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Completed

NCT Number: NCT00635440

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

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Key information

Conditions

Muscular Atrophy Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Physical Medicine and Rehabilitation, Social Medical Centre South

Vienna, State of Vienna, 1100, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. mRNA level of IGF-1Ea

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2005
First posted
Mar 13, 2008
Registry last updated
Mar 13, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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