Enhancing Dialysis Adequacy: Effects of Intradialytic Exercise

Study Overview
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Brief Summary
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The purpose of this study is to investigate whether intradialytic exercise increases removal of waste products from blood, in comparison to the traditional prescription of increasing dialysis duration.

Detailed Description
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For patients with severe chronic kidney disease, regular dialysis to remove toxins and waste products from the blood is essential to maintain life. The adequacy of dialysis is quantified by the removal of these toxic solutes and is an important parameter in the assessment of the therapy. Previous efforts to enhance urea clearance have centered around factors such as increasing dialysis dose by increasing dialysis time or carrying out more frequent dialysis sessions. However this concept is confronted with the barriers of patient compliance and cost implications. Many patients are resilient to increasing their dialysis time, presenting a major challenge for enhancing the efficacy of dialysis therapy. Therefore, alternative methods of improving dialysis adequacy, with interventions aimed at enhancing solute clearance, are highly warranted. One such intervention could be exercising during haemodialysis (HD). 85% of the body is comprised of lean tissue, of which 73% is water. As many toxic solutes are water based, large amounts will be stored in the muscle. When sitting at rest during HD the blood flow to the muscles is four times less compared to the major organs. Additionally, the HD process causes blood vessels to constrict, further restricting blood flow to the muscle. Consequently there is insufficient blood flow to remove the toxins stored in the muscle. By exercising during dialysis, blood flow to the muscle is increased to sustain the demand for oxygen and energy, thereby allowing toxic solutes to be removed and cleared through the dialysis machine. Therefore the aim of this study is to implement an efficient exercise intervention during dialysis and determine its effects on dialysis adequacy in comparison to the traditional prescription of increased dialysis time. In particular, the study aims to explore the acute effects of exercise during dialysis on the removal of several established uremic toxins.

Official Title
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Intradialytic Exercise for Enhanced Dialysis Adequacy and Solute Removal in Chronic Kidney Disease Patients: A Randomised Controlled Trial.

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Other: Exercise
* Other: Extra time


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stage 5 Chronic Kidney Disease Receiving maintenance haemodialysis for > 3 months Exclusion Criteria: Unable to give consent Present with contraindications to take part in exercise Haemoglobin <11 g/dL Access recirculation Chronic persistent hypotension with pre dialysis systolic blood pressures <100mgHg. Episodic treatment induced hypotension with frequent drops in intradialytic systolic blood pressure >30mmgHg Unstable medical condition Currently taking medication affecting urea or creatinine generation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Routine haemodialysis sessions as per usual | |
| Experimental: Intradialytic exercise<br>One hour of exercise completed during haemodialysis. | Other: Exercise<br>* Exercise During Dialysis Patients will be asked to carry out cycling exercise for 60 minutes during the third quarter of their routine haemodialysis session. Exercise can be carried out in ten minute bouts with several minutes rest between bouts.<br>|
| Active Comparator: Extra time<br>30 minutes extra dialysis time. | Other: Extra time<br>* An extra 30 minutes will be added to the currently prescribed treatment time of each patient.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urea clearance | The primary outcome is urea clearance which will be measured by continuously sampling waste dialysate from an entire dialysis session. | One dialysis session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urea clearance | Urea clearance which will be measured by continuously sampling UV absorbance of waste dialysate during an entire dialysis session. | One dialysis session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dialysis adequacy, Urea clearance, Phosphate clearance, Beta 2 microglobulin clearance, Intradialytic exercise, Haemodialysis patients