Chronic Kidney Disease 5D, Chronic Kidney Disease Stage 4, Chronic Kidney Disease Stage 5, Exercise Theraphy, Kidney Failure, Kidney Failure,Chronic, Kidney Transplantation, Renal Insufficiency Chronic, Transplant Candidate, Waiting List
Conditions
Keywords
kidney transplant candidates, prehabilitation, home-based exercise, physical activity program, kidney transplant waiting list, pre-transplant care, physical function
Brief 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. .
Interventions
BEHAVIORALExercise 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.
OTHERActive 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.
Sponsors
University of Pennsylvania
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment efficiency and Retention | 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%. |
| Acceptability of the Intervention | 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. |
| Adherence | 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. |
| Adverse Events Related to Intervention | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Short Physical Performance Battery (SPPB) Score | 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. |
| Change in Daily Physical Activity (Step Counts) | 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. |
| Changes in Health Related Quality of Life | 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. |
| Change in Frailty Status | 13 and 25 weeks relative to baseline | Physical function will be assessed using Between-group differences in Frailty status using the Fried Frailty Phenotype |
| Change in Gait Speed | 13 and 25 weeks relative to baseline | Physical function will be assessed using between-group differences in Gait speed (meters/second) |
| Change in Chair Stand Time | 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) |
| Change in Handgrip Strength | 13 and 25 weeks relative to baseline | Physical function will be assessed using Between-group differences of Handgrip strength (kilograms) |
| Change in Self-Reported Physical Function | 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). |
| Changes in Digital Health Literacy | 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 |
| Changes in Self-Efficacy | 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. |
| Changes in Motivation for Physical Activity | 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. |
| Changes in Social Support | 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. |
| Changes in Self-reported Physical Activity | 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. |
Countries
United States
Contacts
CONTACTSarah Schrauben, MD, MSCE
PRINCIPAL_INVESTIGATORSarah Schrauben, MD, MSCE
University of Pennsylvania
Outcome results
None listed