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

February 25, 2008
March 12, 2008
December 2005
Not Provided
mRNA level of IGF-1Ea
Same as current
Complete list of historical versions of study NCT00635440 on ClinicalTrials.gov Archive Site
mRNA level of MGF, total RNA content, total protein content, ubiquitin conjugated proteins, proteasome activity
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
Muscular Atrophy
  • 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.
  • 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.
  • Active Comparator: A
    Intervention: Device: neuromuscular electrical stimulation: Cefar-Sport (CefarCompex Scandinavia AB)
  • Sham Comparator: B
    Intervention: Device: neuromuscular electrical stimulation: Cefar-Sport (CefarCompex Scandinavia AB)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
Not Provided
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00635440
Muscle-2446
No
Institute of Physical Medicine and Rehabilitation, Social Medical Centre South, Vienna
Medical University of Vienna
  • Department of Surgery, Social Medical Centre South, Vienna, Austria
  • Institute for Pathology and Microbiology, Social Medical Centre South, Vienna, Austria
Principal Investigator: Michael Quittan, PhD, MD Institute of Physical Medicine and Rehabilitation, Social Medical Centre South
Medical University of Vienna
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP