Dialysis
Conditions
Keywords
electrical muscle stimulation
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.
Interventions
DEVICEEMS users in ESRD
use of passive electrical muscle stimulation on quadriceps muscle 3 times a week for patients in dialysis
Sponsors
University of Iowa
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quadriceps Muscle Strength Measured by a Belt-stabilized Portable Dynamometer | Baseline, Start EMS, 2 months and 4 months of EMS training, and 1 month post exercise | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Leg Composition by Dual Energy X-ray Absorptiometry (DXA). | Baseline, 2 and 4 months of EMS training | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment from July 29, 2013 to March 25, 2014. All patients were from the outpatient dialysis program at the University of Iowa.
Pre-assignment details
There was a 4 week care-optimization phase to make sure dialysis care was optimized before starting and to allow 2 separate measurements of baseline leg muscle strength. One patient withdrew from the study during this phase and did not complete the pre-EMS initiation measurements.
Participants by arm
| Arm | Count |
|---|---|
| EMS Users This was a longitudinal cohort study where all patients were entered into one study group receiving electrical muscle stimulation 3x/week for 30 minutes each session for a total of 16 weeks followed by a 4 week post-EMS study visit. | 7 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | EMS Users |
|---|---|
| Age, Continuous | 68.9 years STANDARD_DEVIATION 6.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| History diabetes | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 7 |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 1 / 7 |
Outcome results
Primary
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
Population: Longitudinal prospective study of the effect of electrical muscle stimulation (EMS) on muscle strength.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Right Quadriceps Strength. | Quadriceps Muscle Strength Measured by a Belt-stabilized Portable Dynamometer | Start EMS | 222.4 Force (Newtons) | Standard Deviation 80.4 |
| Right Quadriceps Strength. | Quadriceps Muscle Strength Measured by a Belt-stabilized Portable Dynamometer | 4 months EMS Training | 235.8 Force (Newtons) | Standard Deviation 59.9 |
| Right Quadriceps Strength. | Quadriceps Muscle Strength Measured by a Belt-stabilized Portable Dynamometer | 2 months EMS Training | 219.2 Force (Newtons) | Standard Deviation 73.6 |
| Right Quadriceps Strength. | Quadriceps Muscle Strength Measured by a Belt-stabilized Portable Dynamometer | 1 month Post-EMS training | 226.4 Force (Newtons) | Standard Deviation 63.8 |
| Right Quadriceps Strength. | Quadriceps Muscle Strength Measured by a Belt-stabilized Portable Dynamometer | Baseline | 221.2 Force (Newtons) | Standard Deviation 81.8 |
| Left Quadriceps Strength | Quadriceps Muscle Strength Measured by a Belt-stabilized Portable Dynamometer | 1 month Post-EMS training | 151.9 Force (Newtons) | Standard Deviation 88.8 |
| Left Quadriceps Strength | Quadriceps Muscle Strength Measured by a Belt-stabilized Portable Dynamometer | Baseline | 227.4 Force (Newtons) | Standard Deviation 65.6 |
| Left Quadriceps Strength | Quadriceps Muscle Strength Measured by a Belt-stabilized Portable Dynamometer | Start EMS | 213.5 Force (Newtons) | Standard Deviation 81.7 |
| Left Quadriceps Strength | Quadriceps Muscle Strength Measured by a Belt-stabilized Portable Dynamometer | 2 months EMS Training | 213.9 Force (Newtons) | Standard Deviation 50.4 |
| Left Quadriceps Strength | Quadriceps Muscle Strength Measured by a Belt-stabilized Portable Dynamometer | 4 months EMS Training | 204.7 Force (Newtons) | Standard Deviation 80.3 |
p-value: 0.999Kruskal-Wallis
p-value: 0.768Kruskal-Wallis
Secondary
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
Population: One of the 7 enrolled patients dropped out and did not undergo DXA measurements.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Right Quadriceps Strength. | Leg Composition by Dual Energy X-ray Absorptiometry (DXA). | 2 Months EMS Training | 12484 cm squared | Standard Error 1413 |
| Right Quadriceps Strength. | Leg Composition by Dual Energy X-ray Absorptiometry (DXA). | Baseline | 12458 cm squared | Standard Error 1501 |
| Right Quadriceps Strength. | Leg Composition by Dual Energy X-ray Absorptiometry (DXA). | 4 Months EMS Training | 12540 cm squared | Standard Error 1553 |
| Left Quadriceps Strength | Leg Composition by Dual Energy X-ray Absorptiometry (DXA). | 2 Months EMS Training | 4835 cm squared | Standard Error 1042 |
| Left Quadriceps Strength | Leg Composition by Dual Energy X-ray Absorptiometry (DXA). | Baseline | 4861 cm squared | Standard Error 1178 |
| Left Quadriceps Strength | Leg Composition by Dual Energy X-ray Absorptiometry (DXA). | 4 Months EMS Training | 4912 cm squared | Standard Error 1118 |
| Right Thigh Lean Mass | Leg Composition by Dual Energy X-ray Absorptiometry (DXA). | 2 Months EMS Training | 7417 cm squared | Standard Error 542 |
| Right Thigh Lean Mass | Leg Composition by Dual Energy X-ray Absorptiometry (DXA). | Baseline | 7369 cm squared | Standard Error 481 |
| Right Thigh Lean Mass | Leg Composition by Dual Energy X-ray Absorptiometry (DXA). | 4 Months EMS Training | 7392 cm squared | Standard Error 550 |
| Left Total Thigh Mass | Leg Composition by Dual Energy X-ray Absorptiometry (DXA). | 2 Months EMS Training | 12842 cm squared | Standard Error 1660 |
| Left Total Thigh Mass | Leg Composition by Dual Energy X-ray Absorptiometry (DXA). | Baseline | 12492 cm squared | Standard Error 1498 |
| Left Total Thigh Mass | Leg Composition by Dual Energy X-ray Absorptiometry (DXA). | 4 Months EMS Training | 12831 cm squared | Standard Error 1706 |
| Left Thigh Fat Mass | Leg Composition by Dual Energy X-ray Absorptiometry (DXA). | 2 Months EMS Training | 5109 cm squared | Standard Error 1164 |
| Left Thigh Fat Mass | Leg Composition by Dual Energy X-ray Absorptiometry (DXA). | Baseline | 4946 cm squared | Standard Error 1177 |
| Left Thigh Fat Mass | Leg Composition by Dual Energy X-ray Absorptiometry (DXA). | 4 Months EMS Training | 5126 cm squared | Standard Error 1220 |
| Left Thigh Lean Mass | Leg Composition by Dual Energy X-ray Absorptiometry (DXA). | Baseline | 7301 cm squared | Standard Error 471 |
| Left Thigh Lean Mass | Leg Composition by Dual Energy X-ray Absorptiometry (DXA). | 4 Months EMS Training | 7453 cm squared | Standard Error 582 |
| Left Thigh Lean Mass | Leg Composition by Dual Energy X-ray Absorptiometry (DXA). | 2 Months EMS Training | 7489 cm squared | Standard Error 607 |
p-value: 0.869Kruskal-Wallis
p-value: 0.813Kruskal-Wallis
p-value: 0.978Kruskal-Wallis
p-value: 0.731Kruskal-Wallis
p-value: 0.703Kruskal-Wallis
p-value: 0.909Kruskal-Wallis