Physical Rehabilitation in ICU in ARDS Patients With COVID-19

Sponsor

Koç University (Other)

Overall Status

Completed

CT.gov ID

NCT04435080

Collaborator

(none)

Enrollment

Location

2.9

Actual Duration (Months)

12.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Acute Respiratory Distress Syndrome Rehabilitation Intensive Care Unit Acquired Weakness Critical Illness Polyneuromyopathy

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.

Study Design

Study Type:

Observational

Actual Enrollment :

35 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Mar 15, 2020

Actual Primary Completion Date :

Jun 11, 2020

Actual Study Completion Date :

Jun 11, 2020

Arms and Interventions

Arm	Intervention/Treatment
Non-rehabilitation The patients hospitalised in ICU who were provided all the intensive care managements except for rehabilitation interventions (discharged from intensive care unit before April 14, 2020)
Rehabilitation The patients hospitalised in ICU who were provided rehabilitation interventions in addition to all the intensive care managements. (discharged from intensive care unit after April 14, 2020)

Outcome Measures

Primary Outcome Measures

Hand grip strength [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 Outcome Measures

Short form - 36 [1 month after discharge from hospital]
Short form - 36 measures health related quality of life. It is a self-reported survey that evaluates individual health status with eight parameters consisting of physical function, pain, role limitations attributed to physical problems, role limitations attributed to emotional problems, mental health, social functioning, energy/ vitality, general health perception. There is not a summary score, each section is scored between 0-100, 0 indicates the worst condition, 100 indicates the best. The measurement was performed 1 month after discharge.
Length of stay in intensive care unit [through study completion, an average of 3 months]
Number of days of stay in intensive care unit from admission to discharge
Length of stay in hospital [through study completion, an average of 3 months]
Number of days of stay in hospital from admission to hospital to discharge from hospital
Duration of invasive mechanical ventilation [through study completion, an average of 3 months]
Number of days of invasive mechanical ventilation during intensive care unit
Manual muscle strength [1 month after discharge from hospital]
Manual muscle strength was graded via a composite of Medical Research Council Scale score which has an excellent inter-rater reliability in survivors of critical illness. This scale range from 0 point (no muscle contraction) to 5 points (normal muscle strength). Through examination of 3 muscle groups in each limb (arm abduction, forearm flexion, wrist extension, hip flexion, knee extension and ankle dorsiflexion), clinical important muscle weakness has been defined as a composite score < 48 out of maximum 60 points. The measurement was performed 1 month after discharge.
Range of joint motion [1 month after discharge from hospital]
Range of joint motion was evaluated in upper and lower extremity joints by physical examination and the results were recorded as normal or restricted for each joint. The measurement was performed 1 month after discharge.