Rehabilitation for People With COVID-19 in ICU
Keywords
Abstract
Description
People that develop ARDS due to COVID-19 and requiring admission to ICU (both invasive and non-invasive mechanical ventilation) will be enrolled. Two tertiary referral centers, part of the same region (Veneto) but located in different cities, will recruit participants. ICU standard of care is the same as defined by regional and national guidelines; rehabilitation in ICU COVID-19 subjects is provided only in one center due to local technical and organizational limitations. Non contamination between centers is possible due to restrictions of mobility and strict admission criteria based on catchment area.
Early physiotherapy treatment will start from the day of admission. Baseline measurement of physical function will performed using the Physical Function in ICU Test (PFIT). The PFIT is a submaximal exercise test that was developed for patients in the ICU who may not be able to mobilize away from the bedside.
Participants will start rehabilitation if they will not experiment one of the following conditions or should cease exercise because of the following (see exclusion criteria).
Rehabilitation Intervention
Rehabilitation program will start at admission in ICU. The program is based on the clinical characteristics of the individual to be treated. Participants will commence a hierarchical, standardized protocol that includes functional, respiratory and strength training. If participants will be unable to sit out of bed, assisted active exercises will be performed in bed. Exercise training will be provided for 15 minutes 3 times/day, 6 days per week.
Intensity of strength training: Until fatigue (Borg Scale) Type of strength training: >Grade 3 Medical Research Council (MRC) strength, active to resisted; Motor program - Intubated patient Glasgow Coma Scale (GCS) >8: passive mobilisation; postural positioning Glasgow Coma Scale < 8 (weaning): passive and active-assist mobilisation; postural positioning - Weaned off patient Non-invasively ventilated/O2 high fluxes - If strength < 3 MRC: passive and/or active-assist; tentative functional retraining - If strength ≥3 MRC: active-assist and active; strength training; functional retraining Pulmonary Rehabilitation - Intubated patient Glasgow Coma Scale >8: postural positioning Glasgow Coma Scale < 8 (weaning): postural positioning, cautious inspiratory muscle training - Weaned off patient Non-invasively ventilated/O2 high fluxes - If strength < 3 MRC: postural positioning, positive pressure expiration exercise, cautious inspiratory muscle training - If strength ≥3 MRC: postural positioning, positive pressure expiration exercise, inspiratory muscle training The intensity of exercise will prescribed based on the results of the PFIT. Rehabilitation programs will individualized for each patient. Programs will progressed using rates of perceived exertion (RPE) of the modified Borg Scale. Total session time composition:15 min to complete: - Whole-body bed exercises + strength + functional retraining - respiratory rehabilitation Frequency of sessions: 3×15 min/day
Dates
| Last Verified: | 04/30/2020 |
| First Submitted: | 05/03/2020 |
| Estimated Enrollment Submitted: | 05/06/2020 |
| First Posted: | 05/07/2020 |
| Last Update Submitted: | 05/06/2020 |
| Last Update Posted: | 05/07/2020 |
| Actual Study Start Date: | 05/09/2020 |
| Estimated Primary Completion Date: | 09/29/2020 |
| Estimated Study Completion Date: | 09/29/2020 |
Condition or disease
Intervention/treatment
Other: Rehabilitation in COVID-19 patients in ICU
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Rehabilitation in COVID-19 patients in ICU Every person admitted to ICU for ARDS with a confirmed diagnosis of COVID-19 Motor program
Intubated patient GCS >8: passive mobilization; postural positioning GCS< 8: passive and active-assist mobilization; postural positioning
Extubated patient
If strength < 3 MRC: passive and/or active-assist; functional retraining
If strength ≥3 MRC: active-assist and active; strength training; functional retraining Pulmonary Rehabilitation
Intubated patient GCS >8: postural positioning GCS< 8: postural positioning, cautious inspiratory muscle training
Extubated patient
If strength < 3 MRC: postural positioning, positive pressure expiration exercise,inspiratory muscle training
If strength ≥3 MRC: postural positioning, positive pressure expiration exercise, inspiratory muscle training The intensity of exercise will prescribed based on the results of the PFIT. and modified Borg Scale.
Frequency of sessions: 3×15 min/day | Other: Rehabilitation in COVID-19 patients in ICU Pulmonary and Motor Rehabilitation in ICU |
| No Intervention: COVID-19 in ICU without Rehabilitation Standard of care without rehabilitation in ICU |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - Confirmed COVID-19 diagnosis, admitted to ICU with ARDS Exclusion Criteria: - Neuromuscular disease, severe heart failure (class IV), persistent severe hypotension (systolic BP < 90mmHg), disorder of consciousness (DoC) |
Outcome
Primary Outcome Measures
1. Length of ICU stay [up to 60 days]
Secondary Outcome Measures
1. Length of hospital stay [up to 90 days]
