Fatigability of the Quadriceps Muscle in Non-cooperating Subjects

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Rigshospitalet, Denmark.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Copenhagen
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01345461
First received: April 15, 2011
Last updated: April 28, 2011
Last verified: April 2011
  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 Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Fatigue Index (ratio) [ Time Frame: One week ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Peak torque values for each contraction were plotted and the slope of the regression line for each interval calculated.


Estimated Enrollment: 12
Study Start Date: January 2010
Estimated Study Completion Date: June 2011
Estimated 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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01345461

Contacts
Contact: Jesper B Poulsen, MD +4535458457 jpoulsen@dadlnet.dk

Locations
Denmark
Dept. of intensive care 4131, Rigshospitalet, Copenhagen University Hospital Recruiting
Copenhagen, Denmark, DK-2100 OE
Contact: Jesper B Poulsen, MD    +4535458457    jpoulsen@hotmail.com   
Principal Investigator: Jesper B Poulsen, MD         
Sponsors and Collaborators
Rigshospitalet, Denmark
University of Copenhagen
Investigators
Principal Investigator: Jesper B Poulsen, MD Rigshospitalet, Denmark
  More Information

No publications provided

Responsible Party: Jesper Brøndum Poulsen, MD,, Rigshospitalet, University Hospital of Copenhagen
ClinicalTrials.gov Identifier: NCT01345461     History of Changes
Other Study ID Numbers: 25428
Study First Received: April 15, 2011
Last Updated: April 28, 2011
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

ClinicalTrials.gov processed this record on September 18, 2014