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Clinical Trials/NCT01674153
NCT01674153
Unknown
Not Applicable

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

National University Hospital, Singapore1 site in 1 country15 target enrollmentAugust 2012
ConditionsRenal Dialysis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Renal Dialysis
Sponsor
National University Hospital, Singapore
Enrollment
15
Locations
1
Primary Endpoint
Quantify toxin removal
Last Updated
12 years ago

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.

Registry
clinicaltrials.gov
Start Date
August 2012
End Date
July 2014
Last Updated
12 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

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)

Study Sites (1)

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