Exercise for Chronic Kidney Disease
Palo Alto (17 mi)Overseen byJeanie Park, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Emory University
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.
What safety data exists for exercise in chronic kidney disease treatment?Exercise interventions in chronic kidney disease (CKD) and end-stage renal disease (ESRD) populations have been studied for nearly 30 years, showing beneficial effects without reports of serious injury. Exercise during hemodialysis is considered safe, though common adverse events include hypotension and muscle cramps. In kidney transplant recipients, exercise is also deemed safe and improves quality of life and exercise capacity. Despite these findings, exercise programs are not widely implemented, and more research is needed to determine optimal regimens and long-term effects.127910
Is exercise training a promising treatment for chronic kidney disease?Yes, exercise training is a promising treatment for chronic kidney disease. It can improve physical function, quality of life, and may help manage risks like cardiovascular disease. Encouraging regular exercise can help patients live better with their condition.134511
What data supports the idea that Exercise for Chronic Kidney Disease is an effective treatment?The available research shows that exercise can help people with chronic kidney disease (CKD) by improving their physical function and quality of life. Studies have found that exercise can increase physical fitness and help manage health issues like blood pressure and mental health. Although exercise is not yet a standard part of kidney care, it has been shown to be safe and beneficial. Compared to other treatments, exercise can specifically help with physical strength and endurance, which are important for overall health and well-being in CKD patients.146812
Do I have to stop taking my current medications for the trial?The trial does not specify if you must stop all current medications, but you cannot participate if you are using certain medications like central α-agonists, immunosuppressive medications, or if you have a contraindication to temporary withdrawal of α- and β-blockers.
Eligibility 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.
My kidney function is stable and my blood's bicarbonate level is within the normal range.
I have high blood pressure.
Exclusion Criteria
My BMI is over 40.
I am currently taking medications that suppress my immune system.
My heart pumps less blood than normal.
I have nerve damage due to diabetes.
I am currently taking bicarbonate.
I have symptoms of heart failure.
I cannot stop taking my α- and β-blocker medications.
My blood pressure is not higher than 170/100 mm Hg.
My kidney function is severely reduced.
I have peripheral arterial disease.
I have heart problems that show up on tests or in my medical history.
I am currently taking medication like clonidine.
Treatment Details
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
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.
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.
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.
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 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.
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.
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.
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.
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 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 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.
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.