Clinical trial NCT04381338: Rehabilitation for People With COVID-19 in ICU
Official title: Pulmonary and Motor Rehabilitation for People With COVID-19 in Intensive Care Units to Reduce Length of Stay in Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Corona Virus Disease 19 (COVID-19)
COVID
Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
Critical Illness
Keywords: Recovery
Outcome
retraining
corona virus disease 19
Lead sponsor: University of Padova
Sponsor class: OTHER
Collaborators: name: Prof. S Masiero, University of Padova, Italy
name: Dr. A. Venturin, General Hosipital, Padova, Italy
name: Dr. I. Tiberio, General Hospital, Padova, Italy
name: Dr. D. Zampieri, University of Padova, Italy
name: Dr.ssa M Cattelan, University of Padova, Italy
name: Prof. P. Zanatta, University Hosiptal, Verona, Italy
name: Dr.ssa C. Carollo, General Hospital, Padova, Italy
name: Prof. E. Polati, University Hospital, Verona, Italy
name: Prof. K. Donadello, University Hospital, Verona, Italy
First posted: 2020-05-08
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clustered, due to catchment area of Hospital with no chance of contamination because of lock down in the area.
Primary purpose: TREATMENT

Brief summary: COVID-19 DISEASE Coronavirus disease 2019 (COVID-19) is a respiratory tract infection caused by a newly emergent coronavirus, severe acute respiratory syndrome from COVID-19, that was first recognized in Wuhan, China, in December 2019. While most people with COVID-19 develop mild or uncomplicated illness, approximately 14% develop severe disease requiring hospitalization and oxygen support and 5% require admission to an intensive care unit. In severe cases, COVID-19 can be complicated by acute respiratory disease syndrome (ARDS) requiring prolonged mechanical ventilation, sepsis and septic shock, multiorgan failure, including acute kidney, liver and cardiac injury.

ARDS REHABILITATION Critically ill people who undergo prolonged mechanical ventilation often develop weakness, with severe symmetrical weakness of and deconditioning of the proximal musculature and of the respiratory muscles (critical illness neuropathy/myopathy).These individuals also develop significant functional impairment and reduced health-related quality of life (HRQL) up to 2 and 5 years after discharge.

ARDS survivors may complain of depression, anxiety, memory disturbances, and difficulty with concentration often unchanged at 2 and 5 years. Less than half of all ARDS survivors return to work within the first year following discharge, two-thirds at two years, and more than 70% at five years.

Early physiotherapy (PT) of people with ARDS has recently been suggested as a complementary therapeutic tool to improve early and late outcomes. The aims of PT programs should be to reduce complications of immobilization and ventilator-dependency, to improve residual function, to prevent new hospitalisations, and to improve health status and HRQL. Physiotherapy in critical patients is claimed also to prevent and contribute to treat respiratory complications such as secretion retention, atelectasis, and pneumonia. Early mobilization and maintenance of muscle strength may reduce the risk of difficult weaning, limited mobility, and ventilator dependency.

Lastly, pulmonary rehabilitation in ICU in mechanically ventilated subjects may reduce length of stay in ICU up to 4.5 day, shorten mechanical ventilation of 2.3 days and weaning by 1.7 days.

The aim of this study is to investigate how early pulmonary and motor rehabilitation impacts on length of hospital admission (ICU and acute ward) and early and late outcomes inpatients that develop ARDS due to COVID-19.

Detailed 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; \<Grade 3 MRC strength, active assist to active Repetitions for strength training: Start 5 repetitions each limb, Progress to 3 sets of 10 repetitions as able Functional retraining: Sit-to-stand (using tilt table or standing walker if unable), rolling, supine to sitting, trunk control/balance

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

Eligibility 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 \&lt; 90mmHg), disorder of consciousness (DoC)

Primary outcomes:
measure: Length of ICU stay
timeFrame: up to 60 days
Secondary outcomes:
measure: Length of hospital stay
timeFrame: up to 90 days
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Teaching Hospital, University of Padova
city: Verona
country: Italy
facility: Teaching Hospital, University of Verona
Study officials:
affiliation: University of Padova
name: Alessandra Del Felice, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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