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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01674153
Recruitment Status : Unknown
Verified April 2014 by National University Hospital, Singapore.
Recruitment status was:  Recruiting
First Posted : August 28, 2012
Last Update Posted : April 3, 2014
National University, Singapore
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Renal Dialysis Procedure: Intra-dialytic exercise

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Multi Protocol Investigation to Compare the Effects of Intra-dialytic Exercise on Physiological Changes and Toxin Removal in Maintenance Hemodialysis Patients
Study Start Date : August 2012
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: HD-Exercise-HDF
Prescribe intra-dialytic exercise of three bouts in 4 hours dialysis session.
Procedure: Intra-dialytic exercise
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.

Primary Outcome Measures :
  1. Quantify toxin removal [ Time Frame: 6 months ]
    Measure/estimate amount of toxin(s) removed and quantify corresponding physiological changes

Secondary Outcome Measures :
  1. Compare exercise regimen with HDF [ Time Frame: 6 months ]
    Compare amount of toxin removed for conventional hemodialysis (HD), HD with intra-dialytic exercise, and hemodiafiltration

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01674153

Contact: Titus Lau, MD +65 6772 4388 ext 4388
Contact: Vaibhav Maheshwari, B.Tech. +65 9354 1493

Dialysis Center, National University of Singapore Recruiting
Singapore, Singapore, 119074
Contact: Titus Lau, MD    +65 6772 4388   
Principal Investigator: Titus Lau, MD         
Sponsors and Collaborators
National University Hospital, Singapore
National University, Singapore
Principal Investigator: Titus Lau, MD National University Hospital, Singapore

Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: National University Hospital, Singapore Identifier: NCT01674153     History of Changes
Other Study ID Numbers: DSRB - 2011/01942
NKFRC/2011/01/06 ( Other Grant/Funding Number: NKFRC/2011/01/06 )
First Posted: August 28, 2012    Key Record Dates
Last Update Posted: April 3, 2014
Last Verified: April 2014

Keywords provided by National University Hospital, Singapore:
Intra-dialytic exercise
Toxin removal
Inter-compartmental resistance
Cardiac output