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Kidney Transplant; ComplicationsSPaRKTNCT04954690

Structured Program of Exercise for Recipients of Kidney Transplantation

A study testing Structured Program of exercise for Recipients of Kidney Transplantation (WC) and Structured Program of exercise for Recipients of Kidney Transplantation (WC + CG) in people with Kidney Transplant; Complications and Dialysis; Complications, run by University of California, San Francisco at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Structured Program of exercise for Recipients of Kidney Transplantation (WC) and Structured Program of exercise for Recipients of Kidney Transplantation (WC + CG)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
136 participants
Where
1 siteUnited States
Study dates
22 Nov 2022to Jul 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Already in an exercise program
  • Non-English speakers

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Anoop Sheshadri, MD, MAS contact

415-221-4810 ext. 22576

anoop.sheshadri@ucsf.edu

Gabriel Garcia contact

gabriel.garcia@ucsf.edu

United States1 site, 1 recruiting
  • Connie Frank Center for Kidney Transplantation at the University of California, San Francisco Medical Center

    San Francisco, California, 94143

    Anoop Sheshadri, MD, MAS, 415-221-4810 ext. 22576, anoop.sheshadri@ucsf.edu

    Gabriel Garcia, Gabrial.Garcia@Ucsf.edu

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

The investigators will conduct a randomized clinical trial of 72 eligible participants to test SPaRKT versus usual care. The primary outcome will be ascertained at completion of the 8-week program and at 3 months post-KT. This study will provide the successful completion rate of weekly coaching as well as estimates of the impact of SPaRKT as compared to usual care. This proposal is powered primarily for change in physical function and change in walking as determined by accelerometers.

Prior to the trial, the investigators will first conduct an "adaptation" phase where study personnel recruit 10-15 paired patient-caregiver dyads to work out any logistical issues with the intervention and work on incorporating caregiver participation. This initial adaptation phase will involve focus groups of each individual wave. In addition, participants and caregivers in the adaptation portion of the study will be asked to give weekly feedback on the intervention, delivered through semi-scripted qualitative interviews of participants and caregivers. Among the items the investigators will attempt to ascertain will be: appropriate length of discussion, preferred method (phone vs video), and preferred feedback during health coaching. The investigators will conduct a final focus group interview of all participants in the adaptation phase to provide consensus on SPaRKT prior to the randomized controlled trial.

Pre-intervention: At time of enrollment, study personnel will provide information to all patients and caregivers on: 1) potential benefits of exercise and increasing activity, 2) the association between poor physical function and adverse outcomes in ESKD and specifically in KT, 3) the typical course of changes in physical function and activity post-KT, 4) general recommendations for activity. The investigators will review patient records for dialysis prescription, laboratory results, comorbid conditions, and medications. All participants will be given a Fitbit Inspire 2 (Fitbit, Inc.) accelerometer and instructed in calibration and use. The Fitbit Inspire 2 is similar to the older model (now discontinued) Fitbit Zip, in that it can be placed on a lower extremity. The Fitbit Zip has been validated in older, community-dwelling adults, and is accurate in individuals with slower walking. Participants will be asked to record activity for a one week lead-in period immediately prior to baseline assessment.

SPaRKT (intervention): Participants and caregivers will be guided through video exercises adapted for hemodialysis and peritoneal dialysis patients from the Strong for Life™ series of exercise videos to determine starting resistance band level, demonstrate proper positioning, and provide instruction on adjusting resistance. Each participant will engage in the videos a second time to enforce proper positioning. The Strong for Life™ videos were developed for sedentary older adults with physical disability. The adapted video series will consist of 11 exercises incorporating movement patterns used in daily activities. Some of these exercises use resistance bands. Study personnel will provide Thera-bands™ in 3 levels of resistance to each participant. Starting resistance and subsequent progression will be adapted from the Strong for Life™ protocol; a health coach will ask participants to increase the level of resistance when they are able to perform 12-15 repetitions of an exercise without loss of proper execution. Participants will be instructed to exercise using the these exercise videos 3 times per week for the 8-week intervention period, a dose found to be safe and effective in improving functional status among older adults post-hip fracture.

A health coach will be assigned to each participant in SPaRKT as the primary contact for counseling, feedback, and assistance. The health coach will call the participant once per week using a semi-structured script which will be refined during the adaptation phase. For Aim 1 and for the WC+CG group in Aims 2 and 3, caregivers will be included on calls. Participants will be counseled to increase their average daily steps by 10% for the next week's goal, starting from their baseline activity during the lead-in period. Participants will be instructed to adhere to participation in the exercise program, including with the Strong for Life™ video. Participants in SPaRKT will have recommendations for gradual increases of exercise per their individual health coach as guided by the protocol for 8 weeks. Afterwards, they will be asked to maintain exercise until KT.

Caregiver participation: For the Weekly Coaching + Caregiver Participation (WC+CG) arm in the intervention, caregivers will be asked to participate along with the older adult they are paired with. For the first week, personnel will request that caregivers keep track of patient activity logs and participate in weekly coaching sessions. During these sessions, a health coach will ask caregivers to plan how their patient can reach next week's activity and exercise goals. For later weeks, a health coach will encourage caregivers to 1) perform mid-week checks to ensure that patients will meet their targets, 2) take and increase number of walks with the patient in a stepwise fashion and 3) accompany the patient for exercise sessions.

Participant randomization. For the trial, participants will be randomized to SPaRKT (weekly coaching, WC: N=24, weekly coaching + caregivers, WC+CG: N=24) or usual care (N=24) with more patients in SPaRKT in order to have more experience working through the logistics of the intervention. Random assignments will be generated prior to the study using a computerized randomization scheme with assignments placed into sequentially numbered sealed envelopes. Assignment will be performed after living donor KT is scheduled and baseline assessment of outcomes has been performed.

For the WC+CG group, caregivers in the WC+CG group will be given guidelines based on feedback from the adaptation phase.

Usual Care: Patients randomized to usual care will receive recommendations for exercise based on the Surgeon General's recommendations for physical activity among adults5 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).

Being tested
Structured Program of exercise for Recipients of Kidney Transplantation (WC), Structured Program of exercise for Recipients of Kidney Transplantation (WC + CG), Usual Care
Medical subject headings
Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called WC

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

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

    Also called WC+CG

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

  • Usual CareBehavioural

    Usual Care

Study groups in NCT04954690
Study groupRoleWhat they receive
Usual CarePlacebo comparatorPatients 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).
Receives: Behavioral: Usual Care
Weekly CoachingActive comparatorWeekly coaching per the SPaRKT protocol with titrated increases in physical activity and resistance exercise
Receives: Behavioral: Structured Program of exercise for Recipients of Kidney Transplantation (WC)
Weekly Coaching + Caregiver ParticipationActive comparatorWeekly 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
Receives: Behavioral: Structured Program of exercise for Recipients of Kidney Transplantation (WC + CG)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: baseline, 8 weeks (post-program completion), approximately 20 weeks (3-months post-KT)

Secondary outcomes (9)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: baseline, 8 weeks (post-program completion), approximately 20 weeks (3-months post-KT)

  5. Change in Dialysis Symptoms Index (DSI) score

    The Dialysis Symptoms Index (DSI) contains 30 items, each of which targets a specific physical or emotional symptom. Patients are asked to report the presence (yes/no) of each symptom at any time during the previous 7 days. Using a five-point Likert scale (1 = "not at all bothersome" to 5 = "bothers very much"), the severity of each symptom reported as being present is assessed by asking patients to rate the degree to which the symptom is bothersome. Scores can therefore range from 0 to 150, with higher scores being representative of more symptoms and more bothersome symptoms.

    Measured: baseline, 8 weeks (post-program completion), approximately 20 weeks (3-months post-KT)

  6. Change in lower urinary tract symptoms (LUTS questionnaire)

    This questionnaire measures lower urinary tract symptoms of interest, including urinary frequency, incontinence, hesitance, and bother, with higher scores indicating more or more bothersome symptoms.

    Measured: baseline, 8 weeks (post-program completion), approximately 20 weeks (3-months post-KT)

  7. Change in Montreal Cognitive Assessment (MoCA)

    Change in cognition per the Montreal Cognitive Assessment (MoCA). The MoCA is a is a brief 30-question test that takes around 10 to 12 minutes to complete and helps assess people for dementia. Scores range from 0 to 30 with scores of 26 and above are generally considered "normal" with scores below 26 implying some degree of cognitive impairment.

    Measured: baseline, 8 weeks (post-program completion), approximately 20 weeks (3-months post-KT)

  8. Days hospitalized after transplantation

    Days hospitalized after transplantation (within 90 days). Inpatient days specifically will be measured.

    Measured: approximately 20 weeks (3-months post-KT)

  9. Days in rehabilitation after transplantation

    Days in rehabilitation after transplantation (within 90 days). Days in skilled nursing facility or rehabilitation centers specifically will be measured. Outpatient rehabilitation or physical therapy will be considered separately.

    Measured: approximately 20 weeks (3-months post-KT)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2021
  2. Study start22 Nov 2022
  3. Primary completionJul 2026 (estimated)
  4. Study completionJul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
136 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04954690
Sponsor's protocol ID
19-28357
Acronym
SPaRKT
Status last verified
Oct 2023
First submitted
29 Jun 2021
Last updated
16 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in publications after deidentification will be shared (texts, tables, figures, appendices, etc).

Questions about this trial

What is this clinical trial studying?

A study testing Structured Program of exercise for Recipients of Kidney Transplantation (WC) and Structured Program of exercise for Recipients of Kidney Transplantation (WC + CG) in people with Kidney Transplant; Complications and Dialysis; Complications, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anoop Sheshadri, MD, MAS (415-221-4810 ext. 22576, anoop.sheshadri@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2023.

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