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Fatigability of the Quadriceps Muscle in Non-cooperating Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01345461
First Posted: May 2, 2011
Last Update Posted: September 29, 2017
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.
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Jesper Poulsen, Rigshospitalet, Denmark
  Purpose
As the critical care practice has improved over the last decades more patients are recovering from intensive care therapy. However, muscle atrophy and neuromuscular dysfunction are commonly observed sequelae after critical illness and are thought to play important roles in the development of intensive care unit acquired weakness (ICUAW). As a consequence, these entities may contribute to the impaired physical function and prolonged convalescence reported by ICU patients up to twelve months after discharge. Thus, strategies to counteract muscle atrophy and neuromuscular dysfunction acquired during the ICU stay may therefore potentially improve physical outcome and reduce the overall burden of critical illness. Limited information is available on muscle function in ICU patients and to our knowledge no muscle stimulation methods are currently available for evaluating muscle fatigue in large, proximal muscles groups, such as m. quadriceps, in non-cooperating ICU patients.

Condition Intervention
Muscle; Fatigue Heart Device: transcutaneous electrical muscle stimulation, (model DS7A, Digitimer, Welwyn, Garden City, Hertfordshire, UK)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fatigability of the Quadriceps Muscle in Non-cooperating Subjects

Resource links provided by NLM:


Further study details as provided by Jesper Poulsen, Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Fatigue Index (ratio) [ Time Frame: One week ]
    The tetanic stimulation period was subdivided into five intervals. For each interval the resistance to muscle fatigue was expressed as a Fatigue Index (FI) and calculated as the ratio between the sum of peak torque values from the final three contractions relative to the sum of peak torque values from the first three contractions.


Secondary Outcome Measures:
  • Slope of regression line (Nm/s) [ Time Frame: One week ]
    Peak torque values for each contraction were plotted and the slope of the regression line for each interval calculated.


Enrollment: 12
Actual Study Start Date: January 2010
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Healthy adult volunteers
Twelve healthy adult volunteers (6 men, 6 women)
Device: transcutaneous electrical muscle stimulation, (model DS7A, Digitimer, Welwyn, Garden City, Hertfordshire, UK)
two constant current high voltage stimulators delivered ten single stimuli twitches with biphasic square pulses at widths of 300 μs. A train generator was then switched on, triggering the delivery a 35 Hz current in bouts of 3 seconds periods separated by 1-second pause for a total of 40 tetanic contractions. In immediate succession to the tetanic contractions a second series of ten single twitch stimuli ended the protocol.
Other Name: Health young subjects

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
healthy adult volunteers
Criteria

Inclusion Criteria:

healthy adult volunteers

Exclusion Criteria:

medical history of cardiovascular, metabolic or neuromuscular disorders.

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01345461


Locations
Denmark
Dept. of intensive care 4131, Rigshospitalet, Copenhagen University Hospital
Copenhagen, Denmark, DK-2100 OE
Sponsors and Collaborators
Rigshospitalet, Denmark
University of Copenhagen
Investigators
Principal Investigator: Jesper B Poulsen, MD Rigshospitalet, Denmark
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jesper Poulsen, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01345461     History of Changes
Other Study ID Numbers: 25428
First Submitted: April 15, 2011
First Posted: May 2, 2011
Last Update Posted: September 29, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms