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Investigation of the Role of FHL-1 and Myostatin in Intensive Care Unit Acquired Paresis (ICUAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01321320
Recruitment Status : Completed
First Posted : March 23, 2011
Last Update Posted : October 17, 2013
Medical Research Council
Royal Brompton & Harefield NHS Foundation Trust
Information provided by:
Imperial College London

Brief Summary:
The primary hypothesis for this study is that Myostatin and FHL-1 are important in the development of ICUAP and that changes in activity levels of muscle will modify the levels of expression and activity of these proteins.

Condition or disease Intervention/treatment Phase
Intensive Care Unit Acquired Paresis Muscle Wasting Other: Active muscle stimulation Not Applicable

Detailed Description:
ICUAP is an increasingly recognised clinical problem associated with significant morbidity and mortality. However the pathogenesis of the diseae is poorly understood and as yet no treatment exists. We believe that both myostatin and FHL-1 will be important in the development of this disease. This is based recent research and that both these proteins are likely to be regulated by sepsis and immobility (two major risk factors for ICUAP. There is evidence from invitro work that the two are likely to interact. We have designed an interventional trial to investigate the above hypothesis. Patients admitted to ICU and at risk of developing muscle wasting will be selected and receive electrical muscle stimulation of the quadriceps muscle for 1 week. Physiological measurements of peripheral and respiratory muscle strength and quadriceps size will be made pre and post intervention. And muscle biopsies, blood and urine collected from both legs pre and post intervention. The relevant molecular pathways can then be examined.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Official Title: Investigation of the Role of FHL-1 and Myostatin in the Development of Intensive Care Unit Acquired Paresis (ICUAP) and the Effect of Increased Muscle Activity on These Pathways.
Study Start Date : April 2011
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Arm Intervention/treatment
Experimental: Active stimulation
This group will receive active muscle stimulation for 1 week to the quadriceps muscle - the leg will be randomly assigned.
Other: Active muscle stimulation
Neuromuscular Electrical stimulation will be applied to one leg (randomly assigned).

Primary Outcome Measures :
  1. Change in muscle myostatin and FHL-1 [ Time Frame: 1 week ]

Secondary Outcome Measures :
  1. Change in quadriceps cross sectional area [ Time Frame: 1 week ]
  2. Change in quadriceps strength [ Time Frame: 1 week ]
  3. Change in blood myostatin, miRNA and other markers of muscle breakdown [ Time Frame: 1 week ]
  4. Changes in muscle protein synthesis and breakdown pathways as measured in the muscle biopsy samples. [ Time Frame: 1 week ]
  5. Change in muscle breakdown and synthesis pathways as a factor of amount of muscle stimulation received. [ Time Frame: 1 week ]
  6. Change in muscle phenotype and change in cross sectional area for individual fiber types [ Time Frame: 1 week ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • High risk patients admitted to AICU.

Exclusion Criteria:

  • Pre existing neuromuscular disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01321320

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United Kingdom
National Heart and Lung Institute, Imperial College
London, United Kingdom
Sponsors and Collaborators
Imperial College London
Medical Research Council
Royal Brompton & Harefield NHS Foundation Trust
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Principal Investigator: M Polkey Royal Brompton Hospital and Imperial College
Principal Investigator: Susannah Bloch Imperial College London
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Responsible Party: Prof M Polkey, Imperial College London and Royal Brompton Hospital Identifier: NCT01321320    
Other Study ID Numbers: CRO1439
First Posted: March 23, 2011    Key Record Dates
Last Update Posted: October 17, 2013
Last Verified: October 2013
Keywords provided by Imperial College London:
Critical illness
Muscle wasting
Additional relevant MeSH terms:
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Muscle Weakness
Muscular Atrophy
Wasting Syndrome
Weight Loss
Body Weight Changes
Body Weight
Metabolic Diseases
Nutrition Disorders
Neurologic Manifestations
Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Pathologic Processes
Pathological Conditions, Anatomical