  13. Changes in Social Support

    Time frame: 25 and 13 weeks relative to baseline

    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.

  14. Changes in Self-reported Physical Activity

    Time frame: 25 and 13 weeks relative to baseline

    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.

Other outcomes

  1. 30 Day Post-Transplant Composite Clinical Outcome

    Time frame: 30 days post transplant

    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.

  2. Hospitalizations While on the Waitlist

    Time frame: Randomization up to 6 months (end of study) or transplantation

    Group differences in number of hospitalizations while on waitlist

  3. 90 day Post Transplant Composite Clinical Outcome

    Time frame: 90-Days Post Transplant

    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.

  4. Length of Stay Post-Transplant

    Time frame: Time in Hospital after transplant (reported at 30 and 90 days 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

  5. Waitlist Status Change to Active

    Time frame: Randomization until 6 months (end of study) or transplantation

    Group differences of waitlist status from inactive to active prior to transplantation

  6. Waitlist Total Length of Stay

    Time frame: Randomization until 6 months (end of study) or transplantation

    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.

  7. Waitlist Death

    Time frame: Randomization until 6 months (end of study) or transplantation

    Group differences in number of deaths while on waitlist

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Schrauben, MD, MSCE

CONTACT

[email protected]

2156628730

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

KINETIC -- Kidney Transplant Improvement Through New Exercise Training to Increase Capacity

Acronym: KINETIC

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 3, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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