Fatigability of the Quadriceps Muscle in Non-cooperating Subjects

NCT01345461 | Completed DMC

• 1 other identifier: 25428
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Muscle; Fatigue; Heart

Outcome Measures

Primary Outcomes (1)

• Fatigue Index (ratio)

  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.

  One week

Secondary Outcomes (1)

• Slope of regression line (Nm/s)

  One week

Study Arms (1)

Healthy adult volunteers

Twelve healthy adult volunteers (6 men, 6 women)

Device: transcutaneous electrical muscle stimulation, (model DS7A, Digitimer, Welwyn, Garden City, Hertfordshire, UK)

Interventions

transcutaneous electrical muscle stimulation, (model DS7A, Digitimer, Welwyn, Garden City, Hertfordshire, UK) DEVICE

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.

Also known as: Health young subjects

Healthy adult volunteers

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

healthy adult volunteers

You may qualify if:

• healthy adult volunteers

You may not qualify if:

• medical history of cardiovascular, metabolic or neuromuscular disorders.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• University of Copenhagen: collaborator

Study Sites (1)

Dept. of intensive care 4131, Rigshospitalet, Copenhagen University Hospital

Copenhagen, DK-2100 OE, Denmark

Location

Related Publications (1)

• Poulsen JB, Rose MH, Moller K, Perner A, Jensen BR. A Novel Noninvasive Method for Measuring Fatigability of the Quadriceps Muscle in Noncooperating Healthy Subjects. Biomed Res Int. 2015;2015:193493. doi: 10.1155/2015/193493. Epub 2015 Jul 21.

  PMID: 26266252 DERIVED

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jesper B Poulsen, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 15, 2011
• First Posted: May 2, 2011
• Study Start: January 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: June 1, 2011
• Last Updated: September 29, 2017

Record last verified: 2017-09

Locations

DK (1)