Effects of Exercise by Neuromuscular Stimulation in Dialysis Patients
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 5/9/2018 |
| Start Date: | January 1, 2014 |
| End Date: | June 1, 2020 |
Effects of Exercise Using Electrical Muscle Stimulation in End Stage Kidney Disease
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.
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.
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.
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.
We found this trial at
1
site
University of Iowa With just over 30,000 students, the University of Iowa is one of...
Click here to add this to my saved trials
