Exercise Training for Kidney Transplant Candidates
This study, called KINETIC, is looking at whether a home-based exercise program can help adults aged 60 and older who are waiting for a kidney transplant. Participants will either join a 12-week home exercise program with an online platform and activity tracker (Exercise Rehabilitation Program with Physical Activity Tracker) or continue their usual care while wearing an activity tracker (Active control). The main goal is to see if this exercise program is safe, easy to use, and if people will stick with it. This study aims to enroll 60 participants who receive transplant care at Penn Medicine, are on the kidney transplant waiting list, and can walk.
- Study design
- This is an interventional study, meaning participants will receive a specific intervention. It aims to enroll 60 participants.
- What's involved
- Participants will either take part in a 12-week home-based exercise program or continue their usual care. Both groups will wear a wrist-worn physical activity tracker.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure how well participants stick with the program and how acceptable it is for 12 weeks after they are randomly assigned to a group.
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Kidney Transplant Improvement Through New Exercise Training to Increase Capacity
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Sarah Schrauben, MD, MSCE · PRINCIPAL_INVESTIGATOR · University of Pennsylvania
Who to contact
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Inclusion
Exclusion
What this trial measures
- Enrollment efficiency and RetentionEnrollment 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 Intervention12-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.
- Adherence12 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 InterventionUp to 12 weeks after randomization
Safety will be evaluated by documenting the number and type of adverse events occurring during the study period.