Exercise Preconditioning for Cardioprotection During Hemodialysis
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Lawson Health Research Institute
No Placebo Group
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?The goal of this study is to determine what happens to the heart muscle contraction when people cycle before their hemodialysis treatment. Will pre-dialysis exercise protect the heart from a decrease in pumping of the heart muscle (called stunning) that can happen during hemodialysis. We will study whether pre-dialysis exercise decreases heart stunning, decreases the number and severity of symptoms commonly associated with hemodialysis, and other outcomes
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 Intradialytic Cycling, Intradialytic Exercise, Intradialytic Cycling Therapy, Exercise During Hemodialysis?
Research shows that exercise during hemodialysis, like cycling, can improve muscle strength, endurance, and overall physical function in patients with kidney disease. It also helps improve nutrition and hydration status, and may reduce heart-related issues during dialysis, enhancing quality of life and recovery time.
12345Is intradialytic exercise safe for humans?
Intradialytic exercise, such as cycling during hemodialysis, is generally considered safe for patients with end-stage kidney disease. Studies have shown it can improve physical condition and does not increase the risk of heart issues during dialysis.
12346How is the treatment Intradialytic Cycling different from other treatments for cardioprotection during hemodialysis?
Intradialytic Cycling is unique because it involves exercising on a stationary bike during hemodialysis sessions, which can improve heart health by stabilizing blood flow and reducing heart strain, unlike traditional treatments that do not incorporate exercise.
23478Eligibility Criteria
This trial is for individuals who are undergoing hemodialysis, a treatment for kidney failure. Participants should be willing to exercise before their dialysis sessions. Specific eligibility criteria are not provided, but typically include factors like age range, overall health status, and the absence of conditions that could interfere with the study or pose risks.Inclusion Criteria
I am 18 years old or older.
I have been on hemodialysis for at least 3 months.
Exclusion Criteria
I am over 79 years old.
I have had a heart attack or other heart issue in the last 3 months.
I do not have uncontrolled heart rhythm problems or chest pain.
I experience shortness of breath with little to no activity.
Participant Groups
The study is testing if cycling before hemodialysis can protect the heart from damage during treatment. It aims to see whether this 'preconditioning' exercise can prevent a decrease in heart muscle pumping ability and reduce symptoms related to hemodialysis.
2Treatment groups
Experimental Treatment
Group I: Randomization Order 2Experimental Treatment1 Intervention
Participants will be randomized into one of the two groups indicating the order in which they will receive the exercise intervention.
Randomization Order 2 will receive the exercise treatment on the first day of the fourth week of the study. The other three days without exercise will consist of standard dialysis sessions with study procedures.
Group II: Randomization Order 1Experimental Treatment1 Intervention
Participants will be randomized into one of the two groups indicating the order in which they will receive the exercise intervention.
Randomization Order 1 will receive the exercise treatment on the first day of the first week of the study. The other three days without exercise will consist of standard dialysis sessions with study procedures.
Intradialytic Cycling is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Intradialytic Cycling for:
- Improvement of physical function in hemodialysis patients
- Enhancement of cardiovascular health in patients undergoing hemodialysis
🇺🇸 Approved in United States as Intradialytic Cycling for:
- Reduction of hemodialysis-induced myocardial stunning
- Improvement of exercise capacity in adult hemodialysis patients
🇨🇦 Approved in Canada as Intradialytic Cycling for:
- Enhancement of physical function and quality of life in hemodialysis patients
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
London Health Sciences CentreLondon, Canada
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Who is running the clinical trial?
Lawson Health Research InstituteLead Sponsor
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph'sLead Sponsor
London Health Sciences Centre OR Lawson Research Institute of St. Joseph'sLead Sponsor
References
A Randomized Trial Examining the Impact of Timing of Intradialytic Cycling on Intradialytic Hypotension. [2023]Intradialytic cycling is often performed during the first half of hemodialysis because of concerns regarding increased frequency of intradialytic hypotension (IDH) late in hemodialysis. This increases exercise program resource needs and limits utility of intradialytic cycling to treat dialysis-related symptoms.
Spinning the legs and blood: should intradialytic exercise be routinely offered during maintenance haemodialysis? [2022]Patients with end-stage kidney disease on haemodialysis (HD) have an elevated risk of cardiovascular disease (CVD). These patients also experience high levels of physical deconditioning and programmes of rehabilitation have been tested in a variety of forms with variable success. It has been suggested that programmes of exercise rehabilitation have a role to play in improving the physical condition of patients on HD and in addressing the traditional and non-traditional risk factors that drive CVD for this population. Intradialytic exercise has often been suggested as a convenient way of delivering rehabilitation for patients on HD, as it makes use of otherwise dead time, but there are legitimate concerns about this group of at-risk patients undertaking exercise at a time when their myocardium is already vulnerable to the insults of demand ischaemia from the processes of dialysis and ultrafiltration. A study in this issue of Clinical Kidney Journal provides reassuring data, showing that cycling during dialysis potentially reduces evidence of demand ischaemia (episodes of myocardial stunning). Together with the safety and quality of life data, we expect from the multicentre PrEscription of Intra-Dialytic Exercise to Improve quAlity of Life in Patients With Chronic Kidney Disease study (the protocol for which is published concurrently), rehabilitation programmes that include intradialytic exercise are perhaps closer than ever for patients on HD.
Twelve-week intradialytic cycling exercise improves physical functional performance with gain in muscle strength and endurance: a randomized controlled trial. [2022]To evaluate the effect of intradialytic cycling exercise on physical functional performance with gain in muscle strength and endurance in end-stage renal disease patients with haemodialysis.
Nutrition and hydration status improve with exercise training using stationary cycling during hemodialysis (HD) in patients with end-stage renal disease (ESRD). [2013]Patients with end-stage renal disease (ESRD) undergoing hemodialysis and peritoneal dialysis are functionally limited as a consequence of their physical, emotional, and social problems. Exercise intolerance is a major problem in chronic renal failure. Stationary cycle training during hemodialysis is recommended as safe, effective, and practical in ESRD patients treated on hemodialysis. The aim of the present study was to evaluate the effect of cycling exercises in 10 HD patients during 6-month period (including each of dialysis sessions) on nutrition, dialysis adequacy, and fluid parameters as measured by biochemical, and bioimpedance parameters. A significant increase in serum albumin concentration, Kt/V, and nPCR, and decrease in serum CRP have been observed after 6 months of regular stationary cycling during hemodialysis. Relative changes (pre-post HD) in extracellular water compartment and ECW/TBW ratio have significantly increased after 6 months of observation period.
Evaluating the effect of intradialytic cycling exercise on quality of life and recovery time in hemodialysis patients: A randomized clinical trial. [2023]The aim of this study was to assess the effect of intradialytic cycling exercise on quality of life (QOL) and recovery time in patients who underwent hemodialysis.
Efficacy and safety of intradialytic exercise in haemodialysis patients: a systematic review and meta-analysis. [2020]To assess the efficacy and safety of intradialytic exercise for haemodialysis patients.
Hemodynamic Instability during Dialysis: The Potential Role of Intradialytic Exercise. [2018]Acute haemodynamic instability is a natural consequence of disordered cardiovascular physiology during haemodialysis (HD). Prevalence of intradialytic hypotension (IDH) can be as high as 20-30%, contributing to subclinical, transient myocardial ischemia. In the long term, this results in progressive, maladaptive cardiac remodeling and impairment of left ventricular function. This is thought to be a major contributor to increased cardiovascular mortality in end stage renal disease (ESRD). Medical strategies to acutely attenuate haemodynamic instability during HD are suboptimal. Whilst a programme of intradialytic exercise training appears to facilitate numerous chronic adaptations, little is known of the acute physiological response to this type of exercise. In particular, the potential for intradialytic exercise to acutely stabilise cardiovascular hemodynamics, thus preventing IDH and myocardial ischemia, has not been explored. This narrative review aims to summarise the characteristics and causes of acute haemodynamic instability during HD, with an overview of current medical therapies to treat IDH. Moreover, we discuss the acute physiological response to intradialytic exercise with a view to determining the potential for this nonmedical intervention to stabilise cardiovascular haemodynamics during HD, improve coronary perfusion, and reduce cardiovascular morbidity and mortality in ESRD.
Effects of exercise training during hemodialysis. [2018]Fourteen maintenance hemodialysis patients volunteered to participate in a 6-month program of exercise training. The exercise was performed on a stationary bicycle during the hemodialysis treatment. Six maintenance hemodialysis patients served as control without exercise training. Exercising patients participated in 91% of all possible exercise sessions. The exercise group showed a significant (23%) increase in maximal oxygen consumption over the 6 months. No change in exercise capacity resulted in the control group. Five of eight hypertensive patients in the exercise group decreased or discontinued antihypertensive medications. No changes occurred in hematocrit or lipid profiles in either group. We conclude that exercise training during the hemodialysis treatment is technically feasible and safe for appropriately screened patients and will increase exercise capacity, and in some patients improve blood pressure control. Exercise during dialysis also improves compliance to regular exercise and facilitates supervised exercise sessions, which are desirable in this patient group.