Effects of Exercise by Neuromuscular Stimulation in Dialysis Patients

NCT ID: NCT03517553

Last Updated: 2025-01-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-29
• Study Completion Date: 2014-11-12

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.

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.

Conditions

Dialysis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

EMS users in ESRD

Intervention Type: DEVICE

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

Interventions

EMS users in ESRD

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

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Iowa

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bradley S Dixon, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa

Iowa City, Iowa, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

201301731

Identifier Type: -

Identifier Source: org_study_id