Trial Outcomes & Findings for Effects of Exercise by Neuromuscular Stimulation in Dialysis Patients (NCT NCT03517553)

Last Updated: 2025-01-08

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

15 participants

Primary outcome timeframe

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

Results posted on

2025-01-08

Participant Flow

Recruitment from July 29, 2013 to March 25, 2014. All patients were from the outpatient dialysis program at the University of Iowa.

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.

Participant milestones

Participant milestones
Measure	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. EMS users in ESRD: use of passive electrical muscle stimulation on quadriceps muscle 3 times a week for patients in dialysis
Overall Study STARTED	7
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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. EMS users in ESRD: use of passive electrical muscle stimulation on quadriceps muscle 3 times a week for patients in dialysis
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Effects of Exercise by Neuromuscular Stimulation in Dialysis Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EMS Users n=7 Participants 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.
Age, Continuous	68.9 years STANDARD_DEVIATION 6.6 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants
History diabetes	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Right Quadriceps Strength. n=7 Participants The effect of electrical muscle stimulation (EMS) on right quadriceps muscle strength will be assessed 5 times at baseline, pre-EMS training, at 8 and 16 weeks of EMS training and again 4 weeks after stopping EMS training. Right quadriceps muscle strength will be determined using a belt-stabilized portable dynamometer. This will determine if EMS produced an increase in right quadriceps strength after 8 and 16 weeks of training. It will also determine how rapidly the effect on muscle strength is lost after stopping EMS training.	Left Quadriceps Strength n=7 Participants The effect of electrical muscle stimulation (EMS) on left quadriceps muscle strength will be assessed 5 times at baseline, pre-EMS training, at 8 and 16 weeks of EMS training and again 4 weeks after stopping EMS training. Left quadriceps muscle strength will be determined using a belt-stabilized portable dynamometer. This will determine if EMS produced an increase in left quadriceps strength after 8 and 16 weeks of training. It will also determine how rapidly the effect on muscle strength is lost after stopping EMS training.	Right Thigh Lean Mass DXA measurement of lean mass of right thigh	Left Total Thigh Mass DXA measurement of total mass of left thigh	Left Thigh Fat Mass DXA measurement of fat mass of left thigh	Left Thigh Lean Mass DXA measurement of lean mass of right thigh
Quadriceps Muscle Strength Measured by a Belt-stabilized Portable Dynamometer Baseline	221.2 Force (Newtons) Standard Deviation 81.8	227.4 Force (Newtons) Standard Deviation 65.6	—	—	—	—
Quadriceps Muscle Strength Measured by a Belt-stabilized Portable Dynamometer Start EMS	222.4 Force (Newtons) Standard Deviation 80.4	213.5 Force (Newtons) Standard Deviation 81.7	—	—	—	—
Quadriceps Muscle Strength Measured by a Belt-stabilized Portable Dynamometer 2 months EMS Training	219.2 Force (Newtons) Standard Deviation 73.6	213.9 Force (Newtons) Standard Deviation 50.4	—	—	—	—
Quadriceps Muscle Strength Measured by a Belt-stabilized Portable Dynamometer 4 months EMS Training	235.8 Force (Newtons) Standard Deviation 59.9	204.7 Force (Newtons) Standard Deviation 80.3	—	—	—	—
Quadriceps Muscle Strength Measured by a Belt-stabilized Portable Dynamometer 1 month Post-EMS training	226.4 Force (Newtons) Standard Deviation 63.8	151.9 Force (Newtons) Standard Deviation 88.8	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, 2 and 4 months of EMS training

Population: One of the 7 enrolled patients dropped out and did not undergo DXA measurements.

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.

Outcome measures

Outcome measures
Measure	Right Quadriceps Strength. n=6 Participants The effect of electrical muscle stimulation (EMS) on right quadriceps muscle strength will be assessed 5 times at baseline, pre-EMS training, at 8 and 16 weeks of EMS training and again 4 weeks after stopping EMS training. Right quadriceps muscle strength will be determined using a belt-stabilized portable dynamometer. This will determine if EMS produced an increase in right quadriceps strength after 8 and 16 weeks of training. It will also determine how rapidly the effect on muscle strength is lost after stopping EMS training.	Left Quadriceps Strength n=6 Participants The effect of electrical muscle stimulation (EMS) on left quadriceps muscle strength will be assessed 5 times at baseline, pre-EMS training, at 8 and 16 weeks of EMS training and again 4 weeks after stopping EMS training. Left quadriceps muscle strength will be determined using a belt-stabilized portable dynamometer. This will determine if EMS produced an increase in left quadriceps strength after 8 and 16 weeks of training. It will also determine how rapidly the effect on muscle strength is lost after stopping EMS training.	Right Thigh Lean Mass n=6 Participants DXA measurement of lean mass of right thigh	Left Total Thigh Mass n=6 Participants DXA measurement of total mass of left thigh	Left Thigh Fat Mass n=6 Participants DXA measurement of fat mass of left thigh	Left Thigh Lean Mass n=6 Participants DXA measurement of lean mass of right thigh
Leg Composition by Dual Energy X-ray Absorptiometry (DXA). Baseline	12458 cm squared Standard Error 1501	4861 cm squared Standard Error 1178	7369 cm squared Standard Error 481	12492 cm squared Standard Error 1498	4946 cm squared Standard Error 1177	7301 cm squared Standard Error 471
Leg Composition by Dual Energy X-ray Absorptiometry (DXA). 2 Months EMS Training	12484 cm squared Standard Error 1413	4835 cm squared Standard Error 1042	7417 cm squared Standard Error 542	12842 cm squared Standard Error 1660	5109 cm squared Standard Error 1164	7489 cm squared Standard Error 607
Leg Composition by Dual Energy X-ray Absorptiometry (DXA). 4 Months EMS Training	12540 cm squared Standard Error 1553	4912 cm squared Standard Error 1118	7392 cm squared Standard Error 550	12831 cm squared Standard Error 1706	5126 cm squared Standard Error 1220	7453 cm squared Standard Error 582

Adverse Events

EMS Training Group

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	EMS Training Group n=7 participants at risk This is a longitudinal pilot study of electrical muscle stimulation (EMS training) on outcomes measures such as quadriceps strength. All participants under go the same protocol of EMS training. EMS is provided sequentially for 15 minutes to both the right and left quadriceps muscle groups three times a week while on hemodialysis. EMS is delivered to the quadriceps muscle groups using a neuromuscular electrical stimulator (using either the EMPI 300PV or its replacement, the Continuum device, EMPI, Inc). The device generates electrical impulses that are delivered to nerves stimulating the muscles through electrodes applied to the skin surface. Patients are taught how to place the adherent electrode pads over the quadriceps muscles on the upper thigh a few inches below the anterior iliac crest and just above the patella bilaterally. The patient will feel contraction of the muscles and may feel mild shortness of breath and tingling of the skin but otherwise is expected to tolerate the stimulation well. The first intervention will be observed through the entire treatment. If the patient feels excessively fatigued or other untoward signs the stimulator will be turned off until they feel better and then restarted to achieve the full treatment time.
Nervous system disorders Transient ischemic attack	14.3% 1/7 • Number of events 1 • 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. Questions asked of the participant at each visit: Is there a new medical diagnosis since the last visit? Specifically have you developed: Congestive heart failure (NYHA Grade); Myocardial infarction; Angina; Coronary angioplasty or bypass surgery; Carotid endarterectomy; Cardiac arrhythmias or conduction problems; Pericardial disease or pericarditis; Stroke or TIA; Claudication; Lower extremity angioplasty or bypass surgery; Amputation; Other new diagnosis; Any hospitalizations?

Other adverse events

Adverse event data not reported

Additional Information

Dr Bradley S. Dixon

University of Iowa

Phone: 319-356-1626

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place