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Effects of Intradialytic Exercise as Assessed by Bioimpedance Analysis and Blood Volume Monitoring

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: NCT01273753
Recruitment Status : Completed
First Posted : January 10, 2011
Last Update Posted : December 2, 2014
Renal Research Institute
Information provided by (Responsible Party):
Michael Heung, University of Michigan

Brief Summary:
The purpose of this study is to examine the impact of exercise during dialysis using objective measures of fluid status determination, specifically bioimpedance analysis (BIA) and blood volume monitoring (BVM). We hypothesize that exercise during dialysis will be associated with more stable blood pressures and that this will be reflected in different output from BIA and BVM monitoring.

Condition or disease Intervention/treatment Phase
Kidney Failure, Chronic Other: Intradialytic exercise Not Applicable

Detailed Description:

Achieving dry weight (DW) is essential for the optimal health of dialysis patients. Despite being one of the most basic and important factors in the management of hemodialysis patients, there are many obstacles to achieving DW. One problem underlying optimal fluid status management lies in the clinical assessment used to determine DW. The current standard is clinical judgment which is often reactive (ie. setting a weight below which the patient develops hypotension or cramping) instead of goal directed (ie. trying to achieve defined target measures). Moreover, DW is a dynamic parameter that changes in patients over time, and ongoing assessment remains reactive to changes in clinical status instead of proactively based on monitoring of validated measures. A primary impediment to achieving DW is the relatively short time during dialysis limiting vascular refilling and leading to complications of hypotension and other adverse sequelae of relatively rapid volume removal. The evaluation of interventions aimed at improving symptoms and preventing complications will be scientifically strengthened by objective assessment of the patient's volume. Fortunately two objective clinically validated tools to assess volume status have emerged: bioimpedance (BIA) which allows assessment of the patient's hydration status and blood volume monitoring (BVM) which allows direct measure of the rate of vascular refilling during dialysis. These will be essential in understanding the impact of therapeutic interventions directed at improving achievement of DW.

The next important consideration is selecting an intervention that shows promise in assisting patients in achieving DW. While many interventions deserve careful analysis we select exercise because of the additional cardiovascular benefits of exercise, and it fits into our outpatient program as part of achieving our overall outpatient wellness objectives. To this end we propose the following specific aim:

Specific Aim: Systematically evaluate the effects of exercise on hemodynamic stability and achievement of dry weight by testing the following hypotheses.

Hypothesis 1: Exercise bike riding during dialysis improves vascular refilling as determined by BVM.

Hypothesis 2: Exercise bike riding during dialysis improves (leads to a reduction in) tissue hydration status as determined by BIA.

Hypothesis 3: Improved intra-dialytic blood pressure stability is directly related to improved vascular refilling as assessed by BVM, which is in turn related to improved (reduced) tissue hydration as assessed by BIA.

Hypothesis 4: Intravascular refilling (assessed by BVM) is directly related to reduction in tissue hydration (assess by BIA).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Using Bioimpedance Analysis and Blood Volume Monitoring to Assess the Impact of Intradialytic Exercise
Study Start Date : January 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Exercise
After baseline measurements, all subjects will undergo a phase involving intradialytic exercise. Subjects will serve as their own controls.
Other: Intradialytic exercise
Patients will exercise using a stationary foot pedal cycle for 20 minutes at the beginning of hemodialysis.

Primary Outcome Measures :
  1. Change in bioimpedance analysis trend during dialysis [ Time Frame: Baseline (no exercise) and 4 weeks (with exercise) ]
    The investigators will assess the impact of intradialytic exercise on body composition and fluid removal by comparing BIA measurements and trends between dialysis treatments. The baseline measurement will occur during standard usual dialysis, while the 4 week meaurement will occur during dialysis with exercise.

Secondary Outcome Measures :
  1. Blood volume monitoring [ Time Frame: Baseline (no exercise) and 4 weeks (with exercise) ]
    Blood volume monitoring will be done during dialysis to assess the impact of exercise on the slope of blood volume changes.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Adults aged 18yrs and older
  2. End-stage renal disease on thrice weekly maintenance hemodialysis for at least 3 months
  3. Stable dry weight for the preceding month
  4. Stable dialysis prescription for the preceding month
  5. Average interdialytic weight gain at least 1kg but less than 4% of total body weight.

Exclusion Criteria:

  1. Patients receiving dialysis for acute renal failure
  2. Hospitalization >1 day in the preceding month
  3. Inability to complete exercise regimen or medical contraindication to exercise regimen
  4. Patients in whom a dry weight is yet to be established
  5. History of non-compliance with dialysis therapy (defined as > 3 missed treatments in a month)
  6. Inability to remain in horizontal position for duration of a dialysis session.
  7. Amputation of a limb other than fingers or toes.
  8. Pace maker, defibrillator, implantable pump, artificial joint, pins, plates or other types of metal objects in the body (other than dental fillings).
  9. Coronary stents or metal suture material in the heart.

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): NCT01273753

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United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48103
Sponsors and Collaborators
University of Michigan
Renal Research Institute
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Principal Investigator: Michael Heung, MD University of Michigan
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Responsible Party: Michael Heung, Principal Investigator, University of Michigan Identifier: NCT01273753    
Other Study ID Numbers: Heung-BIA1
First Posted: January 10, 2011    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: December 2014
Keywords provided by Michael Heung, University of Michigan:
End-stage renal disease
Bioimpedance analysis
Blood volume monitoring
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic