Effect of Intradialytic Electrical Muscle Stimulation and Passive Leg Mobilisation on Blood Pressure and Dialysis Efficacy
Primary Purpose
Hypotension
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
transcutaneous muscle stimulation, treadmill
Sponsored by
About this trial
This is an interventional treatment trial for Hypotension focused on measuring Dialysis associated hypotension, Urea removal
Eligibility Criteria
Inclusion Criteria: Dialysis patients able to put legs on a treadmill Exclusion Criteria: Dialysis duration shorter than 3 months
Sites / Locations
- Department of Nephrology and Hypertension, University Hospital of Berne
Outcomes
Primary Outcome Measures
Blood pressure
Urea removal
Secondary Outcome Measures
Number of hypotensive episodes on dialysis
Full Information
NCT ID
NCT00328289
First Posted
May 18, 2006
Last Updated
January 12, 2011
Sponsor
Insel Gruppe AG, University Hospital Bern
1. Study Identification
Unique Protocol Identification Number
NCT00328289
Brief Title
Effect of Intradialytic Electrical Muscle Stimulation and Passive Leg Mobilisation on Blood Pressure and Dialysis Efficacy
Official Title
Effect of Intradialytic Electrical Muscle Stimulation and Passive Leg Mobilisation on Blood Pressure and Dialysis Efficacy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
4. Oversight
5. Study Description
Brief Summary
Hypothesis: Intradialytic blood pressure and dialysis efficacy (in terms of urea removal) improve under electrical muscle stimulation or passive leg movement on a treadmill.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension
Keywords
Dialysis associated hypotension, Urea removal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
transcutaneous muscle stimulation, treadmill
Primary Outcome Measure Information:
Title
Blood pressure
Title
Urea removal
Secondary Outcome Measure Information:
Title
Number of hypotensive episodes on dialysis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Dialysis patients able to put legs on a treadmill
Exclusion Criteria:
Dialysis duration shorter than 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominik Uehlinger, Prof
Organizational Affiliation
Department of Nephrology and Hypertension, University Hospital of Berne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nephrology and Hypertension, University Hospital of Berne
City
Berne
ZIP/Postal Code
3010
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Effect of Intradialytic Electrical Muscle Stimulation and Passive Leg Mobilisation on Blood Pressure and Dialysis Efficacy
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