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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK144325 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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:
Researchers will compare two groups to see if the exercise program leads to higher physical activity and better physical function:
Participants will:
This study may help researchers learn how to better support people waiting for kidney transplant through safe, home-based exercise programs.
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:
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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care with Physical Activity Tracker | Other | Participants in this arm will continue to receive their usual pre-transplant care provided by the transplant center. In addition, participants will receive a wrist-worn physical activity tracker to measure daily activity, including step counts. Participants will be asked to wear the activity tracker throughout the study period, but they will not receive structured exercise programming or exercise-related coaching as part of the study. |
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| Exercise Prehabilitation Program with Physical Activity Tracker | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment efficiency and Retention | 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%. | Enrollment efficiency time period is study duration (anticipate up to 20 moths) and retention is 12 weeks of intervention period |
| Acceptability of the Intervention | 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. | 12-weeks after randomization |
| Adherence | 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. | 12 weeks after randomization |
| Adverse Events Related to Intervention | Safety will be evaluated by documenting the number and type of adverse events occurring during the study period. | Up to 12 weeks after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Short Physical Performance Battery (SPPB) Score | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 30 Day Post-Transplant Composite Clinical Outcome | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Schrauben, MD, MSCE | Contact | 2156628730 | sarahsch@upenn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sarah Schrauben, MD, MSCE | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Perelman Center for Advanced Medicine | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
This study is a feasibility and pilot trial designed to assess acceptability, adherence, and implementation of a remote exercise intervention and to inform the design of a future larger clinical trial. The sample size is small, and the data include detailed behavioral, wearable device, and qualitative information that may increase the risk of participant re-identification. Summary-level results will be reported through publications and ClinicalTrials.gov. Plans for IPD sharing will be reconsidered for future adequately powered trials.
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| 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. |
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| 13 and 25 weeks relative to baseline |
| Change in Daily Physical Activity (Step Counts) | 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. | 12 weeks of intervention period |
| Changes in Health Related Quality of Life | 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. | 13 and 25 weeks relative to baseline |
| Change in Frailty Status | Physical function will be assessed using Between-group differences in Frailty status using the Fried Frailty Phenotype | 13 and 25 weeks relative to baseline |
| Change in Gait Speed | Physical function will be assessed using between-group differences in Gait speed (meters/second) | 13 and 25 weeks relative to baseline |
| Change in Chair Stand Time | Physical function will be assessed using Between-group differences in time of Five-times sit-to-stand test (seconds) | 13 and 25 weeks relative to baseline |
| Change in Handgrip Strength | Physical function will be assessed using Between-group differences of Handgrip strength (kilograms) | 13 and 25 weeks relative to baseline |
| Change in Self-Reported Physical Function | 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). | 13 and 25 weeks after baseline |
| Changes in Digital Health Literacy | 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 | 13 and 25 weeks relative to baseline |
| Changes in Health Related Quality of Life | 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. | 13 and 25 weeks relative to baseline |
| Changes in Self-Efficacy | 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. | 25 and 13 weeks relative to baseline |
| Changes in Motivation for Physical Activity | 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. | 25 and 13 weeks relative to baseline |
| Changes in Social Support | 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. | 25 and 13 weeks relative to baseline |
| Changes in Self-reported Physical Activity | 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. | 25 and 13 weeks relative to baseline |
| 30 days post transplant |
| Hospitalizations While on the Waitlist | Group differences in number of hospitalizations while on waitlist | Randomization up to 6 months (end of study) or transplantation |
| 90 day Post Transplant Composite Clinical Outcome | 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. | 90-Days Post Transplant |
| Length of Stay 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 | Time in Hospital after transplant (reported at 30 and 90 days post-transplant) |
| Waitlist Status Change to Active | Group differences of waitlist status from inactive to active prior to transplantation | Randomization until 6 months (end of study) or transplantation |
| Waitlist Total Length of Stay | 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. | Randomization until 6 months (end of study) or transplantation |
| Waitlist Death | Group differences in number of deaths while on waitlist | Randomization until 6 months (end of study) or transplantation |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016138 | Walking |
| ID | Term |
|---|---|
| D008124 | Locomotion |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D015444 | Exercise |
| D009043 | Motor Activity |
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