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Covid19NCT04952844

Functional Capacity in Survivors of COVID-19 Related ARDS

An observational study of Covid19 and Functional Capacity, run by Koç University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
How many people
15 participants
Where
1 siteTurkey (Türkiye)
Study dates
Jul 2021to Sep 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Acute respiratory distress syndrome survivors related to COVID-19

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

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

Turkey (Türkiye)1 site

  • Koc University School of Medicine

    Istanbul, 34010

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the detailed 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.

Keywords
COVID-19, Acute Respiratory Distress Syndrome, 6-minute walk test, handgrip strength, MRC sumscore
Medical subject headings
COVID-19, postintensive care syndrome, Respiratory Distress Syndrome

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1 day

Secondary outcomes (5)

  1. 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.

    Measured: 1 day

  2. 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

    Measured: 1 day

  3. 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.

    Measured: 1 day

  4. 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.

    Measured: 1 day

  5. 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.

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2021
  2. Study startJul 2021 (estimated)
  3. Primary completionAug 2021 (estimated)
  4. Study completionSep 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Retrospective
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04952844
Sponsor's protocol ID
2021.014.IRB1.008
Status last verified
Jul 2021
First submitted
3 Jul 2021
Last updated
7 Jul 2021
Results posted
No

Publications

  • 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.

    PubMed 32091533

  • 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.

    PubMed 30958989

  • 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.

    PubMed 20337995

  • 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.

    PubMed 32948221

  • 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.

    PubMed 22078086

  • 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.

    PubMed 15018132

  • 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.

    PubMed 16236881

Questions about this trial

What is this clinical trial studying?

An observational study of Covid19 and Functional Capacity, run by Koç University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ihsan Solaroglu, Prof (+ 90 212 338 10 39, isolaroglu@ku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Six-minute walk test (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04952844, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021.

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