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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04284475
Other study ID # MSF
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2018
Est. completion date November 1, 2021

Study information

Verified date November 2021
Source University of Liege
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This observational study aims to assess the relationship between muscle strength and physical function in critical ill patients. Grip and quadriceps strengths are measured using a standardized protocol of dynamometry. Physical function is assessed using the validated ICU mobility scale.


Recruitment information / eligibility

Status Completed
Enrollment 93
Est. completion date November 1, 2021
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - ICU stay of at least 48h - Collaborative (RASS score -1 to +1) Exclusion Criteria: - Refusal - Coma - Non collaborative - Hemi / tetra paresis or plegia

Study Design


Intervention

Diagnostic Test:
Quadriceps strength
Using a handheld dynamometer, in supine position in a standardized position of the dominant leg Measurement of the maximal isometric voluntary quadriceps contraction Measure expressed as Newton and Newton/kg
Grip strength
Testing of dominant hand using a handgrip Measurement of the maximal isometric voluntary grip contraction Measure is expressed as kg
ICU mobility scale
Scoring the physical capacity of the patient on a 10-points validated scale: the ICU mobility scale

Locations

Country Name City State
Belgium University Hospital of Liège Liège

Sponsors (1)

Lead Sponsor Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quadriceps strength Quadriceps maximal isometric strength measured using dynamometry as soon as collaborative during ICU stay and up to 1 month following ICU discharge
Primary Handgrip strength Grip maximal isometric strength measured using dynamometry as soon as collaborative during ICU stay and up to 1 month following ICU discharge
Primary ICU mobility scale Ranking the patient on the scale according to his/her physical capacity. ICU mobility scale is a 10 points scale: 0 means the patient is lying in bed, 10 means the patient is able to walk independently as soon as collaborative during ICU stay and up to 1 month following ICU discharge
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