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Physical Rehabilitation in ICU in ARDS Patients With COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04435080
Recruitment Status : Completed
First Posted : June 17, 2020
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
Koç University

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
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.

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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 : March 15, 2020
Actual Primary Completion Date : June 11, 2020
Actual Study Completion Date : June 11, 2020


Group/Cohort
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)



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Short form - 36 [ Time Frame: 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.

  2. Length of stay in intensive care unit [ Time Frame: through study completion, an average of 3 months ]
    Number of days of stay in intensive care unit from admission to discharge

  3. Length of stay in hospital [ Time Frame: through study completion, an average of 3 months ]
    Number of days of stay in hospital from admission to hospital to discharge from hospital

  4. Duration of invasive mechanical ventilation [ Time Frame: through study completion, an average of 3 months ]
    Number of days of invasive mechanical ventilation during intensive care unit

  5. Manual muscle strength [ Time Frame: 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.

  6. Range of joint motion [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04435080


Locations
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Turkey
Koc University School of Medicine
Istanbul, Turkey, 34010
Sponsors and Collaborators
Koç University
Investigators
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Principal Investigator: Ozden Ozyemisci Taskiran, Prof Koc University School of Medicine
Publications of Results:

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Responsible Party: Koç University
ClinicalTrials.gov Identifier: NCT04435080    
Other Study ID Numbers: 2020.169.IRB1.037
First Posted: June 17, 2020    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: It was not planned to share individual participant data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Koç University:
COVID-19
Acute Respiratory Distress Syndrome
Early rehabilitation
Intensive care unit acquired weakness
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Critical Illness
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Disease Attributes