Randomized, Controlled Study to Investigate the Effect of Neuromuscular Electrical Stimulation (NMES) on Muscle Metabolism of Abdominal Surgical Patients

This study has been completed.

Sponsor:

Collaborators:

Department of Surgery, Social Medical Centre South, Vienna, Austria

Institute for Pathology and Microbiology, Social Medical Centre South, Vienna, Austria

Information provided by:

Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT00635440

First received: February 25, 2008

Last updated: March 12, 2008

Last verified: March 2008

History of Changes

Purpose

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.

Condition	Intervention
Muscular Atrophy	Device: neuromuscular electrical stimulation: Cefar-Sport (CefarCompex Scandinavia AB)

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Investigator) Primary Purpose: Basic Science
Official Title:	The Effect of Neuromuscular Electrical Stimulation on Muscle Metabolism of Major Abdominal Surgical Patients

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:

mRNA level of IGF-1Ea

Secondary Outcome Measures:

mRNA level of MGF, total RNA content, total protein content, ubiquitin conjugated proteins, proteasome activity

Enrollment:	26
Study Start Date:	December 2005

Arms	Assigned Interventions
Active Comparator: A	Device: neuromuscular electrical stimulation: Cefar-Sport (CefarCompex Scandinavia AB) Electrical stimuli of 50 Hz (pulse width 0.25ms, 8 sec on, 4 sec off) were applied daily for 30 min, for 4 days, starting on the first postoperative day.The amplitude of the electrical stimuli in the stimulated leg was adjusted to ensure maximum tolerable muscle contraction.
Sham Comparator: B	Device: neuromuscular electrical stimulation: Cefar-Sport (CefarCompex Scandinavia AB) Electrical stimuli of 50 Hz (pulse width 0.25ms, 8 sec on, 4 sec off) were applied daily for 30 min, for 4 days, starting on the first postoperative day. Current was increased until the patient could feel a tingling sensation but no muscle contraction was visible or palpable.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00635440

Locations

Austria
Institute of Physical Medicine and Rehabilitation, Social Medical Centre South
Vienna, Austria, 1100

Sponsors and Collaborators

Medical University of Vienna

Department of Surgery, Social Medical Centre South, Vienna, Austria

Institute for Pathology and Microbiology, Social Medical Centre South, Vienna, Austria

Investigators

Principal Investigator:

Michael Quittan, PhD, MD

Institute of Physical Medicine and Rehabilitation, Social Medical Centre South

More Information

Publications:

Roth E, Valentini L, Hölzenbein T, Winkler S, Sautner T, Hörtnagl H, Karner J. Acute effects of insulin-like growth factor I on inter-organ amino acid flux in protein-catabolic dogs. Biochem J. 1993 Dec 15;296 ( Pt 3):765-9.

Herridge MS, Cheung AM, Tansey CM, Matte-Martyn A, Diaz-Granados N, Al-Saidi F, Cooper AB, Guest CB, Mazer CD, Mehta S, Stewart TE, Barr A, Cook D, Slutsky AS; Canadian Critical Care Trials Group. One-year outcomes in survivors of the acute respiratory distress syndrome. N Engl J Med. 2003 Feb 20;348(8):683-93.

Biolo G, Ciocchi B, Lebenstedt M, Barazzoni R, Zanetti M, Platen P, Heer M, Guarnieri G. Short-term bed rest impairs amino acid-induced protein anabolism in humans. J Physiol. 2004 Jul 15;558(Pt 2):381-8. Epub 2004 May 6.

DeVol DL, Rotwein P, Sadow JL, Novakofski J, Bechtel PJ. Activation of insulin-like growth factor gene expression during work-induced skeletal muscle growth. Am J Physiol. 1990 Jul;259(1 Pt 1):E89-95.

Hameed M, Orrell RW, Cobbold M, Goldspink G, Harridge SD. Expression of IGF-I splice variants in young and old human skeletal muscle after high resistance exercise. J Physiol. 2003 Feb 15;547(Pt 1):247-54. Epub 2002 Dec 20.

Bodine SC, Latres E, Baumhueter S, Lai VK, Nunez L, Clarke BA, Poueymirou WT, Panaro FJ, Na E, Dharmarajan K, Pan ZQ, Valenzuela DM, DeChiara TM, Stitt TN, Yancopoulos GD, Glass DJ. Identification of ubiquitin ligases required for skeletal muscle atrophy. Science. 2001 Nov 23;294(5547):1704-8. Epub 2001 Oct 25.

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Strasser EM, Stättner 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.

Responsible Party:	Institute of Physical Medicine and Rehabilitation, Social Medical Centre South, Vienna
ClinicalTrials.gov Identifier:	NCT00635440 History of Changes
Other Study ID Numbers:	Muscle-2446
Study First Received:	February 25, 2008
Last Updated:	March 12, 2008
Health Authority:	Austria: Ethikkommission

Keywords provided by Medical University of Vienna:

skeletal muscle
ubiquitin
proteasome
IGF-1

MGF
protein catabolism
neuromuscular electrical stimulation
Investigate effect of NMES on muscle metabolism of catabolic patients

Additional relevant MeSH terms:

Muscular Atrophy
Atrophy
Neuromuscular Manifestations
Neurologic Manifestations

Nervous System Diseases
Pathological Conditions, Anatomical
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013

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