Skip to main content
Clinical Trials/NCT04435080
NCT04435080
Completed
Not Applicable

Physical Rehabilitation in Intensive Care Unit in Acute Respiratory Distress Syndrome Patients With COVID-19

Koç University1 site in 1 country35 target enrollmentMarch 15, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19
Sponsor
Koç University
Enrollment
35
Locations
1
Primary Endpoint
Hand grip strength
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 15, 2020
End Date
June 11, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Koç University
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Hand grip strength

Time Frame: 1 month after discharge from hospital

Hand grip strength is an indicator of overall muscle strength that predicts mortality in older patients. Handgrip strength was measured using a handheld dynamometer according to the instructions of the American Society of Hand Therapists.Patients were seated placing their arms by their sides with the elbow flexed to 90°, the forearm mid-prone, and the wrist in neutral position. Patients were asked to grip the dynamometer with maximal effort using standard verbal encouragement. Three trials were performed in the dominant hand with a 30 sec rest between trials and the highest value was recorded in kg. The cut-off values of grip strength is 28.6 kg in men and 16.4 kg in women. The measurement was performed 1 month after discharge.

Secondary Outcomes

  • Length of stay in hospital(through study completion, an average of 3 months)
  • Length of stay in intensive care unit(through study completion, an average of 3 months)
  • Short form - 36(1 month after discharge from hospital)
  • Duration of invasive mechanical ventilation(through study completion, an average of 3 months)
  • Manual muscle strength(1 month after discharge from hospital)
  • Range of joint motion(1 month after discharge from hospital)

Study Sites (1)

Loading locations...

Similar Trials