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Effects of Exercise by Neuromuscular Stimulation in Dialysis Patients

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ClinicalTrials.gov Identifier: NCT03517553
Recruitment Status : Active, not recruiting
First Posted : May 7, 2018
Last Update Posted : May 7, 2018
Sponsor:
Information provided by (Responsible Party):
Bradley S. Dixon, University of Iowa

Brief Summary:
The investigators propose a pilot feasibility study to determine if exercise delivered by passive electrical muscle stimulation (EMS) in patients with end stage renal disease (ESRD) on hemodialysis improves physical fitness and insulin resistance, outcome markers associated with morbidity and mortality in this population.

Condition or disease Intervention/treatment Phase
Dialysis Device: EMS users in ESRD Not Applicable

Detailed Description:

Subjects who enroll and meet the inclusion and none of the exclusion criteria will first undergo baseline testing including recording of demographic, medical, dialysis and exercise history, taking surveys to assess quality of life and overall mood, measurement of vital signs and anthropomorphic measurements (height, weight, thigh circumference), have blood collected to assess insulin resistance and cytokine levels, measurement of distance walked in 6 minutes and testing of thigh muscle strength.

Subjects will then undergo a 1 month observation period to monitor and optimize their dialysis treatment.

After 1 month the subjects will undergo a repeat assessment of all the baseline testing. They will also undergo a standardized exercise stress test and measurement of body fat and lean body mass with a dual-energy x-ray absorptiometry (DXA) scan.

Subjects then initiate passive electrical muscle stimulation (EMS) delivered by a commercially available FDA approved neuromuscular stimulator ("EMPI 300PV" or its replacement, EMPI Continuum device obtained from EMPI, Inc., St Paul MN) 3 times a week to the quadriceps muscle groups (15 minutes on each side, 30 minutes total) while on hemodialysis. The duration of training will last for 4 months. Subjects will be monitored at regular intervals during the training to make sure they are doing the training correctly and they are not experiencing any problems.

At 2 and 4 months the subjects will undergo again have repeat assessment of the baseline testing as well as undergoing the standardized exercise stress test and a DXA scan.

At 4 months the subjects will all stop the passive exercise training and then will be followed up 1 month later to repeat assessment of all the baseline testing but will not undergoing the standardized exercise stress test and a DXA scan.

For subjects who agree the investigators will also perform a muscle biopsy under local anesthesia before and 4 hours after the first exercise training session and again at 2 and 4 months. This is used to measure messenger RNA response (gene expression testing) to tell what genes are activated during training.

The efficacy of the exercise training will be assessed by change in aerobic capacity measured by maximal oxygen consumption (peak VO2) and quadriceps muscle strength measured

The primary outcome measure will be whether exercise training improves measures of insulin resistance The investigators will also assess whether there is improvement in other inflammatory and oxidative stress cytokines in the blood stream and whether the training improved their physical performance or overall quality of life.

The total duration of the study for any patient is expected to be 6 months.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Exercise Using Electrical Muscle Stimulation in End Stage Kidney Disease
Actual Study Start Date : January 1, 2014
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EMS users in ESRD
Subjects then initiate passive electrical muscle stimulation (EMS) delivered by a commercially available FDA approved neuromuscular stimulator (EMPI 300PV or its replacement, EMPI Continuum device obtained from EMPI, Inc., St Paul MN) 3 times a week to the quadriceps muscle groups (15 minutes on each side, 30 minutes total) while on hemodialysis. The duration of training will last for 4 months. Subjects will be monitored at regular intervals during the training to make sure they are doing the training correctly and they are not experiencing any problems.
Device: EMS users in ESRD
use of passive electrical muscle stimulation on quadriceps muscle 3 times a week for patients in dialysis




Primary Outcome Measures :
  1. Insulin resistance as measured by the serum Leptin-Adiponectin ratio [ Time Frame: Baseline, 8 weeks and 16 weeks while exercising, and 4 weeks post exercise ]
    Serum leptin and adiponectin are measured twice at baseline, after 8 and 16 weeks of exercise and 4 weeks post-exercise by radioimmunoassay after a 12 hour fast. The ratio is a measure of insulin resistance.


Secondary Outcome Measures :
  1. Quadriceps muscle strength measured by a belt-stabilized portable dynamometer [ Time Frame: Baseline, 8 weeks and 16 weeks while exercising, and 4 weeks post exercise ]
    To determine if neuromuscular stimulation improves muscle strength quadriceps muscle strength is measured twice at baseline, at 8 and 16 weeks of exercise and 4 weeks post-exercise using a belt-stabilized portable dynamometer.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Able to provide informed consent
  2. Currently on maintenance hemodialysis for end stage renal disease and expected to stay in the participating dialysis unit for at least 6 months.

Exclusion Criteria:

  1. The presence of a cardiac pacemaker or presence of any other implanted electrical stimulation device
  2. Uncontrolled hypertension as defined by a systolic BP >170 mmHg
  3. Current presence of unstable angina
  4. A heart attack (myocardial infarction) within the last month
  5. Expected survival less than 6 months
  6. Unsuitable for participation based on physician assessment
  7. Pregnancy
  8. Unwilling or unable to give informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03517553


Locations
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United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Bradley S. Dixon
Investigators
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Principal Investigator: Bradley S Dixon, MD University of Iowa

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Responsible Party: Bradley S. Dixon, Associate Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT03517553     History of Changes
Other Study ID Numbers: 201301731
First Posted: May 7, 2018    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Bradley S. Dixon, University of Iowa:
electrical muscle stimulation