Clinical trial NCT03517553: Effects of Exercise by Neuromuscular Stimulation in Dialysis Patients
Official title: Effects of Exercise Using Electrical Muscle Stimulation in End Stage Kidney Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dialysis
Keywords: electrical muscle stimulation
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2018-05-07
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Quadriceps Muscle Strength Measured by a Belt-stabilized Portable Dynamometer
timeFrame: Baseline, Start EMS, 2 months and 4 months of EMS training, and 1 month post exercise
Secondary outcomes:
measure: Leg Composition by Dual Energy X-ray Absorptiometry (DXA).
timeFrame: Baseline, 2 and 4 months of EMS training
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Bradley S Dixon, MD
role: PRINCIPAL_INVESTIGATOR
References: