Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
6 participants
INTERVENTIONAL
2015-05-31
2015-10-31
Brief Summary
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Patients with cachexia can benefit from transcutaneous electrical neuromuscular stimulation (TENS). It is applied to strengthen the musculature and improve exercise tolerance and quality of life.
It is unclear if application of TENS can cause electromagnetic interference (EMI) in patients with Optimizer® pacemaker systems for improvement of heart failure.
This pilot safety study enrolled 6 patients with chronic heart failure and reduced left ventricular ejection fraction. All patients had an Optimizer® pacemaker system implanted for a minimum of 6 months, no patients had any ventricular arrhythmic episode 3 months prior to the study, and all were in clinically stable condition and willing to participate in this study.
Neuromuscular stimulation was administered via TENS in 4 different modes (HF, LF, Burst, MF) on the right and left musculus trapezius and on both musculi quadriceps femoris. All patients were tested for EMI without or with cardiac contractility modulation (CCM) delivery of the Optimizer®-system respectively.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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before-after
TENS stimulation neck and thigh
Stimulette r4x
Interventions
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Stimulette r4x
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
99 Years
MALE
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Michael Wolzt, Prof. MD
Prof Dr Michael Wolzt
Other Identifiers
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1067_2015
Identifier Type: -
Identifier Source: org_study_id
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