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Completed

NCT Number: NCT04523051

Rehabilitation After Admission in Intensive Care Unit for COVID-19

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Etablissement de santé Filieris, Freyming-Merlebach, Moselle, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

Secondary outcomes

  1. weight at admission

    Time frame: Day 1

    weight of the patient

  2. weight at the discharge

    Time frame: Day 180

    weight of the patient after hospitalization

  3. age

    Time frame: Day 1

    age of the patient at the admission in rehabilitation center

  4. Estimated functional independence measure score before Covid-19

    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). Estimating the functional independence score before the disease.

  5. Estimated dyspnea symptoms before Covid-19

    Time frame: Day 1

    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).

  6. Length of stay in ICU unit

    Time frame: Day 1

    Length of stay in ICU unit for Covid-19

  7. Length of stay in acute care

    Time frame: Day 1

    Length of stay in acute care for Covid-19

  8. Length of stay in rehabilitation centers

    Time frame: Day 180

    Length of stay in rehabilitation centers

  9. Length of Invasive mechanical ventilation

    Time frame: Day 1

    Length of Invasive mechanical ventilation during the stay

  10. Presence of pressure ulcers

    Time frame: Day 180

    Presence of pressure ulcers, stage and localization during the management of patient

  11. Risk of bedsore

    Time frame: Day 1

    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.

  12. Joint limitation

    Time frame: Day 1

    Presence of joint limitation during the management

  13. Dominant side

    Time frame: Day 1

    Dominant side of the patient

  14. Presence of psychic disorders

    Time frame: Day 180

    Presence of psychic disorders like delirium, sleep disorders, anxiety, sadness of mood, loss of appetite, suicidal thoughts, asking for psychologist care during the stay

  15. Muscle strength at the admission

    Time frame: Day 1

    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.

  16. Muscle strength at the discharge

    Time frame: Day 180

    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.

  17. Dyspnea symptoms at the admission

    Time frame: Day 1

    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

  18. Dyspnea symptoms at the discharge

    Time frame: Day 180

    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

  19. Functional exercise capacity

    Time frame: Day 1

    Functional exercise capacity measured by a 6 minutes Walking test

  20. Destination of patients at discharge

    Time frame: Day 180

    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).

  21. Oxygen saturation of the blood at the admission

    Time frame: Day 1

    The measuring of oxygen saturation of the blood by means of an oximeter at the admission

  22. Oxygen saturation of the blood at the discharge

    Time frame: Day 180

    The measuring of oxygen saturation of the blood by means of an oximeter at the discharge

  23. Presence of Hoffman signs

    Time frame: Day 180

    Hoffman's sign is a test to examine the reflexes of the upper extremities.

  24. Presence of Babinski signs

    Time frame: Day 180

    The Babinski reflex is obtained by stimulating the external portion of the sole.

  25. Sex

    Time frame: Day 1

    gender of participants

  26. Neurological examination at the admission

    Time frame: Day 1

    presence of anosmia, dysgeusia, swallowing disorders, phonation disorders, phasic disorders, confusion, headache, urinary or fecal incontinence at the admission

  27. Neurological examination at the discharge

    Time frame: Day 180

    presence of anosmia, dysgeusia, swallowing disorders, phonation disorders, phasic disorders, confusion, headache, urinary or fecal incontinence at the discharge

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional Metz-Thionville

Other

Registry information

Official study title

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

Acronym: RECOVER

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Aug 21, 2020
Registry last updated
Sep 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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