Clinical trial NCT00635440: Randomized, Controlled Study to Investigate the Effect of Neuromuscular Electrical Stimulation (NMES) on Muscle Metabolism of Abdominal Surgical Patients
Official title: The Effect of Neuromuscular Electrical Stimulation on Muscle Metabolism of Major Abdominal Surgical Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscular Atrophy
Keywords: skeletal muscle
ubiquitin
proteasome
IGF-1
MGF
protein catabolism
neuromuscular electrical stimulation
Investigate effect of NMES on muscle metabolism of catabolic patients
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Department of Surgery, Social Medical Centre South, Vienna, Austria
name: Institute for Pathology and Microbiology, Social Medical Centre South, Vienna, Austria
First posted: 2008-03-13
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Skeletal muscle atrophy is associated with catabolic conditions such as major surgical interventions and leads to reduced muscle strength, increased clinical complications and prolonged convalescence. Several studies revealed immobilisation as a major stimulus for muscle wasting in severely ill patients. This study investigates the potency of neuromuscular electrical stimulation on skeletal muscle growth factors and degradation processes in major abdominal surgery patients.


Eligibility criteria: Inclusion Criteria:

* intended for major abdominal surgery
* more than 18 years old

Exclusion Criteria:

* neuromuscular diseases
* immobility before surgery
* arterial occlusive disease Fontaine stadium IV
* clinical or laboratory signs of inflammation or sepsis
* cachexia
* diseases of the musculoskeletal systems contraindicating electrical stimulation

Primary outcomes:
measure: mRNA level of IGF-1Ea
Secondary outcomes:
measure: mRNA level of MGF, total RNA content, total protein content, ubiquitin conjugated proteins, proteasome activity
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Institute of Physical Medicine and Rehabilitation, Social Medical Centre South
Study officials:
affiliation: Institute of Physical Medicine and Rehabilitation, Social Medical Centre South
name: Michael Quittan, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Quittan M, Wiesinger GF, Sturm B, Puig S, Mayr W, Sochor A, Paternostro T, Resch KL, Pacher R, Fialka-Moser V. Improvement of thigh muscles by neuromuscular electrical stimulation in patients with refractory heart failure: a single-blind, randomized, controlled trial. Am J Phys Med Rehabil. 2001 Mar;80(3):206-14; quiz 215-6, 224. doi: 10.1097/00002060-200103000-00011.
citation: Strasser EM, Stattner S, Karner J, Klimpfinger M, Freynhofer M, Zaller V, Graf A, Wessner B, Bachl N, Roth E, Quittan M. Neuromuscular electrical stimulation reduces skeletal muscle protein degradation and stimulates insulin-like growth factors in an age- and current-dependent manner: a randomized, controlled clinical trial in major abdominal surgical patients. Ann Surg. 2009 May;249(5):738-43. doi: 10.1097/SLA.0b013e3181a38e71.