NCT04284475

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2018

Typical duration for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 25, 2020

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

November 26, 2021

Status Verified

November 1, 2021

Enrollment Period

1.2 years

First QC Date

February 18, 2020

Last Update Submit

November 23, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Quadriceps strength

    Quadriceps maximal isometric strength measured using dynamometry

    as soon as collaborative during ICU stay and up to 1 month following ICU discharge

  • Handgrip strength

    Grip maximal isometric strength measured using dynamometry

    as soon as collaborative during ICU stay and up to 1 month following ICU discharge

  • 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

Interventions

Quadriceps strengthDIAGNOSTIC_TEST

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 strengthDIAGNOSTIC_TEST

Testing of dominant hand using a handgrip Measurement of the maximal isometric voluntary grip contraction Measure is expressed as kg

ICU mobility scaleDIAGNOSTIC_TEST

Scoring the physical capacity of the patient on a 10-points validated scale: the ICU mobility scale

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study includes all critical ill patients staying in ICU for at least 48 hours. They are screened as soon as they are collaborative.

You may qualify if:

  • ICU stay of at least 48h
  • Collaborative (RASS score -1 to +1)

You may not qualify if:

  • Refusal
  • Coma
  • Non collaborative
  • Hemi / tetra paresis or plegia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Liège

Liège, 4000, Belgium

Location

MeSH Terms

Conditions

Critical IllnessMuscle Weakness

Interventions

Hand Strength

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and Symptoms

Intervention Hierarchy (Ancestors)

Muscle StrengthPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Anne-Françoise Rousseau, MD, PhD

    University hospital of Liège

    PRINCIPAL INVESTIGATOR
  • Isabelle Kellens, PT, PhD

    University hospital of Liège

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Clinic, Intensive Care Dpt

Study Record Dates

First Submitted

February 18, 2020

First Posted

February 25, 2020

Study Start

October 1, 2018

Primary Completion

December 31, 2019

Study Completion

November 1, 2021

Last Updated

November 26, 2021

Record last verified: 2021-11

Locations