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

Primary Purpose

Muscular Atrophy

Status

Completed

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

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

About this trial

This is an interventional basic science trial for Muscular Atrophy focused on measuring skeletal muscle, ubiquitin, proteasome, IGF-1, MGF, protein catabolism, neuromuscular electrical stimulation, Investigate effect of NMES on muscle metabolism of catabolic patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Institute of Physical Medicine and Rehabilitation, Social Medical Centre South

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Arm Description

Outcomes

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

Full Information

NCT ID

NCT00635440

First Posted

February 25, 2008

Last Updated

March 12, 2008

Sponsor

Medical University of Vienna

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00635440

Brief Title

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

2. Study Status

Record Verification Date

March 2008

Overall Recruitment Status

Completed

Study Start Date

December 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Medical University of Vienna

Collaborators

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

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Sham Comparator

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

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

Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

mRNA level of IGF-1Ea

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Quittan, PhD, MD

Organizational Affiliation

Institute of Physical Medicine and Rehabilitation, Social Medical Centre South

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institute of Physical Medicine and Rehabilitation, Social Medical Centre South

City

Vienna

ZIP/Postal Code

1100

Country

Austria

12. IPD Sharing Statement

Citations:

PubMed Identifier

8280075

Citation

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Results Reference

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PubMed Identifier

12594312

Citation

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Results Reference

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PubMed Identifier

15131238

Citation

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.

Results Reference

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PubMed Identifier

2372054

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. doi: 10.1152/ajpendo.1990.259.1.E89.

Results Reference

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PubMed Identifier

12562960

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

Results Reference

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PubMed Identifier

11679633

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

Results Reference

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PubMed Identifier

11237275

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.

Results Reference

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PubMed Identifier

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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.

Results Reference

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

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