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.
be at least 60 years old
receive transplant care at Penn Medicine
be on the kidney transplant waiting list
speak and comprehend English
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
Parallel
Exercise Rehabilitation Program with Physical Activity Tracker
BehavioralParticipants 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.
Active control
Other interventionParticipants 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.
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%.
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.
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.
Adverse Events Related to Intervention
Safety will be evaluated by documenting the number and type of adverse events occurring during the study period.
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.
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.
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.
Change in Frailty Status
Physical function will be assessed using Between-group differences in Frailty status using the Fried Frailty Phenotype
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.
Hospitalizations While on the Waitlist
Group differences in number of hospitalizations while on waitlist
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.
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
Click on the lead sponsor to view all of their trials.
University of Pennsylvania
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
