Covid19RECOVERNCT04523051
Rehabilitation After Admission in Intensive Care Unit for COVID-19
An observational study of Covid19, run by Centre Hospitalier Régional Metz-Thionville at 3 sites in France.
Trial summary
France and especially the region "Grand Est" have been severely impacted by the COVID-19 pandemic. The first affected patients gradually began leaving the hospitalization sector and some of them required rehabilitation before returning home. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19
- How many people
- 39 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Apr 2020to 1 May 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Post-COVID patient
Who may be able to join
- Post-COVID patient hospitalized in rehabilitation center
- Admission in Intensive Care Unit with proven COVID-19 disease before
Who cannot join
- Patients not willing to participate via using their medical files
Trial locations and contacts
3 sites in 1 country.
France3 sites
Etablissement de santé Filieris
Freyming-Merlebach, Moselle, 57800
Hopital Legouest
Metz, Moselle, 57000
CHR Metz Thionville
Metz, Moselle, 57085
About this study
Official title: Rehabilitation After Admission in Intensive Care Unit for COVID-19: an Observational Study
France and especially the region "Grand Est" have been severely impacted by the COVID-19 pandemic. The first affected patients gradually began leaving the hospitalization sector and some of them required rehabilitation before returning home.
Because it has only been studied for few months, COVID 19 possible impairment remain unknown, especially in patients who required admission in ICU and needed rehabilitation.
Read more
In order to better understand the impact of the disease, the investigators wish to carry out a descriptive analysis of hospitalized patient in rehabilitation center for Post-Covid-19 rehabilitation after ICU.
The purpose of this study was to describe the impairments and functional independency in patients addressed to a rehabilitation center after an ICU stay for COVID 19 and to explore the factors associated with their evolution.
- Conditions
- Covid19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Independence measure (FIM) at the admission
The FIM is an 18-item clinician-reported scale that assesses function in six areas including self-care, continence, mobility, transfers, communication and cognition. Each of the 18 items is graded on a scale of 1-7 based on level of independence in that item (1=total assistance required, 7=complete independence).
Measured: Day 1
Functional Independence measure (FIM) 1-month hospitalization
The FIM is an 18-item clinician-reported scale that assesses function in six areas including self-care, continence, mobility, transfers, communication and cognition. Each of the 18 items is graded on a scale of 1-7 based on level of independence in that item (1=total assistance required, 7=complete independence).
Measured: Day 30
Functional Independence measure (FIM) at the discharge
The FIM is an 18-item clinician-reported scale that assesses function in six areas including self-care, continence, mobility, transfers, communication and cognition. Each of the 18 items is graded on a scale of 1-7 based on level of independence in that item (1=total assistance required, 7=complete independence).
Measured: Day 180
Secondary outcomes (27)
weight at admission
weight of the patient
Measured: Day 1
weight at the discharge
weight of the patient after hospitalization
Measured: Day 180
age
age of the patient at the admission in rehabilitation center
Measured: Day 1
Estimated functional independence measure score before Covid-19
The FIM is an 18-item clinician-reported scale that assesses function in six areas including self-care, continence, mobility, transfers, communication and cognition. Each of the 18 items is graded on a scale of 1-7 based on level of independence in that item (1=total assistance required, 7=complete independence). Estimating the functional independence score before the disease.
Measured: Day 1
Estimated dyspnea symptoms before Covid-19
The modified Medical Research Council (mMRC) scale is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day on a scale from 0 to 4 (0= no breathlessness except on strenuous exercise and 4= too breathless to leave the house, or breathless when dressing or undressing).
Measured: Day 1
Length of stay in ICU unit
Length of stay in ICU unit for Covid-19
Measured: Day 1
Length of stay in acute care
Length of stay in acute care for Covid-19
Measured: Day 1
Length of stay in rehabilitation centers
Length of stay in rehabilitation centers
Measured: Day 180
Length of Invasive mechanical ventilation
Length of Invasive mechanical ventilation during the stay
Measured: Day 1
Presence of pressure ulcers
Presence of pressure ulcers, stage and localization during the management of patient
Measured: Day 180
Risk of bedsore
Risk of bedsore with the Braden scale. The Braden score consists of six subscales (sensory perception, moisture, activity, mobility, nutrition and friction/shear) representing the most commonly occuring risk factors for pressure ulcers and is scored from 6 to 23, with lower scores representing higher risk of developing pressure ulcers.
Measured: Day 1
Joint limitation
Presence of joint limitation during the management
Measured: Day 1
Dominant side
Dominant side of the patient
Measured: Day 1
Presence of psychic disorders
Presence of psychic disorders like delirium, sleep disorders, anxiety, sadness of mood, loss of appetite, suicidal thoughts, asking for psychologist care during the stay
Measured: Day 180
Muscle strength at the admission
Muscle strength examination according to Medical Research Council muscle strength scale. This scale involves testing key muscles from the upper and lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale with 0= no muscle activation and 5= muscle activation against examiner's full resistance, full range of motion.
Measured: Day 1
Muscle strength at the discharge
Muscle strength examination according to Medical Research Council muscle strength scale. This scale involves testing key muscles from the upper and lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale with 0= no muscle activation and 5= muscle activation against examiner's full resistance, full range of motion.
Measured: Day 180
Dyspnea symptoms at the admission
Dyspnea symptoms according to the modified Medical Research Council (mMRC) scale. The mMRC is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day on a scale from 0 to 4 (0= no breathlessness except on strenuous exercise and 4= too breathless to leave the house, or breathless when dressing or undressing
Measured: Day 1
Dyspnea symptoms at the discharge
Dyspnea symptoms according to the modified Medical Research Council (mMRC) scale. The mMRC is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day on a scale from 0 to 4 (0= no breathlessness except on strenuous exercise and 4= too breathless to leave the house, or breathless when dressing or undressing
Measured: Day 180
Functional exercise capacity
Functional exercise capacity measured by a 6 minutes Walking test
Measured: Day 1
Destination of patients at discharge
Destination of patients at discharge from rehabilitation center. For the destination there is 4 possibility: the return home, institutionalization, re-hospitalization or other (specify where).
Measured: Day 180
Oxygen saturation of the blood at the admission
The measuring of oxygen saturation of the blood by means of an oximeter at the admission
Measured: Day 1
Oxygen saturation of the blood at the discharge
The measuring of oxygen saturation of the blood by means of an oximeter at the discharge
Measured: Day 180
Presence of Hoffman signs
Hoffman's sign is a test to examine the reflexes of the upper extremities.
Measured: Day 180
Presence of Babinski signs
The Babinski reflex is obtained by stimulating the external portion of the sole.
Measured: Day 180
Sex
gender of participants
Measured: Day 1
Neurological examination at the admission
presence of anosmia, dysgeusia, swallowing disorders, phonation disorders, phasic disorders, confusion, headache, urinary or fecal incontinence at the admission
Measured: Day 1
Neurological examination at the discharge
presence of anosmia, dysgeusia, swallowing disorders, phonation disorders, phasic disorders, confusion, headache, urinary or fecal incontinence at the discharge
Measured: Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start1 Apr 2020
- Primary completion1 Dec 2021
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04523051
- Sponsor's protocol ID
- 2020-05Obs-CHRMT
- Acronym
- RECOVER
- Status last verified
- Sep 2022
- First submitted
- 20 Aug 2020
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation After Admission in Intensive Care Unit for COVID-19: an Observational Study
- ClinicalTrials.gov ID
- NCT04523051
- Acronym / sponsor ID
- RECOVER / 2020-05Obs-CHRMT
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 21 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.
France and especially the region "Grand Est" have been severely impacted by the COVID-19 pandemic. The first affected patients gradually began leaving the hospitalization sector and some of them required rehabilitation before returning home.
Because it has only been studied for few months, COVID 19 possible impairment remain unknown, especially in patients who required admission in ICU and needed rehabilitation.
In order to better understand the impact of the disease, the investigators wish to carry out a descriptive analysis of hospitalized patient in rehabilitation center for Post-Covid-19 rehabilitation after ICU.
The purpose of this study was to describe the impairments and functional independency in patients addressed to a rehabilitation center after an ICU stay for COVID 19 and to explore the factors associated with their evolution.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Post-COVID patient
Key inclusion criteria (2 listed)
- Post-COVID patient hospitalized in rehabilitation center
- Admission in Intensive Care Unit with proven COVID-19 disease before
Key exclusion criteria (1 listed)
- Patients not willing to participate via using their medical files
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional Independence measure (FIM) at the admission
Time frame: Day 1
The FIM is an 18-item clinician-reported scale that assesses function in six areas including self-care, continence, mobility, transfers, communication and cognition. Each of the 18 items is graded on a scale of 1-7 based on level of independence in that item (1=total assistance required, 7=complete independence).
Functional Independence measure (FIM) 1-month hospitalization
Time frame: Day 30
The FIM is an 18-item clinician-reported scale that assesses function in six areas including self-care, continence, mobility, transfers, communication and cognition. Each of the 18 items is graded on a scale of 1-7 based on level of independence in that item (1=total assistance required, 7=complete independence).
Functional Independence measure (FIM) at the discharge
Time frame: Day 180
The FIM is an 18-item clinician-reported scale that assesses function in six areas including self-care, continence, mobility, transfers, communication and cognition. Each of the 18 items is graded on a scale of 1-7 based on level of independence in that item (1=total assistance required, 7=complete independence).
27 secondary outcomes
weight at admission
Time frame: Day 1
weight at the discharge
Time frame: Day 180
age
Time frame: Day 1
Estimated functional independence measure score before Covid-19
Time frame: Day 1
Estimated dyspnea symptoms before Covid-19
Time frame: Day 1
Length of stay in ICU unit
Time frame: Day 1
Length of stay in acute care
Time frame: Day 1
Length of stay in rehabilitation centers
Time frame: Day 180
Length of Invasive mechanical ventilation
Time frame: Day 1
Presence of pressure ulcers
Time frame: Day 180
Risk of bedsore
Time frame: Day 1
Joint limitation
Time frame: Day 1
Dominant side
Time frame: Day 1
Presence of psychic disorders
Time frame: Day 180
Muscle strength at the admission
Time frame: Day 1
Muscle strength at the discharge
Time frame: Day 180
Dyspnea symptoms at the admission
Time frame: Day 1
Dyspnea symptoms at the discharge
Time frame: Day 180
Functional exercise capacity
Time frame: Day 1
Destination of patients at discharge
Time frame: Day 180
Oxygen saturation of the blood at the admission
Time frame: Day 1
Oxygen saturation of the blood at the discharge
Time frame: Day 180
Presence of Hoffman signs
Time frame: Day 180
Presence of Babinski signs
Time frame: Day 180
Sex
Time frame: Day 1
Neurological examination at the admission
Time frame: Day 1
Neurological examination at the discharge
Time frame: Day 180
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 22 Sep 2022.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Centre Hospitalier Régional Metz-Thionville at 3 sites in France.
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 1 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 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
Functional Independence measure (FIM) at the admission (time frame: Day 1). 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 22 Sep 2022.