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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 July 28, 2014