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Completed

NCT Number: NCT04466800

Functional and Respiratory Rehabilitation and Nutritional Care of COVID-19 Patients (RECOVER-19)

Following the acute phase of COVID, some patients may have sequelae, such as breathing difficulties or malnutrition. We hypothesize that a functional and respiratory rehabilitation program associated with personalized nutritional care will improve quality of life, physical performance and respiratory capacities and will decrease the prevalence of malnutrition among those patients.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôtel Dieu Paris, Paris, France

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About this study

In France, more than 150 000 patients have been infected by the SARS-CoV-2 virus and COVID has been responsible for more than 100 000 hospitalizations. Following the acute phase of this disease, some patients may have sequelae, such as breathing difficulties or malnutrition. However, the prevalence and intensity of those sequelae still remain unknown. Thus, a functional and respiratory rehabilitation program associated with personalized nutritional care may be necessary to improve those patients' prognosis.

This study aims to evaluate the effectiveness of a 4-week rehabilitation program following the acute phase of COVID. This program includes regular physical activity supervised by a physical acticity educator, a systematic malnutrition screening and a nutritional follow-up performed by a dietitian. Patients will be randomized in two groups: rehabilitation program (intervention group) or usual care (control group). Quality of life, physical performance, respiratory capacities and nutritional status will be assessed in both groups at inclusion and one month later (corresponding to the end of the rehabilitation program for the intervention group).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age above 18 years
  • Laboratory (RT-PCR and/or serology) confirmed infection with SARS-CoV-2
  • Date of first symptoms of SARS-CoV-2 infection > 4 weeks and < 4 months
  • Persisting functional and/or respiratory deficit and/or asthenia and/or malnutrition beyond the first 4 weeks after COVID, defined as :
  • Increase of mMRC (Modified Medical Research Council) score ≥ 1 between the month before COVID and beyond the first 4 weeks after COVID and/or
  • Asthenia score (Pichot asthenia scale) > 22 beyond the first 4 weeks after COVID, if patient had no asthenia before COVID (asthenia score <8) and/or
  • Weight loss > 5% within 6 months, comparing minimum weight between the month before COVID and beyond the first 4 weeks after COVID and/or
  • BMI (Body Mass Index) < 20 (if age < 70 years) or < 22 (if age ≥ 70 years) if BMI (Body Mass Index) ≥ 20 (if age < 70 years) or ≥ 22 (if age ≥ 70 years) the month before COVID
  • Patient affiliated to social security system
  • Patient gave written informed consent

Exclusion criteria

  • Patient unable to undergo a rehabilitation program due to comorbidities, such as major cardio-vascular disease or severe dementia
  • Patient currently benefiting from physiotherapy sessions, in particular motor and / or respiratory therapy and / or an exercise re-training and / or respiratory rehabilitation program
  • Patient living in a residential facility for dependent elderly people
  • Patient not speaking french
  • Pregnant women

Treatment and study plan

Intervention group_rehabilitation program

Other

Regular physical activity, supervised by a physical education educator, a systematic malnutrition screening and a nutritional follow-up performed by a dietetician.

Patients will follow a 4-week rehabilitation program, comprising 3 physical activity sessions per week for 4 weeks. First sessions will be supervised by a physical activity educator and patients will perform the following sessions at home, using physical training software. The physical activity educator will call patients once a week to ensure the sessions are correctly performed and adapt the program if necessary. Patients will also undergo a nutritional assessment carried out by a dietitian at the beginning of the program. A dietitian will call patients once a week to ensure their nutritional status is appropriate.

Primary outcomes

  1. Impact of a multidisciplinary and personalized rehabilitation program on COVID patients's quality of life

    Time frame: 1 month

    Physical component score of the Short-Form 36 health survey between the beginning and the end of the rehabilitation program (from 0 to 100; highers scores mean better outcome)

Secondary outcomes

  1. Impact of a multidisciplinary and personalized rehabilitation program in terms of Physical capacities

    Time frame: 1 month

    Number of repeated chair rises during 3 minutes

  2. Impact of a multidisciplinary and personalized rehabilitation program in terms of Physical capacities

    Time frame: 1 month

    Aerobic physical capacity using Eval-DM software

  3. Impact of a multidisciplinary and personalized rehabilitation program in terms of Respiratory capacities

    Time frame: 1 month

    Modified Medical Research Council scale (mMRC) (from 0 to 4, highers scores mean worse outcome)

  4. Impact of a multidisciplinary and personalized rehabilitation program in terms of Respiratory capacities

    Time frame: 3 months

    Modified Medical Research Council scale (mMRC) (from 0 to 4, highers scores mean worse outcome)

  5. Impact of a multidisciplinary and personalized rehabilitation program in terms of Respiratory capacities

    Time frame: 6 months

    Modified Medical Research Council scale (mMRC) (from 0 to 4, highers scores mean worse outcome)

  6. Impact of a multidisciplinary and personalized rehabilitation program in terms of Respiratory capacities

    Time frame: 1 month

    Borg scale (from 0 to 10, highers scores mean worse outcome)

  7. Impact of a multidisciplinary and personalized rehabilitation program in terms of Functional capacities

    Time frame: 1 month

    Barthel scale (from 0 to 100, highers scores mean worse outcome)

  8. Impact of a multidisciplinary and personalized rehabilitation program in terms of Functional capacities

    Time frame: 3 months

    Barthel scale (from 0 to 100, highers scores mean worse outcome)

  9. Impact of a multidisciplinary and personalized rehabilitation program in terms of Functional capacities

    Time frame: 6 months

    Barthel scale (from 0 to 100, highers scores mean worse outcome)

  10. Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria

    Time frame: 1 month

    Weight loss

  11. Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria

    Time frame: 3 months

    Weight loss

  12. Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria

    Time frame: 6 months

    Weight loss

  13. Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria

    Time frame: 1 month

    Body mass index

  14. Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria

    Time frame: 3 months

    Body mass index

  15. Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria

    Time frame: 6 months

    Body mass index

  16. Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria

    Time frame: 1 month

    Muscular mass by brachial circumference or grip strength

  17. Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria

    Time frame: 1 month

    SEFI® score (from 0 to 10, highers scores mean better outcome)

  18. Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria

    Time frame: 3 months

    SEFI® score (from 0 to 10, highers scores mean better outcome)

  19. Impact of a multidisciplinary and personalized rehabilitation program in terms of Malnutrition prevalence rate using GLIM malnutrition diagnostic criteria

    Time frame: 6 months

    SEFI® score (from 0 to 10, highers scores mean better outcome)

  20. Impact of a multidisciplinary and personalized rehabilitation program in terms of mortality

    Time frame: 1 month

    Mortality rate

  21. Impact of a multidisciplinary and personalized rehabilitation program in terms of mortality

    Time frame: 3 months

    Mortality rate

  22. Impact of a multidisciplinary and personalized rehabilitation program in terms of mortality

    Time frame: 6 months

    Mortality rate

  23. Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life

    Time frame: 1 month

    Score of the Short-Form 36 health Survey (from 0 to 100, highers scores mean better outcome)

  24. Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life

    Time frame: 3 months

    Score of the Short-Form 36 health Survey (from 0 to 100, highers scores mean better outcome)

  25. Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life

    Time frame: 6 months

    Score of the Short-Form 36 health Survey (from 0 to 100, highers scores mean better outcome)

  26. Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life

    Time frame: 1 month

    EuroQol 5 Dimensions 5 Levels surveys (from 0 to 1, highers scores mean better outcome)

  27. Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life

    Time frame: 3 months

    EuroQol 5 Dimensions 5 Levels surveys (from 0 to 1, highers scores mean better outcome)

  28. Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life

    Time frame: 6 months

    EuroQol 5 Dimensions 5 Levels surveys (from 0 to 1, highers scores mean better outcome)

  29. Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life

    Time frame: 1 month

    Proportion of patients returning to a professional activity

  30. Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life

    Time frame: 3 months

    Proportion of patients returning to a professional activity

  31. Impact of a multidisciplinary and personalized rehabilitation program in terms of Quality of life

    Time frame: 6 months

    Proportion of patients returning to a professional activity

  32. Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression

    Time frame: 1 month

    Hospital and Anxiety Depression Scale (from 0 to 42, highers scores mean worse outcome)

  33. Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression

    Time frame: 3 months

    Hospital and Anxiety Depression Scale (from 0 to 42, highers scores mean worse outcome

  34. Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression

    Time frame: 6 months

    Hospital and Anxiety Depression Scale (from 0 to 42, highers scores mean worse outcome

  35. Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression

    Time frame: 1 month

    Pichot asthenia scale (from 0 to 32, highers mean worse outcome)

  36. Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression

    Time frame: 3 months

    Pichot asthenia scale (from 0 to 32, highers mean worse outcome)

  37. Impact of a multidisciplinary and personalized rehabilitation program in terms of Anxiety and depression

    Time frame: 6 months

    Pichot asthenia scale (from 0 to 32, highers mean worse outcome)

  38. Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption

    Time frame: 1 month

    Number of consultations with the healthcare professionals

  39. Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption

    Time frame: 3 months

    Number of consultations with the healthcare professionals

  40. Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption

    Time frame: 6 months

    Number of consultations with the healthcare professionals

  41. Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption

    Time frame: 1 month

    Rehospitalisation rate (all causes)

  42. Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption

    Time frame: 3 months

    Rehospitalisation rate (all causes)

  43. Impact of a multidisciplinary and personalized rehabilitation program in terms of Healthcare consumption

    Time frame: 6 months

    Rehospitalisation rate (all causes)

  44. Impact of a multidisciplinary and personalized rehabilitation program in terms of Medico-economic evaluation

    Time frame: 3 months

    Incremental cost-effectiveness ratio

  45. Impact of a multidisciplinary and personalized rehabilitation program in terms of Medico-economic evaluation

    Time frame: 6 months

    Incremental cost-effectiveness ratio

  46. Patient's opinion concerning the rehabilitation program

    Time frame: 3 months

    Satisfaction questionnaire with open-ended questions (no specific scale is available)

  47. Patient's opinion concerning the rehabilitation program

    Time frame: 6 months

    Satisfaction questionnaire with open-ended questions (no specific scale is available)

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

Functional and Respiratory Rehabilitation and Nutritional Care of COVID-19 Patients

Acronym: RECOVER-19

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jul 10, 2020
Registry last updated
Jan 26, 2023

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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