Combination Exercise for Chronic Kidney Disease
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: VA Office of Research and Development
Disqualifiers: Acute renal failure, Non-ambulatory, Uncontrolled cardiovascular, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?The VA health care system uses a health promotion-focused model which aims to provide longitudinal care through a patient-aligned care team for Veterans with chronic kidney disease. Since the largest subpopulation of Veterans with chronic kidney disease is comprised of those not requiring dialysis, neuromuscular screening assessments may provide valuable information regarding an individual overall health status and potential for future complications. Furthermore, identifying at risk individuals early in the disease process will allow for the prescription of timely interventions. Exercise strategies such as combination exercise, which uses flywheel resistance plus aerobic exercise, may provide a valuable treatment option for combating neuromuscular dysfunction and functional decline in patients with chronic kidney disease.
Do I have to stop taking my current medications for the trial?
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 Combination Exercise for Chronic Kidney Disease?
Research shows that combining aerobic and resistance exercises can significantly improve muscle strength, muscle volume, and exercise capacity in patients with chronic kidney disease, more so than aerobic exercise alone.
12345Is combination exercise safe for people with chronic kidney disease?
Research shows that combination exercise, which includes both resistance and aerobic activities, is generally safe for people with chronic kidney disease. Studies found no significant health worsening in participants, and no complications were reported during exercise protocols.
23678How is the Combination Exercise treatment different from other treatments for chronic kidney disease?
Combination Exercise, which includes both aerobic and resistance exercises, is unique because it provides greater improvements in muscle strength and volume compared to aerobic exercise alone, making it particularly beneficial for patients with chronic kidney disease.
123910Eligibility Criteria
This trial is for English-speaking Veterans over 50 with chronic kidney disease stages 3 & 4 who can walk (with or without help). It's not for those with acute kidney issues in the past year, non-ambulatory individuals, people planning to move from the DC area within a year, or those with uncontrolled heart or musculoskeletal conditions.Inclusion Criteria
All participants must be able to speak and read English, and demonstrate orientation to person, place, and time
I can walk and have no signs of kidney disease in the past year.
I am 50 or older, can walk (with or without help), and have stage 3 or 4 CKD not on dialysis.
Exclusion Criteria
I do not have any uncontrolled heart or muscle diseases that make it unsafe for me to join the study.
I was diagnosed with acute kidney failure in the last year.
Individuals with plans to relocate from the DC metro area within one year will not be eligible for the intervention portion of the study
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo 12 weeks of flywheel resistance plus aerobic exercise training to improve fatigability status, neuromuscular capacity, and physical function
12 weeks
Follow-up
Participants are monitored for changes in fatigability, neuromuscular capacity, and physical function
4 weeks
Participant Groups
The study tests combination exercise (flywheel resistance plus aerobic) on fatigue in Veterans with chronic kidney disease. The goal is to see if this exercise can improve muscle function and overall health compared to a control group without kidney disease.
2Treatment groups
Experimental Treatment
Active Control
Group I: Combination ExerciseExperimental Treatment1 Intervention
Flywheel resistance exercise plus aerobic exercise
Group II: Standard-of-careActive Control1 Intervention
Participants will maintain standard-of-care and current activity levels during the course of the study.
Combination Exercise is already approved in United States for the following indications:
🇺🇸 Approved in United States as Combination Exercise Therapy for:
- Neuromuscular dysfunction in chronic kidney disease
- Functional decline in chronic kidney disease
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Washington DC VA Medical Center, Washington, DCWashington, United States
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Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
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.
Twelve-week combined resistance and aerobic training confers greater benefits than aerobic training alone in nondialysis CKD. [2022]There is a growing consensus that patients with chronic kidney disease (CKD) should engage in regular exercise, but there is a lack of formal guidelines. In this report, we determined whether combined aerobic and resistance exercise would elicit superior physiological gains, in particular muscular strength, compared with aerobic training alone in nondialysis CKD. Nondialysis patients with CKD stages 3b-5 were randomly allocated to aerobic exercise {AE, n = 21; 9 men; median age 63 [interquartile range (IQR) 58-71] yr; median estimated glomerular filtration rate (eGFR) 24 (IQR 20-30) ml·min-1·1.73 m-2} or combined exercise [CE, n = 20, 9 men, median age 63 (IQR 51-69) yr, median eGFR 27 (IQR 22-32) ml·min-1·1.73 m-2], preceded by a 6-wk run-in control period. Patients then underwent 12 wk of supervised AE (treadmill, rowing, or cycling exercise) or CE training (as AE plus leg extension and leg press exercise) performed three times per week. Outcome assessments of knee extensor muscle strength, quadriceps muscle volume, exercise capacity, and central hemodynamics were performed at baseline, following the 6-wk control period, and at the end of the intervention. AE and CE resulted in significant increases in knee extensor strength of 16 ± 19% (mean ± SD; P = 0.001) and 48 ± 37% ( P < 0.001), respectively, which were greater after CE ( P = 0.02). AE and CE resulted in 5 ± 7% ( P = 0.04) and 9 ± 7% ( P < 0.001) increases in quadriceps volume, respectively ( P < 0.001), which were greater after CE ( P = 0.01). Both AE and CE increased distance walked in the incremental shuttle walk test [28 ± 44 m ( P = 0.01) and 32 ± 45 m ( P = 0.01), respectively]. In nondialysis CKD, the addition of resistance exercise to aerobic exercise confers greater increases in muscle mass and strength than aerobic exercise alone.
Combined resistance and aerobic exercise is better than resistance training alone to improve functional performance of haemodialysis patients--results of a randomized controlled trial. [2022]This study aims to compare the effects of combined resistance and aerobic exercise with a resistance programme alone on functional performance among haemodialysis patients.
Physical Activity and Exercise for Cardiorespiratory Health and Fitness in Chronic Kidney Disease. [2023]Chronic kidney disease (CKD) is associated with an increased risk for cardiovascular disease (CVD), major adverse CVD events, and cardiovascular mortality. Low levels of physical activity and reduced cardiorespiratory fitness further compound the health consequences in this patient population. Aerobic exercise alone and the combination of aerobic and resistance exercise have beneficial effects for improving aerobic capacity while resistance exercise alone improves strength and skeletal muscle health. Given the prevalence of CVD in CKD patients and limited treatment options targeting traditional and non-traditional CVD risk factors in this population, the incoroporation of physical activity and exercise into the care of CKD seems critical for improving patient outcomes. Therefore, the purpose of this narrative review is to discuss the evidence of physical activity and exercise in CKD patients and the effects on cardiovascular outcomes and fitness.
Mortality and morbidity following exercise-based renal rehabilitation in patients with chronic kidney disease: the effect of programme completion and change in exercise capacity. [2021]Twelve weeks of renal rehabilitation (RR) have been shown to improve exercise capacity in patients with chronic kidney disease (CKD); however, survival following RR has not been examined.
Preliminary Study of the Effects of Eccentric-Overload Resistance Exercise on Physical Function and Torque Capacity in Chronic Kidney Disease. [2023]The purpose of this preliminary study was to describe changes in physical function and torque capacity in adults with chronic kidney disease (CKD) in response to a novel progressive eccentric-overload resistance exercise (ERE) regime. Participants included men (n = 4) diagnosed with CKD according to estimated glomerular filtration rate (eGFR) between 59 and 15 mL/kg/1.73 m2 and not requiring dialysis. Physical function was determined by the Short Physical Performance Battery (SPPB), five repetitions of a sit-to-stand (STS) task, and timed-up and go (TUG). Knee extensor strength was assessed using both isometric and isokinetic contractions and performance fatigability indexes were calculated during a 30-s maximal isometric test and a 30-contraction isokinetic test at 180°/second. None of the patients exhibited significant worsening in their health status after training. Participants demonstrated improvements in several measures of physical function and torque capacity following 24 sessions of ERE. Following training, performance fatigability remained relatively stable despite the increases in torque capacity, indicating the potential for greater fatigue resistance. These findings provide initial evidence for ERE as a potential treatment option to combat declines in physical function and neuromuscular impairments in people with CKD. Future research is required to determine optimal progression strategies for maximizing specific neuromuscular and functional outcomes when using ERE in this patient population.
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.
Effects of long-term aerobic training and detraining on functional capacity and quality of life in hemodialysis patients: A pilot study. [2020]Although previous studies have shown the benefits of exercise training in hemodialysis patients, little is known about the effects of long-term of exercise program on these patients. We investigated the effects and the safety of long-term aerobic training and the effects of detraining on functional capacity and quality of life in hemodialysis patients. Ten patients were allocated to two groups: training and detraining. The training group completed at least 30 months of aerobic training, and the detraining group completed at least 20 months and then discontinued the training for at least 10 months. The outcomes were analyzed at baseline, after 3 months of aerobic training and at the 30-month follow-up. The training and detraining groups performed 37 (5.5) and 24 (3.0) months of aerobic training, respectively. The detraining group discontinued the training for 11.0 (2.0) months. After 3 months of aerobic training, six-minute walking test distance increased significantly in both groups (training group = 569 (287.8) vs 635.5 (277.0) m, p = 0.04; detraining group = 454.5 (72.3) vs 515.0 (91.8) m, p = 0.04). There was no significant difference in the six-minute walking test distance in the training group (576.5 (182.5), p > 0.05) and a significant decrease (436.2 (89.6) m, p = 0.04) in the detraining group at the follow-up compared to the third month of aerobic training. No significant difference was observed in quality of life during the study. No complications were found during the protocol of the exercise. These results suggest that long-term aerobic training is safe and can maintain functional capacity in hemodialysis patients. In contrast, detraining can result in loss of functional capacity in these patients.
Effects of combined aerobic and resistance exercise on renal function in adult patients with chronic kidney disease: a systematic review and meta-analysis. [2022]Combined aerobic and resistance exercise (CARE) is beneficial for improving renal function. To confirm this, we conducted a meta-analysis to evaluate the effects of CARE on renal function in adult patients with chronic kidney disease (CKD).
Combined training is the most effective training modality to improve aerobic capacity and blood pressure control in people requiring haemodialysis for end-stage renal disease: systematic review and network meta-analysis. [2019]Do aerobic, resistance and combined exercise training improve aerobic capacity, arterial blood pressure and haemodialysis efficiency in people requiring haemodialysis for end-stage renal disease? Is one exercise training modality better than the others for improving these outcomes?