Investigating the Effects of Exercise on Physiological Changes and Toxin Removal in Hemodialysis Patients

Study Overview
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Brief Summary
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Hemodialysis is a life-saving treatment for end stage renal disease patients. The chief aims of hemodialysis are solute and fluid removal. Solute removal is associated with outcome of dialysis patients. Intra-dialytic exercise has been found to improve the toxin removal and it is suggested that exercise increases the cardiac output, thus increases the blood flow to lower extremities. This leads to increased toxin removal from low blood flow regions. On the other hand, exercise can possibly dilate the vasculature and decrease the compartmental resistance. In this study, the investigators aim to investigate the exercise induced physiological changes which enhances the toxin removal. This information combined with patient specific mathematical models will encourage clinicians to opt for Optimal intra-dialytic exercise protocol. On the other hand, Hemodiafiltration is widely accepted renal replacement therapy for improved toxin removal. Hence, we intend to compare the toxin removal outcome for standalone Hemodiafiltration and intra-dialytic exercise in conventional hemodialysis.

Official Title
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A Multi Protocol Investigation to Compare the Effects of Intra-dialytic Exercise on Physiological Changes and Toxin Removal in Maintenance Hemodialysis Patients

Conditions
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Renal Dialysis

Intervention / Treatment
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* Procedure: Intra-dialytic exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients male or female (Age > 21 years) Minimum dialysis vintage of 6 months Stable on hemodialysis Minimum Hemoglobin level of 10 g/dL Blood access capable of delivering the blood flow rate greater than 250 mL/min Preserved left ventricular ejection fraction (>50%) on prior imaging study Able to complete a 6min-walk-test without abnormal physiological response, excessive fatigue, or musculoskeletal discomfort Exclusion Criteria: History of recurring or persistent hypotension in past 3 months Pregnant woman Severely Hypertensive patients (SBP > 180 mmHg and/or DBP > 115 mmHg) History of recent myocardial infarction or unstable angina (within past 6 months) Significant valvular disease, i.e. severe aortic stenosis and moderate-severe mitral regurgitation. Patients with end stage organ disease e.g. COPD, recent or debilitating CVA Patient with recent stroke (within past 6 months) Anemic patients History of known arrhythmia Participation in another clinical intervention trial Moderate to severe osteoarthritis of knee(s) Unable to consent

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HD-Exercise-HDF<br>Prescribe intra-dialytic exercise of three bouts in 4 hours dialysis session. | Procedure: Intra-dialytic exercise<br>* Perform intra-dialytic exercise of three bouts in 4 hours dialysis session. Each patient will perform exercise on Monark 881E rehab trainer (widely used in routine dialysis settings). The exercise intensity will be prescribed based on achievement of 50% of maximum heart rate for each recruited subject.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantify toxin removal | Measure/estimate amount of toxin(s) removed and quantify corresponding physiological changes | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare exercise regimen with HDF | Compare amount of toxin removed for conventional hemodialysis (HD), HD with intra-dialytic exercise, and hemodiafiltration | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intra-dialytic exercise, Toxin removal, Hemodiafiltration, Inter-compartmental resistance, Cardiac output