Structured Program of Exercise for Recipients of Kidney Transplantation

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• On hemodialysis or peritoneal dialysis

• Age ≥ 50 years

• SPPB score ≤ 10

• Telephone access

• Internet access

• Having a living donor kidney

Locations
United States
California
Connie Frank Center for Kidney Transplantation at the University of California, San Francisco Medical Center
RECRUITING
San Francisco
Contact Information
Primary
Anoop Sheshadri, MD, MAS
anoop.sheshadri@ucsf.edu
415-221-4810
Backup
Gabriel Garcia
gabriel.garcia@ucsf.edu
Time Frame
Start Date: 2022-11-22
Estimated Completion Date: 2029-07
Participants
Target number of participants: 136
Treatments
Placebo_comparator: Usual Care
Patients randomized to usual care will receive recommendations for exercise based on the Surgeon General's recommendations for physical activity among adults as well as the American Heart Association and American College of Sports Medicine recommendations for older individuals or individuals with chronic conditions. These guidelines are applicable to this patient population. Patients will not receive coaching but will receive accelerometers to obtain data for comparison to the intervention groups at each time point (baseline, 8 weeks, and 3 months post-KT).
Active_comparator: Weekly Coaching
Weekly coaching per the SPaRKT protocol with titrated increases in physical activity and resistance exercise
Active_comparator: Weekly Coaching + Caregiver Participation
Weekly coaching per the SPaRKT protocol with titrated increases in physical activity and resistance exercise with the addition of caregiver participation to promote adherence and engagement
Related Therapeutic Areas
Sponsors
Leads: University of California, San Francisco

This content was sourced from clinicaltrials.gov