NCT01364714

Brief Summary

Intensive care unit (ICU) admission is associated with muscle weakness and ICU survivors report persevering limitation of physical capacity for years after discharge. Limited information is available about the underlying biomechanical properties responsible for this muscle function impairment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 2, 2011

Completed
Last Updated

September 29, 2017

Status Verified

September 1, 2017

Enrollment Period

1.1 years

First QC Date

May 31, 2011

Last Update Submit

September 27, 2017

Conditions

Keywords

ICU acquired weakness

Study Arms (2)

ICU survivors

Male ICU survivors 12 month after discharge

Controls

Age and gender matched controls

Eligibility Criteria

Age50 Years - 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

ICU survivors 12 months after discharge compared to age and gender matched controls

You may qualify if:

  • ICU length of stay \> 72 hours
  • Informed consent

You may not qualify if:

  • BMI\>30
  • Neuromuscular or psychiatric disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biomechanics and Motor Control Laboratory, Department of Exercise and Sport Sciences, University of Copenhagen

Copenhagen, DK-2100 OE, Denmark

Location

MeSH Terms

Conditions

Muscular Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesNeuromuscular DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 31, 2011

First Posted

June 2, 2011

Study Start

January 1, 2010

Primary Completion

February 1, 2011

Study Completion

March 1, 2011

Last Updated

September 29, 2017

Record last verified: 2017-09

Locations