Rehabilitation for People With COVID-19 in ICU

NCT ID: NCT04381338

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-28
• Study Completion Date: 2020-12-31

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

Conditions

Corona Virus Disease 19 (COVID-19); COVID; Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS); Critical Illness

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Pulmonary and Motor Rehabilitation

Intervention Type: OTHER

Pulmonary and Motor Rehabilitation in ICU

COVID-19 in ICU without Rehabilitation

Standard of care without rehabilitation in ICU

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pulmonary and Motor Rehabilitation

Pulmonary and Motor Rehabilitation in ICU

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prof. S Masiero, University of Padova, Italy

UNKNOWN

Sponsor Role: collaborator

Dr. A. Venturin, General Hosipital, Padova, Italy

UNKNOWN

Sponsor Role: collaborator

Dr. I. Tiberio, General Hospital, Padova, Italy

UNKNOWN

Sponsor Role: collaborator

Dr. D. Zampieri, University of Padova, Italy

UNKNOWN

Sponsor Role: collaborator

Dr.ssa M Cattelan, University of Padova, Italy

UNKNOWN

Sponsor Role: collaborator

Prof. P. Zanatta, University Hosiptal, Verona, Italy

UNKNOWN

Sponsor Role: collaborator

Dr.ssa C. Carollo, General Hospital, Padova, Italy

UNKNOWN

Sponsor Role: collaborator

Prof. E. Polati, University Hospital, Verona, Italy

UNKNOWN

Sponsor Role: collaborator

Prof. K. Donadello, University Hospital, Verona, Italy

UNKNOWN

Sponsor Role: collaborator

University of Padova

OTHER

Sponsor Role: lead

Responsible Party

Alessandra Del Felice

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alessandra Del Felice, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Padova

Locations

Teaching Hospital, University of Padova

Padua, , Italy

Teaching Hospital, University of Verona

Verona, , Italy

Countries

Italy

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Other Identifiers

UPadova_1

Identifier Type: -

Identifier Source: org_study_id