The Effects of Plantar Stimulation on Hypotension, Treatment Efficacy and Quality of Life With Adults on Hemodialysis

This study is enrolling participants by invitation only.

Sponsor:

Information provided by:

Binghamton University

ClinicalTrials.gov Identifier:

NCT00822653

First received: January 13, 2009

Last updated: NA

Last verified: January 2009

History: No changes posted

Tracking Information
First Received Date ^ICMJE	January 13, 2009
Last Updated Date	January 13, 2009
Start Date ^ICMJE	June 2008
Estimated Primary Completion Date	December 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 13, 2009)	Effects of Plantar Stimulation on Hypotension during Hemodialysis With Adults [ Time Frame: 4 hour treatments ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: January 13, 2009)	Effects of Plantar Stimulation on Treatment Efficacy With Adults on Hemodialysis [ Time Frame: 4 hour treatment ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Effects of Plantar Stimulation on Hypotension, Treatment Efficacy and Quality of Life With Adults on Hemodialysis
Official Title ^ICMJE	the Effects of Plantar Stimulation on Hypotension, Treatment Efficacy and Quality of Life
Brief Summary	For the ESRD patients undergoing hemodialysis treatment, specifically, reflex mediated calf muscle pump stimulation has the potential to significantly reduce the number and magnitude of hypotensive episodes thus enhancing the effectiveness of the dialysis process. Fewer hemodialysis complications during the patient's hemodialysis treatment, would allow treatment sessions to continue to the prescribed volume removal, with much reduced patient recovery time, and the costs associated with this recovery.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Condition ^ICMJE	Hypotension
Intervention ^ICMJE	Device: Effects of Plantar Stimulation Plantar stimulation: Use of a low-intensity mechanical stimulus to the plantar surface (sole) so as to trigger a reflex response causing soleus muscle contraction, and thereby an increase in calf muscle pump activity. The plantar stimulation device (VStim; Juvent Medical Inc., Somerset, NJ) delivers a 50 micrometer displacement to the plantar surface of the foot at 45 Hz. This device has been shown to significantly increase lower limb blood and lymphatic flow when patients use the device while in a seated or supine position.
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Enrollment ^ICMJE	9
Estimated Completion Date	January 2009
Estimated Primary Completion Date	December 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 18 years of age or older; alert and oriented to time, place, and self; able to read and speak the English language; currently receiving hemodialysis treatment approximately 3-4 hour sessions, 3 times a week; received hemodialysis treatments continuously for the several previous months; AND consistently exhibits hypotensive symptoms during dialysis. Exclusion Criteria: receiving hemodialysis as a temporary treatment following a peritoneal dialysis complication or an episode of transplant rejection; receiving hemodialysis at home; OR if they have a Medical History of any the following conditions: deep venous thrombosis, uncontrolled hypertension, pulmonary embolus
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00822653
Other Study ID Numbers ^ICMJE	521-07
Has Data Monitoring Committee	No
Responsible Party	MaryAnn Nemcek, Binghamton University
Study Sponsor ^ICMJE	Binghamton University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Binghamton University
Verification Date	January 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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