Rehabilitation After Admission in Intensive Care Unit for COVID-19

Covid19 Clinical Trial

— RECOVER  

Official title:

Rehabilitation After Admission in Intensive Care Unit for COVID-19: an Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04523051
• Other study ID #: 2020-05Obs-CHRMT
• Status: Completed
• Start date: April 1, 2020
• Est. completion date: May 1, 2022

Study information

• Verified date: September 2022
• Source: Centre Hospitalier Régional Metz-Thionville
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: May 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Post-COVID patient hospitalized in rehabilitation center

• Admission in Intensive Care Unit with proven COVID-19 disease before

Exclusion Criteria:

• Patients not willing to participate via using their medical files

Related Conditions & MeSH terms

• COVID-19
• Covid19

Locations

Country	Name	City	State
France	Etablissement de santé Filieris	Freyming-Merlebach	Moselle
France	CHR Metz Thionville	Metz	Moselle
France	Hopital Legouest	Metz	Moselle

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional Metz-Thionville

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Day 1
Primary	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).	Day 30
Primary	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).	Day 180
Secondary	weight at admission	weight of the patient	Day 1
Secondary	weight at the discharge	weight of the patient after hospitalization	Day 180
Secondary	age	age of the patient at the admission in rehabilitation center	Day 1
Secondary	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.	Day 1
Secondary	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).	Day 1
Secondary	Length of stay in ICU unit	Length of stay in ICU unit for Covid-19	Day 1
Secondary	Length of stay in acute care	Length of stay in acute care for Covid-19	Day 1
Secondary	Length of stay in rehabilitation centers	Length of stay in rehabilitation centers	Day 180
Secondary	Length of Invasive mechanical ventilation	Length of Invasive mechanical ventilation during the stay	Day 1
Secondary	Presence of pressure ulcers	Presence of pressure ulcers, stage and localization during the management of patient	Day 180
Secondary	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.	Day 1
Secondary	Joint limitation	Presence of joint limitation during the management	Day 1
Secondary	Dominant side	Dominant side of the patient	Day 1
Secondary	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	Day 180
Secondary	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.	Day 1
Secondary	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.	Day 180
Secondary	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	Day 1
Secondary	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	Day 180
Secondary	Functional exercise capacity	Functional exercise capacity measured by a 6 minutes Walking test	Day 1
Secondary	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).	Day 180
Secondary	Oxygen saturation of the blood at the admission	The measuring of oxygen saturation of the blood by means of an oximeter at the admission	Day 1
Secondary	Oxygen saturation of the blood at the discharge	The measuring of oxygen saturation of the blood by means of an oximeter at the discharge	Day 180
Secondary	Presence of Hoffman signs	Hoffman's sign is a test to examine the reflexes of the upper extremities.	Day 180
Secondary	Presence of Babinski signs	The Babinski reflex is obtained by stimulating the external portion of the sole.	Day 180
Secondary	Sex	gender of participants	Day 1
Secondary	Neurological examination at the admission	presence of anosmia, dysgeusia, swallowing disorders, phonation disorders, phasic disorders, confusion, headache, urinary or fecal incontinence at the admission	Day 1
Secondary	Neurological examination at the discharge	presence of anosmia, dysgeusia, swallowing disorders, phonation disorders, phasic disorders, confusion, headache, urinary or fecal incontinence at the discharge	Day 180