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

NCT ID: NCT00635440

Last Updated: 2008-03-13

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Muscular Atrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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A

Group Type ACTIVE_COMPARATOR

neuromuscular electrical stimulation: Cefar-Sport (CefarCompex Scandinavia AB)

Intervention Type DEVICE

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.

B

Group Type SHAM_COMPARATOR

neuromuscular electrical stimulation: Cefar-Sport (CefarCompex Scandinavia AB)

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

UNKNOWN

Sponsor Role collaborator

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

UNKNOWN

Sponsor Role collaborator

Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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

Principal Investigators

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Michael Quittan, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Physical Medicine and Rehabilitation, Social Medical Centre South

Locations

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Institute of Physical Medicine and Rehabilitation, Social Medical Centre South

Vienna, Vienna, Austria

Site Status

Countries

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Austria

References

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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.

Reference Type BACKGROUND
PMID: 8280075 (View on PubMed)

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. doi: 10.1056/NEJMoa022450.

Reference Type BACKGROUND
PMID: 12594312 (View on PubMed)

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. doi: 10.1113/jphysiol.2004.066365. Epub 2004 May 6.

Reference Type BACKGROUND
PMID: 15131238 (View on PubMed)

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. doi: 10.1152/ajpendo.1990.259.1.E89.

Reference Type BACKGROUND
PMID: 2372054 (View on PubMed)

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. doi: 10.1113/jphysiol.2002.032136. Epub 2002 Dec 20.

Reference Type BACKGROUND
PMID: 12562960 (View on PubMed)

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. doi: 10.1126/science.1065874. Epub 2001 Oct 25.

Reference Type BACKGROUND
PMID: 11679633 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11237275 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19387331 (View on PubMed)

Other Identifiers

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Muscle-2446

Identifier Type: -

Identifier Source: org_study_id

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