Structured Program of Exercise for Recipients of Kidney Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- Change in Step Count
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
This is an exercise intervention. Therefore participation and coaching cannot be masked. In order to ensure safety, the primary nephrologist and dialysis clinic will be informed of patients participation in the trial. However, they will not be involved with coaching or assessing outcomes.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •On hemodialysis or peritoneal dialysis
- •Age ≥ 50 years
- •SPPB score ≤ 10
- •Telephone access
- •Internet access
- •Having a living donor kidney
排除标准
- •Already in an exercise program
- •Non-English speakers
结局指标
主要结局
Change in Step Count
时间窗: baseline, 8 weeks (post-program completion), approximately 20 weeks (3-months post-KT)
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.
Change in Short Physical Performance Battery (SPPB)
时间窗: baseline, 8 weeks (post-program completion), approximately 20 weeks (3-months post-KT)
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.
次要结局
- Change in Dialysis Symptoms Index (DSI) score(baseline, 8 weeks (post-program completion), approximately 20 weeks (3-months post-KT))
- Change in lower urinary tract symptoms (LUTS questionnaire)(baseline, 8 weeks (post-program completion), approximately 20 weeks (3-months post-KT))
- Change in Short Form-36 (SF-36) score(baseline, 8 weeks (post-program completion), approximately 20 weeks (3-months post-KT))
- Change in Center for Epidemiological Studies- Depression (CES-D) score(baseline, 8 weeks (post-program completion), approximately 20 weeks (3-months post-KT))
- Change in Montreal Cognitive Assessment (MoCA)(baseline, 8 weeks (post-program completion), approximately 20 weeks (3-months post-KT))
- Change in 6 minute walk distance (6MWD)(baseline, 8 weeks (post-program completion), approximately 20 weeks (3-months post-KT))
- Change in Grip Strength(baseline, 8 weeks (post-program completion), approximately 20 weeks (3-months post-KT))
- Days in rehabilitation after transplantation(approximately 20 weeks (3-months post-KT))
- Days hospitalized after transplantation(approximately 20 weeks (3-months post-KT))