Overview
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.
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.
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Eligibility
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
