- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04284475
Relationship Between Muscle Strength and Physical Function in ICU
November 23, 2021 updated by: Anne-Françoise Rousseau, University of Liege
Analysis of the Relationship Between Muscle Strength and Physical Function in ICU Survivors
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
93
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Liège, Belgium, 4000
- University Hospital of Liege
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quadriceps strength
Time Frame: as soon as collaborative during ICU stay and up to 1 month following ICU discharge
|
Quadriceps maximal isometric strength measured using dynamometry
|
as soon as collaborative during ICU stay and up to 1 month following ICU discharge
|
Handgrip strength
Time Frame: as soon as collaborative during ICU stay and up to 1 month following ICU discharge
|
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
Time Frame: as soon as collaborative during ICU stay and up to 1 month following ICU discharge
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anne-Françoise Rousseau, MD, PhD, University Hospital of Liege
- Principal Investigator: Isabelle Kellens, PT, PhD, University Hospital of Liege
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2018
Primary Completion (Actual)
December 31, 2019
Study Completion (Actual)
November 1, 2021
Study Registration Dates
First Submitted
February 18, 2020
First Submitted That Met QC Criteria
February 22, 2020
First Posted (Actual)
February 25, 2020
Study Record Updates
Last Update Posted (Actual)
November 26, 2021
Last Update Submitted That Met QC Criteria
November 23, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MSF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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