Exercise for Chronic Kidney Disease
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen ByJeanie Park, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Emory University
Must not be taking: Bicarbonate, Central α-agonists, Immunosuppressives
Disqualifiers: Severe CKD, Heart failure, Anemia, others
No Placebo Group
Prior Safety Data
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?This trial aims to help people with chronic kidney disease improve their ability to exercise. It uses regular physical activity and a substance similar to baking soda to make it easier for their muscles to get enough blood during exercise.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, such as central α-agonists (like clonidine) and immunosuppressive medications (like steroids and biologics). If you are on these medications, you may need to discuss alternatives with your doctor.
What data supports the effectiveness of exercise as a treatment for chronic kidney disease?
Research shows that exercise can improve physical function, fitness, and quality of life in people with chronic kidney disease. It may also help with blood pressure control and mental health, although more studies are needed to confirm these benefits.
12345Is exercise safe for people with chronic kidney disease?
Exercise is generally considered safe for people with chronic kidney disease, including those on dialysis, with no reports of serious injury. However, some common minor issues like low blood pressure and muscle cramps have been noted during exercise sessions.
46789How is the exercise treatment for chronic kidney disease different from other treatments?
Exercise treatment for chronic kidney disease is unique because it focuses on improving physical function and quality of life through physical activity, rather than using medication. It aims to enhance cardiovascular health, muscle strength, and overall well-being, which are often neglected in standard care for CKD patients.
3491011Eligibility Criteria
This trial is for sedentary adults with stable chronic kidney disease (CKD) or healthy individuals as controls. CKD participants should have a steady kidney function, normal serum bicarbonate levels, and may have hypertension. Excluded are those with severe obesity, uncontrolled high blood pressure, recent surgery, pregnancy plans, certain heart conditions or metal implants that affect MRI scanning.Inclusion Criteria
I either have chronic kidney disease or I do not have any kidney disease.
You don't regularly exercise, meaning you exercise for less than 20 minutes, twice a week.
My kidney function is stable and my blood's bicarbonate level is within the normal range.
+1 more
Exclusion Criteria
You have a condition called metabolic alkalosis.
Your blood has low levels of hemoglobin, which is less than 10 grams per deciliter.
My BMI is over 40.
+21 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline Assessment
Baseline measurements in healthy participants without CKD will be measured and compared to participants with CKD
1 week
1 visit (in-person)
Treatment
Participants with CKD undergo exercise training for 20-45 minutes, 3 times per week, for 12 weeks, with either sodium bicarbonate or placebo
12 weeks
36 visits (in-person)
Follow-up
Participants are monitored for changes in exercise capacity, MSNA, IL-6, blood pressure, T2water, lean body mass, and exercise pressor reflex
4 weeks
Participant Groups
The study explores how exercise affects people with CKD compared to healthy controls. It tests whether exercise training or sodium bicarbonate supplementation can improve the body's response to physical activity in CKD patients versus a placebo group.
3Treatment groups
Experimental Treatment
Active Control
Group I: Exercise Training plus Sodium BicarbonateExperimental Treatment2 Interventions
Participants with CKD will undergo exercise training for 20-45 minutes, 3 times per week, for 12 weeks. Additionally, participants take 650-1300 mg of sodium bicarbonate twice daily.
Group II: Exercise Training plus PlaceboActive Control2 Interventions
Participants with CKD will undergo exercise training for 20-45 minutes, 3 times per week, for 12 weeks. Additionally, participants take placebo tablets to match 650-1300 mg of sodium bicarbonate twice daily.
Group III: Healthy controlActive Control1 Intervention
Baseline measurements in healthy participants without CKD will be measured and compared to participants with CKD. Healthy controls will not receive any interventions.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Emory ClinicAtlanta, GA
Atlanta VA Medical CenterDecatur, GA
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Who Is Running the Clinical Trial?
Emory UniversityLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
References
Effect of an exercise rehabilitation program on physical function over 1 year in chronic kidney disease: an observational study. [2022]Exercise rehabilitation may help maintain physical function in chronic kidney disease (CKD), but long-term clinical effectiveness is unknown. We evaluated the effect of an exercise rehabilitation program on physical function over 1 year in individuals with CKD.
Advancing Exercise Science for Better Health Outcomes Across the Spectrum of Chronic Kidney Disease. [2023]Despite over 30 years of evidence for improvements in physical function, physical fitness, and health-related quality of life with exercise training in individuals with chronic kidney disease, access to dedicated exercise training programs remains outside the realm of standard of care for most kidney care programs. In this review, we explore possible reasons for this by comparing approaches in other chronic diseases where exercise rehabilitation has become the standard of care, identifying enablers and factors that need to be addressed for continued growth in this area, and discussing knowledge gaps for future research. For exercise rehabilitation to be relevant to all stakeholders and become a sustainable component of kidney care, a focus on the effect of exercise on clinically relevant outcomes that are prioritized by individuals living with kidney disease, use of evidence-based implementation strategies for diverse settings and populations, and approaching exercise as a medical therapy are required.
Exercise therapy in individuals with chronic kidney disease: a systematic review and synthesis of the research evidence. [2018]Chronic kidney disease (CKD) is becoming a serious health problem throughout the world and is one of the most potent known risk factors for cardiovascular disease (CVD) which is considered the leading cause of morbidity and mortality in this cohort of patients. Additional independent risk factors for poor health outcomes among many include diabetes, physical inactivity and physical dysfunction. Physical inactivity partly contributes to the accelerated deterioration of physical function in people in all stages of CKD, to levels that significantly impact on clinically and patient important outcomes such as morbidity, employment, quality of life (QoL) and ultimately survival. Ongoing research aims to determine the effectiveness and impact of exercise rehabilitation on reducing/managing the risk of CVD, alleviating physical function limitations, preventing disability and enhancing QoL. Current research also aims to elucidate the mechanisms via which exercise therapy may contribute to clinically relevant benefits.
Exercise and chronic kidney disease: current recommendations. [2022]Patients with chronic kidney disease (CKD) are inactive and have reduced physical functioning and performance. Aerobic exercise interventions have been shown to increase maximal oxygen consumption in selected patients. In addition, preliminary evidence, although mixed, suggests that aerobic exercise training can improve blood pressure control, lipid profiles and mental health in this population. A few larger studies are now available showing that aerobic training can also improve physical functioning and performance. The impact on survival or hospitalisation has not been determined. Resistance exercise training, although less studied, appears to increase muscle strength and size and may also improve functioning. There have been several reports of successful combined exercise interventions, but the designs have not allowed evaluation of the relative benefits of aerobic and resistance training on physical functioning. Despite the evidence that exercise is safe and beneficial in patients with CKD, dialysis patients remain inactive, and exercise assessment, counselling and training is not widely offered to patients with CKD. Studies of the barriers to patient participation in exercise and to provider assessment and recommendations are needed so that more widely generalisable interventions can be developed. However, in the interim, patients should be encouraged to participate in moderate physical activity to meet the US Surgeon General's recommendations. Patients who are weak can benefit from strength-training interventions. Resistance and aerobic exercise programmes should be initiated at relatively low intensity in patients with CKD and progressed as slowly as tolerated in order to avoid injury and discontinuation of exercise. For patients on haemodialysis, incorporation of exercise into the dialysis session may increase patient participation and tolerance of exercise.
The physical deterioration of dialysis patients-Ignored, ill-reported, and ill-treated. [2018]The progressive physical deterioration of dialysis patients is apparent to all who are involved in their care. Exercise can help stem this decline, yet exercise uptake in chronic and end-stage kidney disease is low. The involvement of exercise professionals has been shown to significantly increase patients' physical function and improve their quality of life. However, exercise professionals are scarce in renal programs, far less than dietetic and social work services. A review of 10 years of renal exercise publications in the physical therapy and rehabilitation literature found that only 0.4% (7 out of a total of 1763) of all published articles were focused on people with kidney disease. This compared with stroke (44%, n=883), arthritis/bone (29%, n=458), cancer (9%, n=168), respiratory (8%, n=106), cardiac (5%, n=82), and diabetes (3%, n=45). These results reflect the low emphasis placed on renal rehabilitation by the physical therapy professions and the low renal content in physical therapy tertiary education programs. This is likely to have an impact on the level of involvement of physical therapists in renal programs leading to lower physical function and poorer quality of life for renal patients.
Exercise in the end-stage renal disease population. [2022]Many of the known benefits of exercise in the general population are of particular relevance to the ESRD population. In addition, the poor physical functioning that is experienced by patients who are on dialysis is potentially addressable through exercise interventions. The study of exercise in the ESRD population dates back almost 30 yr, and numerous interventions, including aerobic training, resistance exercise training, and combined training programs, have reported beneficial effects. Recently, interventions during hemodialysis sessions have become more popular and have been shown to be safe. The risks of exercise in this population have not been rigorously studied, but there have been no reports of serious injury as a result of participation in an exercise training program. It is time that we incorporate exercise into the routine care of patients who are on dialysis, but identification of an optimal training regimen or regimens, according to patient characteristics or needs, is still needed to facilitate implementation of exercise programs.
Exercise training during hemodialysis in Brazil: A national survey. [2022]To evaluate the availability and characteristics of exercise training during hemodialysis in Brazil and to identify the reported barriers to exercise program implementation and maintenance. All dialysis units were assessed for eligibility using the database of the Brazilian Society of Nephrology. Each dialysis unit was contacted by telephone and the questions were administered. In dialysis units with exercise training, questions related to personnel involved, exercise components, and program delivery were included. Additionally, the barriers to exercise program implementation and maintenance were evaluated. This study included 261 dialysis units that responded to the survey. Forty-one dialysis units reported exercise training during hemodialysis in Brazil (prevalence of 15.7%). We identified 66 physiotherapists and 10 exercise physiologists in dialysis units with exercise training. Resistance training was the most common program component (92.7%). Hypotension (90.5%) and muscle cramps (85.7%) were the most common adverse events reported. In dialysis units with exercise training, poor patients' adherence to exercise was the most commonly reported barrier. The most prevalent barrier in dialysis units that tried or never tried to implement the exercise programs was a lack of resources. The number of dialysis units that have exercise training during hemodialysis in Brazil is low, and the most common program component is resistance training. A lack of resources was the most prevalent barrier in dialysis units that tried or never tried to implement the exercise programs.
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.
Exercise training in CKD: efficacy, adherence, and safety. [2022]Exercise training increasingly is recommended as an important part of the management of cardiovascular disease. However, few studies have evaluated the effectiveness of exercise training in patients with chronic kidney disease (CKD), and those that have included very selective populations.
Exercise as a therapeutic intervention in chronic kidney disease: are we nearly there yet? [2023]The opportunity to review the more recent evidence for prescribing exercise-based physical rehabilitation for people living with chronic kidney disease (CKD) is timely. There has been a recent global focus evaluating how physical activity interventions might improve health-related quality of life and outcomes for people living with chronic health conditions in a post-COVID era. There is finally a long overdue commitment from the kidney research and clinical community to deliver pragmatic interventions to help people living with CKD to be able to live well with their condition.
Implementing exercise: what do we know? Where do we go? [2022]Exercise capacity, physical functioning, and physical activity are all low in patients with CKD treated with dialysis. Although there is robust evidence that these patients benefit from regular exercise training and/or increasing physical activity, the nephrology community has not adopted recommendations and encouragement for physical activity as a part of the routine care plan. This article reviews what is known regarding the implementation of exercise and provides suggestions as to how exercise counseling might become a routine part of the care of patients with CKD.