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

Study Overview
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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.

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

Conditions
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Muscular Atrophy

Intervention / Treatment
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* Device: neuromuscular electrical stimulation: Cefar-Sport (CefarCompex Scandinavia AB)
* Device: neuromuscular electrical stimulation: Cefar-Sport (CefarCompex Scandinavia AB)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Device: neuromuscular electrical stimulation: Cefar-Sport (CefarCompex Scandinavia AB)<br>* 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.<br>|
| Sham Comparator: B<br> | Device: neuromuscular electrical stimulation: Cefar-Sport (CefarCompex Scandinavia AB)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mRNA level of IGF-1Ea |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mRNA level of MGF, total RNA content, total protein content, ubiquitin conjugated proteins, proteasome activity |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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skeletal muscle, ubiquitin, proteasome, IGF-1, MGF, protein catabolism, neuromuscular electrical stimulation, Investigate effect of NMES on muscle metabolism of catabolic patients