Structured Program of Exercise for Recipients of Kidney Transplantation

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT04954690
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Structured Program of exercise for Recipients of Kidney Transplantation (WC) — BEHAVIORAL
    Structured Program of exercise for Recipients of Kidney Transplantation (weekly coaching)
  • Structured Program of exercise for Recipients of Kidney Transplantation (WC + CG) — BEHAVIORAL
    Structured Program of exercise for Recipients of Kidney Transplantation (weekly coaching + caregiver participation)
  • Usual Care — BEHAVIORAL
    Usual Care

Study Details

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.

Key Dates

Start date
Nov 22, 2022
Status verified
Oct 2023
Primary completion
Jul 31, 2026
Completion
Jul 31, 2029

Study Design

Enrollment
136 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Connie Frank Center for Kidney Transplantation at the University of California, San Francisco Medical CenterSan FranciscoCalifornia94143
Anoop Sheshadri, MD, MAS
[email protected]
415-221-4810
Gabriel Garcia
[email protected]
Anoop Sheshadri, MD, MAS (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Francisco, CA

By research site
Connie Frank Center for Kidney Transplantation at the University of California, San Francisco Medical Center· San Francisco, CA

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