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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
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypotension focused on measuring Dialysis associated hypotension, Urea removal

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
May 18, 2006
Last Updated
January 12, 2011
Sponsor
Insel Gruppe AG, University Hospital Bern
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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

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Effect of Intradialytic Electrical Muscle Stimulation and Passive Leg Mobilisation on Blood Pressure and Dialysis Efficacy

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