Muscular AtrophyNCT00635440
Randomized, Controlled Study to Investigate the Effect of Neuromuscular Electrical Stimulation (NMES) on Muscle Metabolism of Abdominal Surgical Patients
A study testing neuromuscular electrical stimulation: Cefar-Sport (CefarCompex Scandinavia AB) in people with Muscular Atrophy, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscular Atrophy
- What is being tested?
- neuromuscular electrical stimulation: Cefar-Sport (CefarCompex Scandinavia AB)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteAustria
- Study dates
- Dec 2005to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- intended for major abdominal surgery
- more than 18 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Institute of Physical Medicine and Rehabilitation, Social Medical Centre South
Vienna, State of Vienna, 1100
About this study
Official title: 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.
- Conditions
- Muscular Atrophy
- Being tested
- neuromuscular electrical stimulation: Cefar-Sport (CefarCompex Scandinavia AB)
- Keywords
- skeletal muscle, ubiquitin, proteasome, IGF-1, MGF, protein catabolism, neuromuscular electrical stimulation, Investigate effect of NMES on muscle metabolism of catabolic patients
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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. Current was increased until the patient could feel a tingling sensation but no muscle contraction was visible or palpable.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Device: neuromuscular electrical stimulation: Cefar-Sport (CefarCompex Scandinavia AB) |
| B | Sham comparator | Not described Receives: Device: neuromuscular electrical stimulation: Cefar-Sport (CefarCompex Scandinavia AB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
mRNA level of IGF-1Ea
Secondary outcomes (1)
mRNA level of MGF, total RNA content, total protein content, ubiquitin conjugated proteins, proteasome activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Muscular AtrophyStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Surgery, Social Medical Centre South, Vienna, Austria, Institute for Pathology and Microbiology, Social Medical Centre South, Vienna, Austria
- Investigators
- Michael Quittan, PhD, MD, Principal investigator, Institute of Physical Medicine and Rehabilitation, Social Medical Centre South
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635440
- Sponsor's protocol ID
- Muscle-2446
- Status last verified
- Mar 2008
- First submitted
- 25 Feb 2008
- Last updated
- 13 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Roth E, Valentini L, Holzenbein T, Winkler S, Sautner T, Hortnagl H, Karner J. Acute effects of insulin-like growth factor I on inter-organ amino acid flux in protein-catabolic dogs. Biochem J. 1993 Dec 15;296 ( Pt 3)(Pt 3):765-9. doi: 10.1042/bj2960765.
PubMed 8280075Herridge MS, Cheung AM, Tansey CM, Matte-Martyn A, Diaz-Granados N, Al-Saidi F, Cooper AB, Guest CB, Mazer CD, Mehta S, Stewart TE, Barr A, Cook D, Slutsky AS; Canadian Critical Care Trials Group. One-year outcomes in survivors of the acute respiratory distress syndrome. N Engl J Med. 2003 Feb 20;348(8):683-93. doi: 10.1056/NEJMoa022450.
PubMed 12594312Biolo 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.
PubMed 15131238DeVol 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.
PubMed 2372054Hameed 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.
PubMed 12562960Bodine 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.
PubMed 11679633Quittan 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.
PubMed 11237275Strasser 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.
PubMed 19387331
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Neuromuscular Electrical Stimulation on Muscle Metabolism of Major Abdominal Surgical Patients
- ClinicalTrials.gov ID
- NCT00635440
- Acronym / sponsor ID
- Muscle-2446
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Department of Surgery, Social Medical Centre South, Vienna, Austria, Institute for Pathology and Microbiology, Social Medical Centre South, Vienna, Austria
- Study start
- Dec 2005
- First posted
- 13 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Device: neuromuscular electrical stimulation: Cefar-Sport (CefarCompex Scandinavia AB) |
| B | Sham comparator | Device: neuromuscular electrical stimulation: Cefar-Sport (CefarCompex Scandinavia AB) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- intended for major abdominal surgery
- more than 18 years old
Key exclusion criteria (6 listed)
- neuromuscular diseases
- immobility before surgery
- arterial occlusive disease Fontaine stadium IV
- clinical or laboratory signs of inflammation or sepsis
- cachexia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | A |
| 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. | Device | B |
Primary outcome
mRNA level of IGF-1Ea
1 secondary outcome
mRNA level of MGF, total RNA content, total protein content, ubiquitin conjugated proteins, proteasome activity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2008.
- Background: PubMed 8280075Roth E, Valentini L, Holzenbein T, Winkler S, Sautner T, Hortnagl H, Karner J. Acute effects of insulin-like growth factor I on inter-organ amino acid flux in protein-catabolic dogs. Biochem J. 1993 Dec 15;296 ( Pt 3)(Pt 3):765-9. doi: 10.1042/bj2960765.
- Background: PubMed 12594312Herridge MS, Cheung AM, Tansey CM, Matte-Martyn A, Diaz-Granados N, Al-Saidi F, Cooper AB, Guest CB, Mazer CD, Mehta S, Stewart TE, Barr A, Cook D, Slutsky AS; Canadian Critical Care Trials Group. One-year outcomes in survivors of the acute respiratory distress syndrome. N Engl J Med. 2003 Feb 20;348(8):683-93. doi: 10.1056/NEJMoa022450.
- Background: PubMed 15131238Biolo 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.
- Background: PubMed 2372054DeVol 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.
- Background: PubMed 12562960Hameed 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.
- Background: PubMed 11679633Bodine 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.
- Background: PubMed 11237275Quittan 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.
- Derived from this study: PubMed 19387331Strasser 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Quittan, PhD, MD principal investigator
Institute of Physical Medicine and Rehabilitation, Social Medical Centre South
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neuromuscular electrical stimulation: Cefar-Sport (CefarCompex Scandinavia AB) in people with Muscular Atrophy, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mRNA level of IGF-1Ea. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00635440, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2008.