DialysisNCT03517553
Effects of Exercise by Neuromuscular Stimulation in Dialysis Patients
A study testing EMS users in ESRD in people with Dialysis, run by University of Iowa at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Dialysis
- What is being tested?
- EMS users in ESRD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2013to 12 Nov 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide informed consent
- Currently on maintenance hemodialysis for end stage renal disease and expected to stay in the participating dialysis unit for at least 6 months.
Who cannot join
- The presence of a cardiac pacemaker or presence of any other implanted electrical stimulation device
- Uncontrolled hypertension as defined by a systolic BP >170 mmHg
- Current presence of unstable angina
- A heart attack (myocardial infarction) within the last month
- Expected survival less than 6 months
- Unsuitable for participation based on physician assessment
- Pregnancy
- Unwilling or unable to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Dialysis
- Being tested
- EMS users in ESRD
- Keywords
- electrical muscle stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMS users in ESRDDevice
use of passive electrical muscle stimulation on quadriceps muscle 3 times a week for patients in dialysis
| Study group | Role | What they receive |
|---|---|---|
| EMS users in ESRD | Experimental | 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. Receives: Device: EMS users in ESRD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Start EMS, 2 months and 4 months of EMS training, and 1 month post exercise
Secondary outcomes (1)
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.
Measured: Baseline, 2 and 4 months of EMS training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2018
- Study start29 Jul 2013
- Primary completion12 Nov 2014
- Study completion12 Nov 2014
Why it stopped: Study subjects that were enrolled all completed all visits. PI is currently unable to work on analyzing results
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DialysisStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bradley S Dixon, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03517553
- Sponsor's protocol ID
- 201301731
- Status last verified
- Jan 2025
- First submitted
- 19 Feb 2017
- Last updated
- 8 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise Using Electrical Muscle Stimulation in End Stage Kidney Disease
- ClinicalTrials.gov ID
- NCT03517553
- Acronym / sponsor ID
- 201301731
- Conditions
- Dialysis
- Keywords
- electrical muscle stimulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study subjects that were enrolled all completed all visits. PI is currently unable to work on analyzing results
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 29 Jul 2013 (actual)
- Primary completion
- 12 Nov 2014 (actual)
- Study completion
- 12 Nov 2014 (actual)
- First posted
- 7 May 2018 (actual)
- Results
- Posted 8 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EMS users in ESRD | Experimental | Device: EMS users in ESRDSubjects 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Able to provide informed consent
- Currently on maintenance hemodialysis for end stage renal disease and expected to stay in the participating dialysis unit for at least 6 months.
Key exclusion criteria (8 listed)
- The presence of a cardiac pacemaker or presence of any other implanted electrical stimulation device
- Uncontrolled hypertension as defined by a systolic BP >170 mmHg
- Current presence of unstable angina
- A heart attack (myocardial infarction) within the last month
- Expected survival less than 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMS users in ESRDuse of passive electrical muscle stimulation on quadriceps muscle 3 times a week for patients in dialysis | Device | EMS users in ESRD |
Primary outcome
Quadriceps Muscle Strength Measured by a Belt-stabilized Portable Dynamometer
Time frame: 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.
1 secondary outcome
Leg Composition by Dual Energy X-ray Absorptiometry (DXA).
Time frame: Baseline, 2 and 4 months of EMS training
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradley S Dixon, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMS users in ESRD in people with Dialysis, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quadriceps Muscle Strength Measured by a Belt-stabilized Portable Dynamometer (time frame: Baseline, Start EMS, 2 months and 4 months of EMS training, and 1 month post exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.