An interventional study of EMS users in ESRD in Dialysis, sponsored by University of Iowa. Terminated at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-01-08.
Sponsored by University of Iowa · Not applicable, Interventional, and Treatment
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.
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.
University of Iowa is the lead sponsor of 276 studies on the registry; 35 are open to participants now.
Of its 44 completed or terminated interventional studies of FDA-regulated products, 39 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
Time frame: Baseline, Start EMS, 2 months and 4 months of EMS training, and 1 month post exercise
Leg Composition by Dual Energy X-ray Absorptiometry (DXA).
Advanced body composition analysis will be performed by DXA scan to measure regional fat and lean mass before starting EMS training and again after 2 and 4 months of EMS training. Specific areas of interest will be in determining whether EMS training produces the expected changes in thigh fat and muscle mass. The test is performed in the CRU at the University of Iowa using a Discovery A DXA scanner with the latest software version package (Hologic Inc., Bedford, MA). The advanced body composition analysis software package measures total regional body composition (cm2) using a validated technique that produces comparable results to a CT scan with less cost and radiation exposure.The total radiation dose is less than one tenth that of a standard CXR and equivalent to one-day exposure to natural background radiation. Patients will be asked to report to the CRU dressed metal-free (no zippers, jewelry, piercings, underwire bra, etc.). Each study will take approximately 30 minutes.
Time frame: Baseline, 2 and 4 months of EMS training
Recruitment from July 29, 2013 to March 25, 2014. All patients were from the outpatient dialysis program at the University of Iowa.
| Milestone | EMS Users in ESRD |
|---|---|
| Started | 7 |
| Completed | 5 |
| Not completed | 2 |
| Withdrew: Withdrawal by subject | 2 |
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.
| Force (Newtons) | Right Quadriceps Strength. | Left Quadriceps Strength |
|---|---|---|
| Baseline | 221.2 ± 81.8 | 227.4 ± 65.6 |
| Start EMS | 222.4 ± 80.4 | 213.5 ± 81.7 |
| 2 months EMS Training | 219.2 ± 73.6 | 213.9 ± 50.4 |
| 4 months EMS Training | 235.8 ± 59.9 | 204.7 ± 80.3 |
| 1 month Post-EMS training | 226.4 ± 63.8 | 151.9 ± 88.8 |
Advanced body composition analysis will be performed by DXA scan to measure regional fat and lean mass before starting EMS training and again after 2 and 4 months of EMS training. Specific areas of interest will be in determining whether EMS training produces the expected changes in thigh fat and muscle mass. The test is performed in the CRU at the University of Iowa using a Discovery A DXA scanner with the latest software version package (Hologic Inc., Bedford, MA). The advanced body composition analysis software package measures total regional body composition (cm2) using a validated technique that produces comparable results to a CT scan with less cost and radiation exposure.The total radiation dose is less than one tenth that of a standard CXR and equivalent to one-day exposure to natural background radiation. Patients will be asked to report to the CRU dressed metal-free (no zippers, jewelry, piercings, underwire bra, etc.). Each study will take approximately 30 minutes.
| cm squared | Right Total Thigh Mass | Right Thigh Fat Mass | Right Thigh Lean Mass | Left Total Thigh Mass | Left Thigh Fat Mass | Left Thigh Lean Mass |
|---|---|---|---|---|---|---|
| Baseline | 12458 ± 1501 | 4861 ± 1178 | 7369 ± 481 | 12492 ± 1498 | 4946 ± 1177 | 7301 ± 471 |
| 2 Months EMS Training | 12484 ± 1413 | 4835 ± 1042 | 7417 ± 542 | 12842 ± 1660 | 5109 ± 1164 | 7489 ± 607 |
| 4 Months EMS Training | 12540 ± 1553 | 4912 ± 1118 | 7392 ± 550 | 12831 ± 1706 | 5126 ± 1220 | 7453 ± 582 |
Collected over Adverse events were collected for 24 weeks on each patient. Adverse events were collected at the time of each study visit up to the last study visit which was 4 weeks after stopping the EMS training. Adverse events were also collected at any time we became aware of an adverse event during the period of the 24 weeks the patient was enrolled in the study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| EMS Training Group | 0/7 (0%) | 1/7 (14.3%) | 0/7 (0%) |
| Event | EMS Training Group |
|---|---|
| Transient ischemic attackNervous system disorders | 1/7 |
| Age, Continuous(years) | EMS Users |
|---|---|
| Mean | 68.9 ± 6.6 |
| Sex: Female, Male(Participants) | EMS Users |
|---|---|
| Female | 3 |
| Male | 4 |
| Ethnicity (NIH/OMB)(Participants) | EMS Users |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 7 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | EMS Users |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 6 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | EMS Users |
|---|---|
| United States | 7 |
| History diabetes(Participants) | EMS Users |
|---|---|
| Count of participants | 6 |
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University of Iowa