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

Muscular Atrophy Clinical Trial

Official title:

The Effect of Neuromuscular Electrical Stimulation on Muscle Metabolism of Major Abdominal Surgical Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00635440
• Other study ID #: Muscle-2446
• Status: Completed
• Phase: N/A
• First received: February 25, 2008
• Last updated: March 12, 2008
• Start date: December 2005

Study information

• Verified date: March 2008
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Muscular Atrophy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Austria	Institute of Physical Medicine and Rehabilitation, Social Medical Centre South	Vienna

Sponsors (3)

Lead Sponsor	Collaborator
Medical University of Vienna	Department of Surgery, Social Medical Centre South, Vienna, Austria, Institute for Pathology and Microbiology, Social Medical Centre South, Vienna, Austria

Country where clinical trial is conducted

Austria, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mRNA level of IGF-1Ea
Secondary	mRNA level of MGF, total RNA content, total protein content, ubiquitin conjugated proteins, proteasome activity