Structured Program of Exercise for Recipients of Kidney Transplantation

Summary

Older patients with end- stage kidney disease (ESKD) are at very high risk for functional impairment. Kidney transplantation (KT) has the potential to ameliorate the detrimental effects of ESKD on physical activity and functional status. However, KT alone may not meet the full extent of this potential, particularly for older or more impaired adults. In fact, activity declines immediately post-KT and fails to return to expected levels even 5 years post-KT. Older patients waitlisted for KT (most of whom are on dialysis) are therefore reliant on their pre-KT levels of exercise, which are also predictive of post-KT mortality.

"Prehabilitation" has been used in other surgical populations to minimize functional loss, and a structured exercise program may be beneficial in the pre- KT setting. However, few waitlisted patients are able to participate in typical exercise interventions due to barriers such as severe fatigue. Older patients have additional barriers such as further mobility impairment and requiring substantial caregiver support. Therefore for older living donor kidney transplant candidates, it is necessary to address issues such as specifics of coaching, timing, and importantly, incorporate caregiver participation.

The overall objective of this proposal is to adapt a previously developed 8- week, home- based, structured exercise program among older (≥50 years) dialysis patients awaiting living donor KT, with a focus on caregiver involvement. The investigators will trial the exercise program as compared to usual care. The investigators will then pilot the refined intervention in a total of 72 patient-caregiver dyads, 48 of whom will undergo the proposed intervention (24 with caregiver participation, 24 without). The primary outcomes for the pilot will be change in physical performance and activity from baseline to after the intervention, along with measurements of exploratory quality of life outcomes. In addition, the investigators will measure these same outcomes at 3- months post KT to evaluate for a durable effect of the intervention. An additional post-transplantation outcome of interest will be number of days hospitalized within 3 months of transplantation.

Conditions

• Kidney Transplant; Complications
• Dialysis; Complications
• Physical Disability
• Frailty Syndrome

Interventions

BEHAVIORAL

Structured Program of exercise for Recipients of Kidney Transplantation (WC)

Structured Program of exercise for Recipients of Kidney Transplantation (weekly coaching)

BEHAVIORAL

Structured Program of exercise for Recipients of Kidney Transplantation (WC + CG)

Structured Program of exercise for Recipients of Kidney Transplantation (weekly coaching + caregiver participation)

BEHAVIORAL

Usual Care

Usual Care

Sponsors & Collaborators

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Anoop Sheshadri, MD, MAS · University of California, San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-11-22

Primary Completion

2026-07-31

Completion

2029-07-31

Countries

• United States

Study Locations