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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University of Michigan.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Renal Research Institute
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT01273753
First received: January 6, 2011
Last updated: January 7, 2011
Last verified: January 2011
  Purpose

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 Intervention
Kidney Failure, Chronic
Other: Intradialytic exercise

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Using Bioimpedance Analysis and Blood Volume Monitoring to Assess the Impact of Intradialytic Exercise

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Change in bioimpedance analysis trend during dialysis [ Time Frame: Baseline (no exercise) and 4 weeks (with exercise) ] [ Designated as safety issue: No ]
    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:
  • Blood volume monitoring [ Time Frame: Baseline (no exercise) and 4 weeks (with exercise) ] [ Designated as safety issue: No ]
    Blood volume monitoring will be done during dialysis to assess the impact of exercise on the slope of blood volume changes.


Estimated Enrollment: 20
Study Start Date: January 2011
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01273753

Contacts
Contact: Michael Heung, MD 734-936-4890 mheung@umich.edu

Locations
United States, Michigan
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48103
Contact: Michael Heung, MD    734-936-4890    mheung@umich.edu   
Sponsors and Collaborators
University of Michigan
Renal Research Institute
Investigators
Principal Investigator: Michael Heung, MD University of Michigan
  More Information

No publications provided

Responsible Party: Michael Heung / Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01273753     History of Changes
Other Study ID Numbers: Heung-BIA1
Study First Received: January 6, 2011
Last Updated: January 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
End-stage renal disease
Hemodialysis
Bioimpedance analysis
Blood volume monitoring

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 21, 2014