Clinical trial NCT04435080: Physical Rehabilitation in ICU in ARDS Patients With COVID-19
Official title: Physical Rehabilitation in Intensive Care Unit in Acute Respiratory Distress Syndrome Patients With COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Acute Respiratory Distress Syndrome
Rehabilitation
Intensive Care Unit Acquired Weakness
Critical Illness Polyneuromyopathy
Keywords: COVID-19
Acute Respiratory Distress Syndrome
Early rehabilitation
Intensive care unit acquired weakness
Lead sponsor: Koç University
Sponsor class: OTHER
First posted: 2020-06-17
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients that hospitalized due to acute respiratory distress syndrome secondary to COVID-19 were enrolled this study. The rehabilitation program was started at April 14, 2020 in intensive care unit. Until April 14, 2020 all patients were provided all the intensive care managements, except for rehabilitation. Therefore, patients discharged before this time constituted the 'non-rehabilitation' group of the present study. All patients discharged after April 14 were provided rehabilitation in addition to usual care and constituted the study 'rehabilitation' group

Brief summary: The primary aim of this study is to evaluate the effect of physical rehabilitation performed in intensive care unit on the range of joint motions and muscle strength of survivors following discharge from intensive care unit in patients with COVID-19. Secondary outcome is to assess the duration of mechanical ventilation, length of stay in intensive care unit and in hospital, and mortality rates during intensive care unit stay and health related quality of life following discharge in survivors.

Until April 14 patients were provided all the intensive care managements except for rehabilitation and patients discharged before this time constituted the 'non-rehabilitation' group (n=17). Patients discharged after April 14 were provided rehabilitation in addition to usual intensive care unit care and constituted the study 'rehabilitation' group (n=18).

Passive range of motion exercises to each joint and neuromuscular electrical stimulation to bilateral quadriceps and tibialis anterior muscles were applied 6 days/week in the 'rehabilitation' group during intensive care unit stay.

Detailed description: Patients with acute respiratory distress syndrome could develop muscle weakness associated with impairment of physical function defined as intensive care unit acquired weakness. Early rehabilitation is recommended to prevent complications including muscle weakness and joint contractures, enhance weaning from mechanical ventilation, improve outcome, quality of life.

COVID-19 is an acute infection with a high risk of enormous cytokine storm exacerbating the clinical condition in acute respiratory distress syndrome and is thought to further increase the risk of muscle weakness.

Study participants were recruited among patients hospitalized in the intensive care unit at Koc University Hospital. Standard care for these patients consisted of respiratory support, intravenous fluid therapy, medical treatment including anticoagulation and sedation, nutrition, change of position every 4 hours, and if needed, hemodynamic support. The non-rehabilitation group patients discharged before April 14, 2020, were provided with this standard care. The rehabilitation group patients that discharged after April 14, 2020, were provided rehabilitation in addition to usual standard care. The rehabilitation program consisted of a passive range of motion exercises for each joint of the extremities for 15 minutes/day, 6 days/week, and neuromuscular electrical stimulation to bilateral quadriceps and tibialis anterior muscles for 52 minutes/day, 6 days/week. The physiatrists evaluated the patients. Exercises and electrical stimulation were applied daily by physiotherapists. The physiatrist and anesthesiologist discussed the clinical status of the patients daily and the physiatrist modified the rehabilitation program, if needed. Patients were enrolled in the rehabilitation program if there is hemodynamical stability.

Information regarding demographic and clinical features, medications used, duration of mechanical ventilation, length of stay in the intensive care unit and hospital, and mortality were obtained from the digital patient records in both groups.

Following discharge, patients were evaluated for range of joint motion, manual muscle strength test, hand grip strength and Short form-36.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of acute respiratory distress syndrome secondary to COVID-19
* Hospitalised in intensive care unit
* Age older than 18 years

Exclusion Criteria:

* Acute respiratory distress syndrome due to other pathogens or causes
* Younger than 18 years

Primary outcomes:
measure: Hand grip strength
timeFrame: 1 month after discharge from hospital
Secondary outcomes:
measure: Short form - 36
timeFrame: 1 month after discharge from hospital
measure: Length of stay in intensive care unit
timeFrame: through study completion, an average of 3 months
measure: Length of stay in hospital
timeFrame: through study completion, an average of 3 months
measure: Duration of invasive mechanical ventilation
timeFrame: through study completion, an average of 3 months
measure: Manual muscle strength
timeFrame: 1 month after discharge from hospital
measure: Range of joint motion
timeFrame: 1 month after discharge from hospital
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Koc University School of Medicine
Study officials:
affiliation: Koc University School of Medicine
name: Ozden Ozyemisci Taskiran, Prof
role: PRINCIPAL_INVESTIGATOR
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