Physical Rehabilitation in ICU in ARDS Patients With COVID-19

NCT04435080 | Completed

• 1 other identifier: 2020.169.IRB1.037
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Hand grip strength

  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.

  1 month after discharge from hospital

Secondary Outcomes (6)

• Short form - 36

  1 month after discharge from hospital

• Length of stay in intensive care unit

  through study completion, an average of 3 months

• Length of stay in hospital

  through study completion, an average of 3 months

• Duration of invasive mechanical ventilation

  through study completion, an average of 3 months

• Manual muscle strength

  1 month after discharge from hospital

Study Arms (2)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Koç University: lead

Study Sites (1)

Koc University School of Medicine

Istanbul, 34010, Turkey (Türkiye)

Location

Related Publications (10)

• Reid CL, Campbell IT, Little RA. Muscle wasting and energy balance in critical illness. Clin Nutr. 2004 Apr;23(2):273-80. doi: 10.1016/S0261-5614(03)00129-8.

  PMID: 15030968 RESULT

• Clavet H, Hebert PC, Fergusson D, Doucette S, Trudel G. Joint contracture following prolonged stay in the intensive care unit. CMAJ. 2008 Mar 11;178(6):691-7. doi: 10.1503/cmaj.071056.

  PMID: 18332384 RESULT

• Sosnowski K, Lin F, Mitchell ML, White H. Early rehabilitation in the intensive care unit: an integrative literature review. Aust Crit Care. 2015 Nov;28(4):216-25. doi: 10.1016/j.aucc.2015.05.002. Epub 2015 Jul 2.

  PMID: 26142542 RESULT

• Connolly B, O'Neill B, Salisbury L, Blackwood B; Enhanced Recovery After Critical Illness Programme Group. Physical rehabilitation interventions for adult patients during critical illness: an overview of systematic reviews. Thorax. 2016 Oct;71(10):881-90. doi: 10.1136/thoraxjnl-2015-208273. Epub 2016 May 24.

  PMID: 27220357 RESULT

• Walsh CJ, Batt J, Herridge MS, Dos Santos CC. Muscle wasting and early mobilization in acute respiratory distress syndrome. Clin Chest Med. 2014 Dec;35(4):811-26. doi: 10.1016/j.ccm.2014.08.016. Epub 2014 Sep 30.

  PMID: 25453427 RESULT

• Akar O, Gunay E, Sarinc Ulasli S, Ulasli AM, Kacar E, Sariaydin M, Solak O, Celik S, Unlu M. Efficacy of neuromuscular electrical stimulation in patients with COPD followed in intensive care unit. Clin Respir J. 2017 Nov;11(6):743-750. doi: 10.1111/crj.12411. Epub 2015 Dec 16.

  PMID: 26597394 RESULT

• Kleyweg RP, van der Meche FG, Schmitz PI. Interobserver agreement in the assessment of muscle strength and functional abilities in Guillain-Barre syndrome. Muscle Nerve. 1991 Nov;14(11):1103-9. doi: 10.1002/mus.880141111.

  PMID: 1745285 RESULT

• Turan Z, Ozyemisci Taskiran O, Erden Z, Kokturk N, Kaymak Karatas G. Does hand grip strength decrease in chronic obstructive pulmonary disease exacerbation? A cross-sectional study. Turk J Med Sci. 2019 Jun 18;49(3):802-808. doi: 10.3906/sag-1811-22.

  PMID: 31190519 RESULT

• Yoo JI, Choi H, Ha YC. Mean Hand Grip Strength and Cut-off Value for Sarcopenia in Korean Adults Using KNHANES VI. J Korean Med Sci. 2017 May;32(5):868-872. doi: 10.3346/jkms.2017.32.5.868.

  PMID: 28378563 RESULT

• Dodoo-Schittko F, Brandstetter S, Blecha S, Thomann-Hackner K, Brandl M, Knuttel H, Bein T, Apfelbacher C. Determinants of Quality of Life and Return to Work Following Acute Respiratory Distress Syndrome. Dtsch Arztebl Int. 2017 Feb 17;114(7):103-109. doi: 10.3238/arztebl.2017.0103.

  PMID: 28302253 RESULT

MeSH Terms

Conditions

COVID-19; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Ozden Ozyemisci Taskiran, Prof

  Koc University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 17, 2020
• Study Start: March 15, 2020
• Primary Completion: June 11, 2020
• Study Completion: June 11, 2020
• Last Updated: June 17, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)