Rehabilitation After Admission in Intensive Care Unit for COVID-19 (RECOVER)

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.

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 Overview

• Status: Completed
• Conditions: Covid19

• Study Type: Observational
• Enrollment (Actual): 39

Contacts and Locations

Study Locations

• France
  • Moselle
    • Freyming-Merlebach, Moselle, France, 57800
      • Etablissement de santé Filieris
    • Metz, Moselle, France, 57085
      • CHR Metz Thionville
    • Metz, Moselle, France, 57000
      • Hopital Legouest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Post-COVID patient

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight at admission	weight of the patient	Day 1
weight at the discharge	weight of the patient after hospitalization	Day 180
age	age of the patient at the admission in rehabilitation center	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.	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).	Day 1
Length of stay in ICU unit	Length of stay in ICU unit for Covid-19	Day 1
Length of stay in acute care	Length of stay in acute care for Covid-19	Day 1
Length of stay in rehabilitation centers	Length of stay in rehabilitation centers	Day 180
Length of Invasive mechanical ventilation	Length of Invasive mechanical ventilation during the stay	Day 1
Presence of pressure ulcers	Presence of pressure ulcers, stage and localization during the management of patient	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.	Day 1
Joint limitation	Presence of joint limitation during the management	Day 1
Dominant side	Dominant side of the patient	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	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.	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.	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	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	Day 180
Functional exercise capacity	Functional exercise capacity measured by a 6 minutes Walking test	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).	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	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	Day 180
Presence of Hoffman signs	Hoffman's sign is a test to examine the reflexes of the upper extremities.	Day 180
Presence of Babinski signs	The Babinski reflex is obtained by stimulating the external portion of the sole.	Day 180
Sex	gender of participants	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	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	Day 180

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional Metz-Thionville

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: August 20, 2020
• First Submitted That Met QC Criteria: August 20, 2020
• First Posted (Actual): August 21, 2020

Study Record Updates

• Last Update Posted (Actual): September 22, 2022
• Last Update Submitted That Met QC Criteria: September 21, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2020-05Obs-CHRMT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No