Critical IllnessNCT04284475
Relationship Between Muscle Strength and Physical Function in ICU
An observational study of Critical Illness and Muscle Weakness, run by University of Liege at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Muscle Weakness, Physical Disability
- What is being tested?
- Quadriceps strength, Grip strength and ICU mobility scale
- How many people
- 93 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2018to 1 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ICU stay of at least 48h
- Collaborative (RASS score -1 to +1)
Who cannot join
- Refusal
- Coma
- Non collaborative
- Hemi / tetra paresis or plegia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Quadriceps strength, Grip strength, ICU mobility scale
- Medical subject headings
- Critical Illness, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps strength
Quadriceps maximal isometric strength measured using dynamometry
Measured: as soon as collaborative during ICU stay and up to 1 month following ICU discharge
Handgrip strength
Grip maximal isometric strength measured using dynamometry
Measured: 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
Measured: as soon as collaborative during ICU stay and up to 1 month following ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start1 Oct 2018
- Primary completion31 Dec 2019
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne-Françoise Rousseau, University of Liege
- Investigators
- Anne-Françoise Rousseau, MD, PhD, Principal investigator, Centre Hospitalier Universitaire de LiegeIsabelle Kellens, PT, PhD, Principal investigator, Centre Hospitalier Universitaire de Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04284475
- Sponsor's protocol ID
- MSF
- Status last verified
- Nov 2021
- First submitted
- 18 Feb 2020
- Last updated
- 26 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Relationship Between Muscle Strength and Physical Function in ICU Survivors
- ClinicalTrials.gov ID
- NCT04284475
- Acronym / sponsor ID
- MSF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 25 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- ICU stay of at least 48h
- Collaborative (RASS score -1 to +1)
Key exclusion criteria (4 listed)
- Refusal
- Coma
- Non collaborative
- Hemi / tetra paresis or plegia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quadriceps strengthUsing 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 | Diagnostic test | – |
| Grip strengthTesting of dominant hand using a handgrip Measurement of the maximal isometric voluntary grip contraction Measure is expressed as kg | Diagnostic test | – |
| ICU mobility scaleScoring the physical capacity of the patient on a 10-points validated scale: the ICU mobility scale | Diagnostic test | – |
Primary outcome
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Françoise Rousseau, MD, PhD principal investigator
Centre Hospitalier Universitaire de Liege
Isabelle Kellens, PT, PhD principal investigator
Centre Hospitalier Universitaire de Liege
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Muscle Weakness, run by University of Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quadriceps strength (time frame: as soon as collaborative during ICU stay and up to 1 month following ICU discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2021.