Functional Capacity in Survivors of COVID-19 Related ARDS

Covid19 Clinical Trial

Official title:

Functional Capacity in Survivors of COVID-19 Related ARDS: A Cross-sectional Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04952844
• Other study ID #: 2021.014.IRB1.008
• Status: Not yet recruiting
• Start date: July 2021
• Est. completion date: September 2021

Study information

• Verified date: July 2021
• Source: Koç University
• Contact: Ihsan Solaroglu, Prof
• Phone: + 90 212 338 10 39
• Email: isolaroglu[@]ku.edu.tr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

COVID-19 could cause acute respiratory distress syndrome in a minority of patients. After recovery from acute critical illness and discharged from hospital, secondary disabilities related to Post Intensive Care Syndrome could take over the role. There is limited data and information about the functional capacity of these patients after hospital discharge.Follow-up these patients after discharge might help assessing the symptoms of Post Intensive Care Syndrome, functional capacity and need of physical therapy, therefore give care for the impairments. The aim of this retrospective cross-sectional study is to demonstrate 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. Appointment was given all of the ARDS survivors related to COVID-19 who treated in ICU after 4 weeks following discharge from hospital in order to assess the need of rehabilitation. 15 patients who attended the evaluation will be included the study.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: September 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Covid19
• Functional Capacity
• Post-intensive Care Syndrome
• Syndrome

Locations

Country	Name	City	State
Turkey	Koc University School of Medicine	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Koç University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

Chan KS, Zheng JP, Mok YW, Li YM, Liu YN, Chu CM, Ip MS. SARS: prognosis, outcome and sequelae. Respirology. 2003 Nov;8 Suppl:S36-40. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Handgrip strength	Handgrip strength will be measured using a handheld dynamometer according to the instructions of the American Society of Hand Therapists. Patients will be requested to seat placing their arms by their sides with the elbow flexed to 90°, the forearm mid-prone, and the wrist in neutral position. Using standard verbal encouragement, patients will be asked to grip the dynamometer with dominant hand with maximal effort. Three trials will be performed with a 30-second interval between trials and the highest value will be recorded in kg. The cut-off values of grip strength are 28.6 kg in men and 16.4 kg in women.	1 day
Secondary	Medical Research Council-sumscore	It is valid and reliable tool in survivors of critical illness, it will be used in order to evaluate the overall muscle strength	1 day
Secondary	Short form - 36	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.	1 day
Secondary	Chair stand test	It is used to evaluate strength and endurance of lower limbs. Patients will be asked to sit on a chair with a 46 cm seat height by crossing their hands over their chest and stand and sit five times consecutively as fast as possible. The test starts in the sitting position and terminate at the last sitting position and the time will be recorded.	1 day
Secondary	timed up and go test	The test will be used to assess physical function. It is an objective, reliable and simple test to evaluate both balance and functional movement. The patients will be asked to get up from a chair, walk 3 m, turn around, walk back and sit on the chair again. The time will be recorded in seconds.	1 day