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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kenneth McLeod, Binghamton University
ClinicalTrials.gov Identifier:
NCT00822653
First received: January 13, 2009
Last updated: September 17, 2013
Last verified: September 2013

January 13, 2009
September 17, 2013
June 2008
December 2008   (final data collection date for primary outcome measure)
Effects of Plantar Stimulation on Hypotension during Hemodialysis With Adults [ Time Frame: 4 hour treatments ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00822653 on ClinicalTrials.gov Archive Site
Effects of Plantar Stimulation on Treatment Efficacy With Adults on Hemodialysis [ Time Frame: 4 hour treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Effects of Plantar Stimulation on Hypotension, Treatment Efficacy and Quality of Life With Adults on Hemodialysis
the Effects of Plantar Stimulation on Hypotension, Treatment Efficacy and Quality of Life

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Hypotension
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.

Observational studies
pre and post tests based on juvent device use
Intervention: Device: Effects of Plantar Stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
January 2010
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 18 years of age or older;
  2. alert and oriented to time, place, and self;
  3. able to read and speak the English language;
  4. currently receiving hemodialysis treatment approximately 3-4 hour sessions, 3 times a week;
  5. received hemodialysis treatments continuously for the several previous months; AND
  6. consistently exhibits hypotensive symptoms during dialysis.

Exclusion Criteria:

  1. receiving hemodialysis as a temporary treatment following a peritoneal dialysis complication or an episode of transplant rejection;
  2. receiving hemodialysis at home; OR
  3. if they have a Medical History of any the following conditions: deep venous thrombosis, uncontrolled hypertension, pulmonary embolus
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00822653
521-07
No
Kenneth McLeod, Binghamton University
Binghamton University
Not Provided
Not Provided
Binghamton University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP