Effects of Intradialytic Exercise as Assessed by Bioimpedance Analysis and Blood Volume Monitoring
Recruitment status was Recruiting
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.
|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|
- 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.
- 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.
|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)|
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.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01273753
|Contact: Michael Heung, MDfirstname.lastname@example.org|
|United States, Michigan|
|University of Michigan Health System||Recruiting|
|Ann Arbor, Michigan, United States, 48103|
|Contact: Michael Heung, MD 734-936-4890 email@example.com|
|Principal Investigator:||Michael Heung, MD||University of Michigan|