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

Primary Purpose

Kidney Failure, Chronic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intradialytic exercise
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Kidney Failure, Chronic focused on measuring End-stage renal disease, Hemodialysis, Bioimpedance analysis, Blood volume monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Michigan Health System

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Exercise

Arm Description

After baseline measurements, all subjects will undergo a phase involving intradialytic exercise. Subjects will serve as their own controls.

Outcomes

Primary Outcome Measures

Change in bioimpedance analysis trend during dialysis
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
Blood volume monitoring will be done during dialysis to assess the impact of exercise on the slope of blood volume changes.

Full Information

First Posted
January 6, 2011
Last Updated
December 1, 2014
Sponsor
University of Michigan
Collaborators
Renal Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01273753
Brief Title
Effects of Intradialytic Exercise as Assessed by Bioimpedance Analysis and Blood Volume Monitoring
Official Title
Using Bioimpedance Analysis and Blood Volume Monitoring to Assess the Impact of Intradialytic Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Renal Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic
Keywords
End-stage renal disease, Hemodialysis, Bioimpedance analysis, Blood volume monitoring

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Active Comparator
Arm Description
After baseline measurements, all subjects will undergo a phase involving intradialytic exercise. Subjects will serve as their own controls.
Intervention Type
Other
Intervention Name(s)
Intradialytic exercise
Intervention Description
Patients will exercise using a stationary foot pedal cycle for 20 minutes at the beginning of hemodialysis.
Primary Outcome Measure Information:
Title
Change in bioimpedance analysis trend during dialysis
Description
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.
Time Frame
Baseline (no exercise) and 4 weeks (with exercise)
Secondary Outcome Measure Information:
Title
Blood volume monitoring
Description
Blood volume monitoring will be done during dialysis to assess the impact of exercise on the slope of blood volume changes.
Time Frame
Baseline (no exercise) and 4 weeks (with exercise)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults aged 18yrs and older End-stage renal disease on thrice weekly maintenance hemodialysis for at least 3 months Stable dry weight for the preceding month Stable dialysis prescription for the preceding month Average interdialytic weight gain at least 1kg but less than 4% of total body weight. Exclusion Criteria: Patients receiving dialysis for acute renal failure Hospitalization >1 day in the preceding month Inability to complete exercise regimen or medical contraindication to exercise regimen Patients in whom a dry weight is yet to be established History of non-compliance with dialysis therapy (defined as > 3 missed treatments in a month) Inability to remain in horizontal position for duration of a dialysis session. Amputation of a limb other than fingers or toes. Pace maker, defibrillator, implantable pump, artificial joint, pins, plates or other types of metal objects in the body (other than dental fillings). Coronary stents or metal suture material in the heart.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Heung, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48103
Country
United States

12. IPD Sharing Statement

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

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