Functional Capacity in Survivors of COVID-19 Related ARDS

NCT04952844 | Unknown

• 1 other identifier: 2021.014.IRB1.008
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Acute respiratory distress syndrome survivors frequently develop impaired physical function, muscle weakness and quality of life. The aim of this retrospective study is to determine the functional capacity, global muscle weakness and quality of life of COVID-19 survivors after 4 weeks following hospital discharge and the relationship between different tools. COVID-19 related acute respiratory distress syndrome survivors were assessed 4 weeks following discharge from the hospital, 15 patients who attended the evaluation will be included the study. All subjects underwent standardized physical clinical evaluation, Medical Research Council-sumscore, hand-grip strength, 6-minute walk test, chair-stand test, timed up and go test and Short form-36, 4 weeks after hospital discharge.

Conditions

Covid19; Functional Capacity; Post-intensive Care Syndrome

Keywords

COVID-19; Acute Respiratory Distress Syndrome; 6-minute walk test; handgrip strength; MRC sumscore

Outcome Measures

Primary Outcomes (1)

• Six-minute walk test

  Six-minute walk test is a field test evaluating submaximal aerobic capacity. The technical standards are defined by European Respiratory Society and American Thoracic Society. The individuals were asked to walk as far as possible in a 30-meter corridor in 6 minutes and the distance, oxygen saturation, heart rate, systolic blood pressure and dyspnea scale (Borg 0-20) were recorded before and immediately after the test, and recovery period (1. minute of recovery). It is a valid and responsive measurement of functional capacity and also predicts quality of life in Acute respiratory distress syndrome survivors

  1 day

Secondary Outcomes (5)

• Handgrip strength

  1 day

• Medical Research Council-sumscore

  1 day

• Short form - 36

  1 day

• Chair stand test

  1 day

• timed up and go test

  1 day

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

Acute respiratory distress syndrome survivors related to COVID-19

You may qualify if:

• to be older that 18 years
• Acute respiratory distress syndrome survivors related to COVID-19 who treated in Intensive care unit and attend appointment after 4 weeks following discharge from hospital

You may not qualify if:

• History of diseases that could affect functional capacity, muscle strength and quality of life, such as cancer, spinal cord disease, neuromuscular diseases
• do not want to attend the study

Sponsors & Collaborators

• Koç University: lead

Study Sites (1)

Koc University School of Medicine

Istanbul, 34010, Turkey (Türkiye)

Location

Related Publications (7)

• Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.

  PMID: 32091533 BACKGROUND

• Held N, Moss M. Optimizing Post-Intensive Care Unit Rehabilitation. Turk Thorac J. 2019 Apr 1;20(2):147-152. doi: 10.5152/TurkThoracJ.2018.18172. Print 2019 Apr.

  PMID: 30958989 BACKGROUND

• Ngai JC, Ko FW, Ng SS, To KW, Tong M, Hui DS. The long-term impact of severe acute respiratory syndrome on pulmonary function, exercise capacity and health status. Respirology. 2010 Apr;15(3):543-50. doi: 10.1111/j.1440-1843.2010.01720.x. Epub 2010 Mar 19.

  PMID: 20337995 BACKGROUND

• Turan Z, Topaloglu M, Ozyemisci Taskiran O. Medical Research Council-sumscore: a tool for evaluating muscle weakness in patients with post-intensive care syndrome. Crit Care. 2020 Sep 18;24(1):562. doi: 10.1186/s13054-020-03282-x. No abstract available.

  PMID: 32948221 BACKGROUND

• Wilcox ME, Herridge MS. Lung function and quality of life in survivors of the acute respiratory distress syndrome (ARDS). Presse Med. 2011 Dec;40(12 Pt 2):e595-603. doi: 10.1016/j.lpm.2011.04.024. Epub 2011 Nov 9.

  PMID: 22078086 BACKGROUND

• Chan KS, Zheng JP, Mok YW, Li YM, Liu YN, Chu CM, Ip MS. SARS: prognosis, outcome and sequelae. Respirology. 2003 Nov;8 Suppl(Suppl 1):S36-40. doi: 10.1046/j.1440-1843.2003.00522.x.

  PMID: 15018132 BACKGROUND

• Hui DS, Wong KT, Ko FW, Tam LS, Chan DP, Woo J, Sung JJ. The 1-year impact of severe acute respiratory syndrome on pulmonary function, exercise capacity, and quality of life in a cohort of survivors. Chest. 2005 Oct;128(4):2247-61. doi: 10.1378/chest.128.4.2247.

  PMID: 16236881 BACKGROUND

MeSH Terms

Conditions

COVID-19; postintensive care syndrome; 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

Central Study Contacts

Ihsan Solaroglu, Prof

CONTACT

+ 90 212 338 10 39; isolaroglu@ku.edu.tr

Baris Ata, Prof

CONTACT

+ 90 212 338 10 39; bata@ku.edu.tr

Study Design

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

Study Record Dates

• First Submitted: July 3, 2021
• First Posted: July 7, 2021
• Study Start: July 1, 2021
• Primary Completion: August 1, 2021
• Study Completion: September 1, 2021
• Last Updated: July 7, 2021

Record last verified: 2021-07

Locations

TU (1)