Randomized, Controlled Study to Investigate the Effect of Neuromuscular Electrical Stimulation (NMES) on Muscle Metabolism of Abdominal Surgical Patients
The Effect of Neuromuscular Electrical Stimulation on Muscle Metabolism of Major Abdominal Surgical Patients
1 other identifier
interventional
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 25, 2008
CompletedFirst Posted
Study publicly available on registry
March 13, 2008
CompletedMarch 13, 2008
March 1, 2008
February 25, 2008
March 12, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
mRNA level of IGF-1Ea
Secondary Outcomes (1)
mRNA level of MGF, total RNA content, total protein content, ubiquitin conjugated proteins, proteasome activity
Study Arms (2)
A
ACTIVE COMPARATORB
SHAM COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- intended for major abdominal surgery
- more than 18 years old
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Physical Medicine and Rehabilitation, Social Medical Centre South
Vienna, Vienna, 1100, Austria
Related Publications (8)
Roth E, Valentini L, Holzenbein T, Winkler S, Sautner T, Hortnagl 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)(Pt 3):765-9. doi: 10.1042/bj2960765.
PMID: 8280075BACKGROUNDHerridge 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. doi: 10.1056/NEJMoa022450.
PMID: 12594312BACKGROUNDBiolo 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. doi: 10.1113/jphysiol.2004.066365. Epub 2004 May 6.
PMID: 15131238BACKGROUNDDeVol 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. doi: 10.1152/ajpendo.1990.259.1.E89.
PMID: 2372054BACKGROUNDHameed 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. doi: 10.1113/jphysiol.2002.032136. Epub 2002 Dec 20.
PMID: 12562960BACKGROUNDBodine 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. doi: 10.1126/science.1065874. Epub 2001 Oct 25.
PMID: 11679633BACKGROUNDQuittan 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.
PMID: 11237275BACKGROUNDStrasser 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.
PMID: 19387331DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Quittan, PhD, MD
Institute of Physical Medicine and Rehabilitation, Social Medical Centre South
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 25, 2008
First Posted
March 13, 2008
Study Start
December 1, 2005
Last Updated
March 13, 2008
Record last verified: 2008-03