Kidney Transplant Improvement Through New Exercise Training to Increase Capacity

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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• Change in Short Physical Performance Battery (SPPB) Score [Срок оценки: 13 and 25 weeks relative to baseline]
• Change in Daily Physical Activity (Step Counts) [Срок оценки: 12 weeks of intervention period]
• Changes in Health Related Quality of Life [Срок оценки: 13 and 25 weeks relative to baseline]
• Change in Frailty Status [Срок оценки: 13 and 25 weeks relative to baseline]
• Change in Gait Speed [Срок оценки: 13 and 25 weeks relative to baseline]
• Change in Chair Stand Time [Срок оценки: 13 and 25 weeks relative to baseline]
• Change in Handgrip Strength [Срок оценки: 13 and 25 weeks relative to baseline]
• Change in Self-Reported Physical Function [Срок оценки: 13 and 25 weeks after baseline]
• Changes in Digital Health Literacy [Срок оценки: 13 and 25 weeks relative to baseline]
• Changes in Health Related Quality of Life [Срок оценки: 13 and 25 weeks relative to baseline]
• Changes in Self-Efficacy [Срок оценки: 25 and 13 weeks relative to baseline]
• Changes in Motivation for Physical Activity [Срок оценки: 25 and 13 weeks relative to baseline]