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

Not Applicable

• Conditions: Renal Dialysis
• Interventions: Procedure: Intra-dialytic exercise

• Registration Number: NCT01674153
• Lead Sponsor: National University Hospital, Singapore

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-23
• Study First Submitted QC: 2012-08-27
• Study First Posted: 2012-08-28
• Status Verified: 2014-04
• Primary Completion: 2014-04
• Last Update Submitted: 2014-04-01
• Last Update Posted: 2014-04-03
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HD-Exercise-HDF	Intra-dialytic exercise	Prescribe intra-dialytic exercise of three bouts in 4 hours dialysis session.

Primary Outcome Measures

Name	Time	Method
Quantify toxin removal	6 months	Measure/estimate amount of toxin(s) removed and quantify corresponding physiological changes

Secondary Outcome Measures

Name	Time	Method
Compare exercise regimen with HDF	6 months	Compare amount of toxin removed for conventional hemodialysis (HD), HD with intra-dialytic exercise, and hemodiafiltration

Trial Locations

Locations (1)

Dialysis Center, National University of Singapore; 🇸🇬 Singapore, Singapore