Effects of Exercise by Neuromuscular Stimulation in Dialysis Patients

NCT03517553 | Terminated Results DMC FDA Device

• 1 other identifier: 201301731
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Dialysis

Keywords

electrical muscle stimulation

Outcome Measures

Primary Outcomes (1)

• Quadriceps Muscle Strength Measured by a Belt-stabilized Portable Dynamometer

  Muscle strength was measured using a belt-stabilized hand held dynamometer (BSHHD) using a validated technique. Briefly, isometric knee extension strength (torque) was measured with patients seated on an elevated chair and their knees bent at about 90o of flexion (i.e., the legs hanging vertical). Patients are stabilized to the chair with straps around proximal thighs and waist. A dynamometer-stabilizing belt is passed around a bar secured behind the back legs of the chair and over a calibrated hand-held dynamometer that was placed against the anterior leg of the patient just proximal to the malleoli. The patient is asked to perform three leg extensions with the leg separated by 30 seconds of rest. The first effort is sub-maximal to get the patient accustom to the procedure. Then two full strength efforts are performed and used for calculation of average peak force (newtons, N) generated. The test is performed sequentially on both legs at each measurement session.

  Baseline, Start EMS, 2 months and 4 months of EMS training, and 1 month post exercise

Secondary Outcomes (1)

• Leg Composition by Dual Energy X-ray Absorptiometry (DXA).

  Baseline, 2 and 4 months of EMS training

Study Arms (1)

EMS users in ESRD

EXPERIMENTAL

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

Interventions

EMS users in ESRD DEVICE

use of passive electrical muscle stimulation on quadriceps muscle 3 times a week for patients in dialysis

EMS users in ESRD

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Results Point of Contact

• Title: Dr Bradley S. Dixon
• Organization: University of Iowa

bradley-dixon@uiowa.edu

319-356-1626

Study Officials

• Bradley S Dixon, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2017
• First Posted: May 7, 2018
• Study Start: July 29, 2013
• Primary Completion: November 12, 2014
• Study Completion: November 12, 2014
• Last Updated: January 8, 2025
• Results First Posted: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)