Recruiting

Exercise Program

Sponsor:

UCLA

Code:

NCT04954690

Conditions

Kidney Transplant; Complications

Dialysis; Complications

Physical Disability

Frailty Syndrome

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

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

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

Usual Care

Study Details

Brief 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

Study ID

NCT04954690

Start date

Nov 22, 2022

Status verified date

Oct, 2023

Completion date

Jul, 2029

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • On hemodialysis or peritoneal dialysis
  • Age ≥ 50 years
  • SPPB score ≤ 10
  • Telephone access
  • Internet access
  • Having a living donor kidney

Exclusion Criteria:

  • Already in an exercise program
  • Non-English speakers

Study Design

Enrollment

136 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

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

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

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

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

Usual Care

Usual Care

Primary outcome measure

  • Change in Short Physical Performance Battery (SPPB) [ Time Frame: baseline, 8 weeks (post-program completion), approximately 20 weeks (3-months post-KT) ]
  • Change in Step Count [ Time Frame: baseline, 8 weeks (post-program completion), approximately 20 weeks (3-months post-KT) ]

Central Contacts and Locations

Central contacts

Locations

Connie Frank Center for Kidney Transplantation at the University of California, San Francisco Medical Center

Recruiting

San Francisco, California, United States, 94143

Contacts

Principal Investigator:

Anoop Sheshadri, MD, MAS

More Information

Sponsor

University of California, San Francisco

Last update posted

Oct 16, 2023

Last verified

Oct, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2023-10-16.