Trials / Not Yet Recruiting

Not Yet RecruitingNCT07446296

Kidney Transplant Improvement Through New Exercise Training to Increase Capacity

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

Status: Not Yet Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 60 (estimated)

Sponsor: University of Pennsylvania · Academic / Other
Sex: All
Age: 60 Years
Healthy volunteers: Not accepted

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. 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. .

Conditions

Interventions

Type	Name	Description
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	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.

Timeline

Start date: 2026-02-01
Primary completion: 2028-03-01
Completion: 2028-05-01
First posted: 2026-03-03
Last updated: 2026-03-03

Source: ClinicalTrials.gov record NCT07446296. Inclusion in this directory is not an endorsement.