Structured Program of Exercise for Recipients of Kidney Transplantation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorUniversity of California, San Francisco

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

On hemodialysis or peritoneal dialysis

Age ≥ 50 years

SPPB score ≤ 10

Telephone access

Disqualifiers

Already in an exercise program

Non-English speakers

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

136 Participants
are divided into 3 treatment groups
Group A: Usual CarePlacebo comparator 1 intervention
Group B: Weekly CoachingActive comparator 1 intervention
Group C: Weekly Coaching + Caregiver ParticipationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Short Physical Performance Battery (SPPB)

The Short Physical Performance Battery (SPPB) is a composite score ranging from 0-12, with three tests which measure: 1) gait speed, 2) timed sit to stand, and 3) balance. Each individual component can be scored from 0-4 with a total score of 0-12, with higher numbers representing better physical performance.

Time frame
baseline, 8 weeks (post-program completion), approximately 20 weeks (3-months post-KT)
2

Change in Step Count

Change in Step Count (determined by accelerometer). Step counts will be measured as continuous variables, with higher step count meaning a higher level of activity.

Time frame
baseline, 8 weeks (post-program completion), approximately 20 weeks (3-months post-KT)

Secondary outcomes

1

Change in 6 minute walk distance (6MWD)

The six-minute walk test (6MWT) measures the distance in meters an individual is able to walk over a total of six minutes on a hard, flat surface. Higher distances achieved are considered better.

Time frame
baseline, 8 weeks (post-program completion), approximately 20 weeks (3-months post-KT)
2

Change in Grip Strength

Grip strength will be measured by handheld dynamometer (kg force), with increased kg of force representing greater grip strength.

Time frame
baseline, 8 weeks (post-program completion), approximately 20 weeks (3-months post-KT)
3

Change in Short Form-36 (SF-36) score

The Short Form-36 (SF-36) is a generic health score to measure global functioning consisting of 36 questions measuring eight domains of health status: physical functioning (10 items); physical role limitations (four items); bodily pain (two items); general health perceptions (five items); energy/vitality (four items); social functioning (two items); emotional role limitations (three items) and mental health (five items). A scoring algorithm is used to convert the raw scores into the eight dimensions listed above. The scores are transformed to a range from zero where the respondent has the worst possible health to 100 where the respondent is in the best possible health.

Time frame
baseline, 8 weeks (post-program completion), approximately 20 weeks (3-months post-KT)
4

Change in Center for Epidemiological Studies- Depression (CES-D) score

The Center for Epidemiological Studies- Depression (CES-D) is a 20-item measure that asks caregivers to rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms.

Time frame
baseline, 8 weeks (post-program completion), approximately 20 weeks (3-months post-KT)

Other outcomes

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