Critically IllNCT03922113
Muscle Function After Intensive Care
An observational study of Critically Ill and Colorectal Surgery, run by University of Liege.
Trial summary
Final objective of critical care is no longer only survival. The role of medical and paramedical teams should also be to restore functional capacities, autonomy and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Critically Ill, Colorectal Surgery, Healthy
- What is being tested?
- Patient follow up
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2015to 30 Apr 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Collaborative ICU patients with length of stay > 48h * Surgical patients scheduled for colorectal surgery * Healthy subjects
Who may be able to join
- Collaborative ICU patients with length of stay > 48h
- Surgical patients scheduled for colorectal surgery
- Healthy subjects
Who cannot join
- a score > 1 or < -1 on the Richmond Agitation and Sedation Scale (RASS)
- coma
- total hip or knee arthroplasty in the dominant limb
- unauthorized support on the dominant leg
- open wound located at the ankle's anterior face of the dominant leg
- pre-existing myopathy or polyneuropathy
- para- or tetraparesis, para- or tetraplegia
- refusal.
About this study
Official title: Muscle Strength and Function After Intensive Care, Compared to Surgical and Healthy Subjects
Final objective of critical care is no longer only survival. The role of medical and paramedical teams should also be to restore functional capacities, autonomy and quality of life. What has been call "intensive care unit - acquired weakness" (ICU-AW) is associated to acute and long term increased mortality, prolonged ICU and hospital stay, prolonged duration of mechanical ventilation, altered quality of life in survivors and increased health-related costs. In order to target efficient secondary prevention and early rehabilitation, prompt identification of muscle weakness is crucial. Several methods, aiming to assess muscle mass, muscle strength or physical function, are described. Manual muscle testing using the Medical Research Council (MRC) scale is still the most commonly utilized tool to diagnose ICU-AW (MRC <48/60). Dynamometry is an objective alternative and one of the most accurate clinimetric tool to assess muscle strength. Literature is overflowing with insufficiently standardized dynamometry data. Using the investigator's published standardized protocol of quadriceps strength (QS) assessment, this observational study aim to describe physical performances of CC patients and thus to define the weakest ones, by comparing them to surgical and healthy subjects.
- Conditions
- Critically Ill, Colorectal Surgery, Healthy, Muscle Strength
- Being tested
- Patient follow up
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient follow upOther
Patient follow up during one month
| Study group | Role | What they receive |
|---|---|---|
| Critically ill patients | Patients who spent a minimum of 48h in ICU Receives: Other: Patient follow up | |
| Surgical patients | Patients who were scheduled for elective colorectal surgery Receives: Other: Patient follow up | |
| Healthy subjects | Healthy volunteers Receives: Other: Patient follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quadriceps strength
Maximal isometric voluntary quadriceps contraction is assessed using a hand-held dynamometer (MicroFet2®, Hoggan Health Industries, West Jordan, UT, USA) with a curved transducer pad. The highly standardized protocol is detailed in a previously published validation study (Rousseau et al, Acta Anaesthesiologica Belgica 2018). Measurements are performed at bedside with patient lying on supine position. The dominant limb is tested (kicking leg). The best performance out of 3 measurements is considered for the analysis. Muscle strength is expressed in Newton (N). Relative strength, normalized according to actual body weight, is expressed in N/kg.
Measured: For critically ill patients: T0 (as soon as they were collaborative in ICU) and M1 (at one month following discharge), for surgical patients at T0 (day before surgery) and at M1 (one month following discharge), for healthy subjects: T0
Secondary outcomes (3)
Change in Medical Research Council test (MRC)
Manual evaluation of muscle strength. This scale grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle. Grade 0 = no movement is observed, grade 5= muscle contracts normally against full resistance. Six muscles groups are tested at both sides of the body: shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, ankle dorsiflexion. Maximal total score is 60.
Measured: For critically ill patients: T0 (as soon as they were collaborative in ICU) and M1 (at one month following discharge), for surgical patients at T0 (day before surgery) and at M1 (one month following discharge), for healthy subjects: T0
Change in 4-items Physical Function Intensive care Test (PFIT-s)
This test measures strength and functional outcomes, by ranking 4 components: assistance (sit and stand), cadence (steps/min), shoulder flexion strength and knee extension strength. Maximal score is 10.
Measured: For critically ill patients: T0 (as soon as they were collaborative in ICU) and M1 (at one month following discharge), for surgical patients at T0 (day before surgery) and at M1 (one month following discharge), for healthy subjects: T0
Change in Barthel index for activities of daily living
This score assesses functional independence by ranking patient's independence in the following areas: feeding, bathing, grooming, dressing, bowel control, bladder control, toilet use, transfers, mobility in level surfaces and stairs. Maximal total score is 100 = totally independent).
Measured: For critically ill patients: T0 (as soon as they were collaborative in ICU) and M1 (at one month following discharge), for surgical patients at T0 (day before surgery) and at M1 (one month following discharge), for healthy subjects: T0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start1 Sep 2015
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically IllStudies 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
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rousseau, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03922113
- Sponsor's protocol ID
- FAIC
- Status last verified
- Apr 2019
- First submitted
- 13 Apr 2019
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Strength and Function After Intensive Care, Compared to Surgical and Healthy Subjects
- ClinicalTrials.gov ID
- NCT03922113
- Acronym / sponsor ID
- FAIC
- Conditions
- Critically Ill, Colorectal Surgery, Healthy, Muscle Strength
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 19 Apr 2019 (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.
Final objective of critical care is no longer only survival. The role of medical and paramedical teams should also be to restore functional capacities, autonomy and quality of life. What has been call "intensive care unit - acquired weakness" (ICU-AW) is associated to acute and long term increased mortality, prolonged ICU and hospital stay, prolonged duration of mechanical ventilation, altered quality of life in survivors and increased health-related costs. In order to target efficient secondary prevention and early rehabilitation, prompt identification of muscle weakness is crucial. Several methods, aiming to assess muscle mass, muscle strength or physical function, are described. Manual muscle testing using the Medical Research Council (MRC) scale is still the most commonly utilized tool to diagnose ICU-AW (MRC <48/60). Dynamometry is an objective alternative and one of the most accurate clinimetric tool to assess muscle strength. Literature is overflowing with insufficiently standardized dynamometry data. Using the investigator's published standardized protocol of quadriceps strength (QS) assessment, this observational study aim to describe physical performances of CC patients and thus to define the weakest ones, by comparing them to surgical and healthy subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Critically ill patients | – | Other: Patient follow upPatients who spent a minimum of 48h in ICU |
| Surgical patients | – | Other: Patient follow upPatients who were scheduled for elective colorectal surgery |
| Healthy subjects | – | Other: Patient follow upHealthy volunteers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Collaborative ICU patients with length of stay > 48h * Surgical patients scheduled for colorectal surgery * Healthy subjects
Key inclusion criteria (3 listed)
- Collaborative ICU patients with length of stay > 48h
- Surgical patients scheduled for colorectal surgery
- Healthy subjects
Key exclusion criteria (8 listed)
- a score > 1 or < -1 on the Richmond Agitation and Sedation Scale (RASS)
- coma
- total hip or knee arthroplasty in the dominant limb
- unauthorized support on the dominant leg
- open wound located at the ankle's anterior face of the dominant leg
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 |
|---|---|---|
| Patient follow upPatient follow up during one month | Other | Critically ill patients, Healthy subjects, Surgical patients |
Primary outcome
Change in Quadriceps strength
Time frame: For critically ill patients: T0 (as soon as they were collaborative in ICU) and M1 (at one month following discharge), for surgical patients at T0 (day before surgery) and at M1 (one month following discharge), for healthy subjects: T0
Maximal isometric voluntary quadriceps contraction is assessed using a hand-held dynamometer (MicroFet2®, Hoggan Health Industries, West Jordan, UT, USA) with a curved transducer pad. The highly standardized protocol is detailed in a previously published validation study (Rousseau et al, Acta Anaesthesiologica Belgica 2018). Measurements are performed at bedside with patient lying on supine position. The dominant limb is tested (kicking leg). The best performance out of 3 measurements is considered for the analysis. Muscle strength is expressed in Newton (N). Relative strength, normalized according to actual body weight, is expressed in N/kg.
3 secondary outcomes
Change in Medical Research Council test (MRC)
Time frame: For critically ill patients: T0 (as soon as they were collaborative in ICU) and M1 (at one month following discharge), for surgical patients at T0 (day before surgery) and at M1 (one month following discharge), for healthy subjects: T0
Change in 4-items Physical Function Intensive care Test (PFIT-s)
Time frame: For critically ill patients: T0 (as soon as they were collaborative in ICU) and M1 (at one month following discharge), for surgical patients at T0 (day before surgery) and at M1 (one month following discharge), for healthy subjects: T0
Change in Barthel index for activities of daily living
Time frame: For critically ill patients: T0 (as soon as they were collaborative in ICU) and M1 (at one month following discharge), for surgical patients at T0 (day before surgery) and at M1 (one month following discharge), for healthy subjects: T0
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 19 Apr 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Critically Ill and Colorectal Surgery, run by University of Liege.
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 3 inclusion and 8 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 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in Quadriceps strength (time frame: For critically ill patients: T0 (as soon as they were collaborative in ICU) and M1 (at one month following discharge), for surgical patients at T0 (day before surgery) and at M1 (one month following discharge), for healthy subjects: T0). 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 19 Apr 2019.