Kidney Transplant Improvement Through New Exercise Training to Increase Capacity

NCT07446296 | Recruiting DMC

• 2 other identifiers: 859280R01DK144325
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Failure; Kidney Failure,Chronic; Chronic Kidney Disease Stage 4; Kidney Transplantation; Waiting List; Transplant Candidate; Exercise Theraphy; Chronic Kidney Disease 5D; Chronic Kidney Disease Stage 5; Renal Insufficiency Chronic

Keywords

kidney transplant candidates; prehabilitation; home-based exercise; physical activity program; kidney transplant waiting list; pre-transplant care; physical function

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (14)

• Change in Short Physical Performance Battery (SPPB) Score

  13 and 25 weeks relative to baseline

• Change in Daily Physical Activity (Step Counts)

  12 weeks of intervention period

• Changes in Health Related Quality of Life

  13 and 25 weeks relative to baseline

• Change in Frailty Status

  13 and 25 weeks relative to baseline

• Change in Gait Speed

  13 and 25 weeks relative to baseline

Other Outcomes (7)

• 30 Day Post-Transplant Composite Clinical Outcome

  30 days post transplant

• Hospitalizations While on the Waitlist

  Randomization up to 6 months (end of study) or transplantation

• 90 day Post Transplant Composite Clinical Outcome

  90-Days Post Transplant

Study Arms (2)

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.

Other: Active control

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.

Behavioral: Exercise Rehabilitation Program with Physical Activity Tracker

Interventions

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.

Also known as: walking, home-based exercise

Exercise Prehabilitation Program with Physical Activity Tracker

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.

Usual Care with Physical Activity Tracker

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Failure, Chronic

Interventions

Walking

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Sarah Schrauben, MD, MSCE

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Schrauben, MD, MSCE

CONTACT

2156628730; sarahsch@upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: March 3, 2026
• Study Start: March 24, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)