Critical IllnessNCT04503486
Relationship Between Muscle Strength and Quality of Life in ICU Survivors
An observational study of Critical Illness and Muscle Strength, run by University of Liege at 1 site in Belgium.
Trial summary
The aim is to study the impact of muscle strength measured in ICU and after ICU discharge on health-related quality of life measured after hospital discharge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Muscle Strength, Quadriceps Strength
- What is being tested?
- handgrip strength and quadriceps strength
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Aug 2020to 31 Aug 2022
- 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 patients in ICU after a stay of at least 7 days. They are included as soon as they are collaborative.
Who may be able to join
- critically ill patients with an ICU stay of at least 7 days
- collaborative
Who cannot join
- non collaborative, confusion, coma
- limb paresis or plegia
- patient refusal
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital of Liège
Liège, 4000
Anne-Françoise Rousseau, PhD, +3243667495, afrousseau@chuliege.be
About this study
Official title: Relationship Between Grip and Quadriceps Strength on Quality of Life in ICU Survivors
The aim is to study the impact of muscle strength measured in ICU and after ICU discharge on health-related quality of life measured after hospital discharge.
- Being tested
- handgrip strength, quadriceps strength
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
handgrip strengthDiagnostic test
measure of handgrip strength using Jamar Dynamometer and a standardized protocol, strength expressed in kg
quadriceps strengthDiagnostic test
maximal isometric quadriceps strength measured using a handheld dynamometer and a standardized protocol, strength expressed in Newton
What is being measured
The primary outcome is the main question the study is designed to answer.
health-related quality of life
assessed using the Sarcopenia Quality of Life (SARQOL) questionnaire short form: 8 questions with qualitative responses
Measured: 1 month after ICU discharge
health-related quality of life
assessed using the Sarcopenia Quality of Life (SARQOL) questionnaire short form: 8 questions with qualitative responses
Measured: 3 months after ICU discharge
health-related quality of life
assessed using the Sarcopenia Quality of Life (SARQOL) questionnaire short form: 8 questions with qualitative responses
Measured: 6 months after ICU discharge
health-related quality of life
assessed using the EuroQOL 5 dimensions (EQ-5D) questionnaire: a first part assess the 5 dimensions of health state (each dimension is scored from 1 to 3, 3 indicating extreme problems). A second part is visual analog scale ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine)
Measured: 1 month after ICU discharge
health-related quality of life
assessed using the EuroQOL 5 dimensions (EQ-5D) questionnaire: a first part assess the 5 dimensions of health state (each dimension is scored from 1 to 3, 3 indicating extreme problems). A second part is visual analog scale ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine)
Measured: 3 months after ICU discharge
health-related quality of life
assessed using the EuroQOL 5 dimensions (EQ-5D) questionnaire: a first part assess the 5 dimensions of health state (each dimension is scored from 1 to 3, 3 indicating extreme problems). A second part is visual analog scale ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine)
Measured: 6 months after ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start1 Aug 2020
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
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
- 100 participants (estimated)
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
- NCT04503486
- Sponsor's protocol ID
- MQV-USI
- Status last verified
- Aug 2020
- First submitted
- 1 Aug 2020
- Last updated
- 11 Aug 2020
- 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 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Grip and Quadriceps Strength on Quality of Life in ICU Survivors
- ClinicalTrials.gov ID
- NCT04503486
- Acronym / sponsor ID
- MQV-USI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 7 Aug 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.
The aim is to study the impact of muscle strength measured in ICU and after ICU discharge on health-related quality of life measured after hospital discharge.
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 patients in ICU after a stay of at least 7 days. They are included as soon as they are collaborative.
Key inclusion criteria (2 listed)
- critically ill patients with an ICU stay of at least 7 days
- collaborative
Key exclusion criteria (3 listed)
- non collaborative, confusion, coma
- limb paresis or plegia
- patient refusal
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 |
|---|---|---|
| handgrip strengthmeasure of handgrip strength using Jamar Dynamometer and a standardized protocol, strength expressed in kg | Diagnostic test | – |
| quadriceps strengthmaximal isometric quadriceps strength measured using a handheld dynamometer and a standardized protocol, strength expressed in Newton | Diagnostic test | – |
Primary outcome
health-related quality of life
Time frame: 1 month after ICU discharge
assessed using the Sarcopenia Quality of Life (SARQOL) questionnaire short form: 8 questions with qualitative responses
health-related quality of life
Time frame: 3 months after ICU discharge
assessed using the Sarcopenia Quality of Life (SARQOL) questionnaire short form: 8 questions with qualitative responses
health-related quality of life
Time frame: 6 months after ICU discharge
assessed using the Sarcopenia Quality of Life (SARQOL) questionnaire short form: 8 questions with qualitative responses
health-related quality of life
Time frame: 1 month after ICU discharge
assessed using the EuroQOL 5 dimensions (EQ-5D) questionnaire: a first part assess the 5 dimensions of health state (each dimension is scored from 1 to 3, 3 indicating extreme problems). A second part is visual analog scale ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine)
health-related quality of life
Time frame: 3 months after ICU discharge
assessed using the EuroQOL 5 dimensions (EQ-5D) questionnaire: a first part assess the 5 dimensions of health state (each dimension is scored from 1 to 3, 3 indicating extreme problems). A second part is visual analog scale ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine)
health-related quality of life
Time frame: 6 months after ICU discharge
assessed using the EuroQOL 5 dimensions (EQ-5D) questionnaire: a first part assess the 5 dimensions of health state (each dimension is scored from 1 to 3, 3 indicating extreme problems). A second part is visual analog scale ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- 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.
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 Strength, 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 3 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: status not confirmed, as of the sponsor's last update on 11 Aug 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne-Françoise Rousseau, MD, PhD (+3243667495, afrousseau@chuliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
health-related quality of life (time frame: 1 month after ICU discharge). The study lists 6 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 11 Aug 2020.