Physical Disability Clinical Trial
— SPaRKTOfficial title:
Structured Program of Exercise for Recipients of Kidney Transplantation
NCT number | NCT04954690 |
Other study ID # | 19-28357 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | November 22, 2022 |
Est. completion date | July 2029 |
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.
Status | Recruiting |
Enrollment | 136 |
Est. completion date | July 2029 |
Est. primary completion date | July 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Connie Frank Center for Kidney Transplantation at the University of California, San Francisco Medical Center | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | baseline, 8 weeks (post-program completion), approximately 20 weeks (3-months post-KT) | |
Primary | 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. | baseline, 8 weeks (post-program completion), approximately 20 weeks (3-months post-KT) | |
Secondary | 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. | baseline, 8 weeks (post-program completion), approximately 20 weeks (3-months post-KT) | |
Secondary | Change in Grip Strength | Grip strength will be measured by handheld dynamometer (kg force), with increased kg of force representing greater grip strength. | baseline, 8 weeks (post-program completion), approximately 20 weeks (3-months post-KT) | |
Secondary | 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. | baseline, 8 weeks (post-program completion), approximately 20 weeks (3-months post-KT) | |
Secondary | 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. | baseline, 8 weeks (post-program completion), approximately 20 weeks (3-months post-KT) | |
Secondary | 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. | baseline, 8 weeks (post-program completion), approximately 20 weeks (3-months post-KT) | |
Secondary | 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. | baseline, 8 weeks (post-program completion), approximately 20 weeks (3-months post-KT) | |
Secondary | 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. | baseline, 8 weeks (post-program completion), approximately 20 weeks (3-months post-KT) | |
Secondary | Days hospitalized after transplantation | Days hospitalized after transplantation (within 90 days). Inpatient days specifically will be measured. | approximately 20 weeks (3-months post-KT) | |
Secondary | 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. | approximately 20 weeks (3-months post-KT) |
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