A Multi Protocol Investigation to Compare the Effects of Intra-dialytic Exercise on Physiological Changes and Toxin Removal in Maintenance Hemodialysis Patients
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Quantify toxin removal
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
HD-Exercise-HDF
Prescribe intra-dialytic exercise of three bouts in 4 hours dialysis session.
Intervention: Intra-dialytic exercise (Procedure)
Outcomes
Primary Outcomes
Quantify toxin removal
Time Frame: 6 months
Measure/estimate amount of toxin(s) removed and quantify corresponding physiological changes
Secondary Outcomes
- Compare exercise regimen with HDF(6 months)