Virtual Exercise for Kidney Transplant Candidates
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Stanford University
Disqualifiers: Nursing home, Severe low vision, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?This study is examining whether a virtually supervised exercise program can improve physical function in persons who are awaiting kidney transplant. The investigators will compare the results to a similar group of persons who receive a health education program.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Virtual Exercise for Kidney Transplant Candidates?
Research shows that prehabilitation, which includes exercise before kidney transplantation, can improve physical activity levels and reduce hospital stay after surgery. A pilot study found that participants who engaged in prehabilitation had a 64% increase in physical activity and shorter hospital stays compared to those who did not.
12345Is virtual exercise safe for kidney transplant candidates?
Exercise interventions, including home-based and virtually supervised programs, are generally considered safe for kidney transplant candidates and recipients. Studies suggest that these programs can improve physical fitness and quality of life without significant safety concerns.
12678How is the virtually supervised exercise treatment unique for kidney transplant candidates?
The virtually supervised exercise treatment is unique because it allows kidney transplant candidates to engage in a home-based exercise program with remote guidance, which is particularly beneficial for those who may have limited mobility or access to in-person facilities. This approach aims to improve physical function and readiness for surgery, potentially leading to better post-transplant outcomes.
127910Eligibility Criteria
This trial is for individuals who are on the waiting list for a kidney transplant and want to improve their physical function. It's not specified, but typically participants should be able to perform basic exercises with virtual supervision.Inclusion Criteria
I am on the kidney transplant list.
I have trouble with stairs, walking, or getting up from a chair.
I am 18 years old or older.
Exclusion Criteria
I do not speak English.
I use supplemental oxygen.
I haven't had a heart attack, major heart surgery, stroke, blood clots, hip fracture, or hip/knee replacement in the last 6 months.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive a virtually supervised exercise program or a health education program for 12 weeks
12 weeks
Virtually supervised sessions
Extended Treatment
Participants continue with the virtually supervised exercise program for an additional 12 weeks
12 weeks
Virtually supervised sessions
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study is testing if exercising under virtual supervision can help people waiting for kidney transplants get in better shape compared to those who just receive health education about staying active and healthy.
2Treatment groups
Experimental Treatment
Active Control
Group I: Virtually supervised exerciseExperimental Treatment1 Intervention
In the first half of the study (weeks 0 to 12), participants will receive a virtually supervised exercise program. In the second half of the study (weeks 13 to 24), participant will continue to receive the virtually supervised exercise program.
Group II: Health educationActive Control2 Interventions
In the first half of the study (weeks 0 to 12), participants will receive a health education program. In the second half of the study (weeks 13 to 24), participant will receive a the virtually supervised exercise program.
Virtually supervised exercise is already approved in United States for the following indications:
🇺🇸 Approved in United States as Virtually supervised exercise for:
- Improvement of physical function in kidney transplant candidates
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Stanford UniversityPalo Alto, CA
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Who Is Running the Clinical Trial?
Stanford UniversityLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
Study on the effect of pre-rehabilitation home-based on patients undergoing kidney transplantation with end-stage renal disease: A study protocol. [2023]Evaluate the feasibility of ERAS-based home exercise pre-rehabilitation in patients awaiting kidney transplantation.
Prehabilitation prior to kidney transplantation: Results from a pilot study. [2023]Prehabilitation is the process of enhancing preoperative functional capacity to improve tolerance for the upcoming stressor; it was associated with improved postoperative outcomes in a handful of studies, but never evaluated in transplantation. Kidney transplant (KT) candidates may be uniquely suited for prehabilitation because they experience a profound loss of functional capacity while waiting years on dialysis. To better understand the feasibility and effectiveness of prehabilitation in KT, we conducted a pilot study of center-based prehabilitation for candidates; this intervention consisted of weekly physical therapy sessions at an outpatient center with at-home exercises. We enrolled 24 participants; 18 participated in prehabilitation (75% of enrolled; 17% of eligible). 61% were male, 72% were African American, and mean age = 52 (SD = 12.9); 71% of participants had lower-extremity impairment, and 31% were frail. By 2 months of prehabilitation, participants improved their physical activity by 64% (P = 0.004) based on accelerometry. Participants reported high satisfaction. Among 5 prehabilitation participants who received KT during the study, length of stay was shorter than for age-, sex-, and race-matched control (5 vs 10 days; RR = 0.69; 95% CI:0.50-0.94; P = 0.02). These pilot study findings suggest that prehabilitation is feasible in pretransplant patients and may potentially be a strategy to improve post-KT outcomes.
An Integrative Literature Review of Physical Activity Recommendations for Adult Renal Transplant Recipients. [2018]To establish the current state of knowledge regarding physical activity interventions for adult kidney transplant recipients.
The FRAILMar Study Protocol: Frailty in Patients With Advanced Chronic Kidney Disease Awaiting Kidney Transplantation. A Randomized Clinical Trial of Multimodal Prehabilitation. [2021]Introduction: Frailty is very frequent among patients with chronic kidney disease (CKD) who are awaiting deceased donor kidney transplantation (KT), and transplant outcomes are worsened in those frail recipients. Frailty and poor fitness powerfully predict mortality, kidney graft survival, and healthcare utilization after KT. Intervention is essential to improve survival and quality of life for frail CKD patients, regardless of their age. Studies of post-transplant physical therapy intervention have been met with limited success, in large part due to high dropout rates. A pre-transplant clinical framework for multimodal prehabilitation interventions including physical therapy, nutritional measures, and psychological support scheduled during the KT waiting list period may improve patient retention and compliance, better mitigate the effects of frailty and poor fitness after KT, and improve main outcomes in frail CKD patients. Main Objective: To study the effectiveness, feasibility, and safety of multimodal prehabilitation (exercise, nutritional plans, psychological advice) in KT candidates. Methods: Randomized controlled clinical trial in 38 frail and 76 non-frail KT candidates. The prehabilitation program will consist of physical exercise (24 sessions, 8 weeks), nutritional supplementation, and psychological advice. The primary endpoint will be a composite achievement of clinical and functional main outcomes in frail and non-frail KT candidates at 90 days post-transplantation. Secondary outcomes include changes in exercise capacity, physical activity, gait speed, respiratory and peripheral muscle strength, muscle size, body composition, performance in activities of daily living (basic and instrumental), anxiety and depression symptoms, and health-related quality of life. Feasibility of the intervention will be also analyzed. Expected Results: Multimodal prehabilitation is a feasible and effective intervention to decrease bad outcomes at 90 days post-KT by 25 and 12.5% in frail and non-frail patients, respectively. Clinical Trial Registration: clinicaltrials.gov (NCT04701398), date: 2021, January 8th (Protocol version: Frailmar_vers2).
Prevalence and Correlates of Accelerometer-Based Physical Activity and Sedentary Time Among Kidney Transplant Recipients. [2022]Physical activity is recommended for kidney transplant recipents as it may improve outcomes including mortality, exercise capacity, muscle strength, and health-related quality of life.
Physical Activity in Kidney Transplant Recipients: A Review. [2019]Physical activity has known health benefits and is associated with reduced cardiovascular risk in the general population. Relatively few data are available for physical activity in kidney transplant recipients. Compared to the general population, physical activity levels are lower overall in kidney recipients, although somewhat higher compared to the dialysis population. Recipient comorbid condition, psychosocial and socioeconomic factors, and long-term immunosuppression use negatively affect physical activity. Physical inactivity in kidney recipients may be associated with reduced quality of life, as well as increased mortality. Interventions such as exercise training appear to be safe in kidney transplant recipients and are associated with improved quality of life and exercise capacity. Additional studies are required to evaluate long-term effects on cardiovascular risk factors and ultimately cardiovascular disease outcomes and patient survival. Currently available data are characterized by wide variability in the interventions and outcome measures investigated in studies, as well as use of small sample-sized cohorts. These limitations highlight the need for larger studies using objective and standardized measures of physical activity and physical fitness in kidney transplant recipients.
A pilot randomised controlled trial of a structured, home-based exercise programme on cardiovascular structure and function in kidney transplant recipients: the ECSERT study design and methods. [2021]Cardiovascular disease (CVD) is a major cause of morbidity and mortality in kidney transplant recipients (KTRs). CVD risk scores underestimate risk in this population as CVD is driven by clustering of traditional and non-traditional risk factors, which lead to prognostic pathological changes in cardiovascular structure and function. While exercise may mitigate CVD in this population, evidence is limited, and physical activity levels and patient activation towards exercise and self-management are low. This pilot study will assess the feasibility of delivering a structured, home-based exercise intervention in a population of KTRs at increased cardiometabolic risk and evaluate the putative effects on cardiovascular structural and functional changes, cardiorespiratory fitness, quality of life, patient activation, healthcare utilisation and engagement with the prescribed exercise programme.
Exercise training in patients after kidney transplantation. [2021]Kidney transplantation is the treatment of choice for patients with end-stage renal disease. Next to the risk of allograft failure, major obstacles for disease-free survival after kidney transplantation include a higher incidence of cancer, infection and cardiovascular events. Risk factors for adverse clinical outcomes include pre-existent comorbidities, the introduction of an immunodeficient status and (lack of) lifestyle changes after transplantation. Indeed, physical inactivity and poor physical fitness are important targets to address in order to improve clinical outcomes after kidney transplantation. This review summarizes the current evidence on exercise training after kidney transplantation, derived from randomized controlled trials. As much as possible, results are discussed in the perspective of the Standardized Outcomes in Nephrology-Transplantation core outcomes, which were recently described as critically important outcome domains for trials in kidney transplant recipients.
Graded exercise testing and training after renal transplantation: a preliminary study. [2019]Aerobic exercise training has been used as part of the treatment for a variety of chronic disorders, most notably cardiovascular disease. In order to determine the feasibility and utility of regular exercise after renal transplantation, the responses of 10 patients to graded exercise testing were compared before training (T1), immediately after a program of supervised exercise training (T2), and a mean of 2.2 years after completion of the supervised program (T3). Supervised exercise sessions began a mean of 17 days postoperatively and continued for a mean of 5.5 weeks. Patients were encouraged to continue regular unsupervised exercise thereafter. All patients easily tolerated the supervised exercise sessions, which consisted of treadmill walking and cycle ergometry. Exercise capacity improved 90% between T1 and T2 and an additional 12% between T2 and T3. On the average, patients achieved a normal exercise capacity by 8 weeks after transplantation. Of the 10 patients, 7 had continued regular exercise training at T3. The observed increase in aerobic exercise capacity was probably related to improved renal function, an increased hemoglobin concentration, and the surgical healing process as well as the exercise training. We conclude that supervised exercise training for selected patients after renal transplantation is feasible and worthwhile.
Face-to-Face Mentoring, Remotely Supervised Home Exercise Prehabilitation to Improve Physical Function in Patients Awaiting Kidney Transplantation: A Randomized Clinical Trial. [2022]This study aims to explore the feasibility, safety, and effectiveness of home exercise prehabilitation on a new social platform for remote guidance to optimize the physical function of patients with end-stage renal disease awaiting kidney transplantation and provide scientific guidance on home prehabilitation exercises for patients awaiting kidney transplantation.