Functional Capacity in Survivors of COVID-19 Related ARDS
3 luglio 2021 aggiornato da: Koç University
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.
Panoramica dello studio
Stato
Non ancora reclutamento
Descrizione dettagliata
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.
Tipo di studio
Osservativo
Iscrizione (Anticipato)
15
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Ihsan Solaroglu, Prof
- Numero di telefono: + 90 212 338 10 39
- Email: isolaroglu@ku.edu.tr
Backup dei contatti dello studio
- Nome: Baris Ata, Prof
- Numero di telefono: + 90 212 338 10 39
- Email: bata@ku.edu.tr
Luoghi di studio
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Istanbul, Tacchino, 34010
- Koc University School of Medicine
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
Acute respiratory distress syndrome survivors related to COVID-19
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Six-minute walk test
Lasso di tempo: 1 day
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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
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1 day
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Handgrip strength
Lasso di tempo: 1 day
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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.
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1 day
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Medical Research Council-sumscore
Lasso di tempo: 1 day
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It is valid and reliable tool in survivors of critical illness, it will be used in order to evaluate the overall muscle strength
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1 day
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Short form - 36
Lasso di tempo: 1 day
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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.
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1 day
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Chair stand test
Lasso di tempo: 1 day
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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.
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1 day
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timed up and go test
Lasso di tempo: 1 day
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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.
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1 day
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Anticipato)
1 luglio 2021
Completamento primario (Anticipato)
1 agosto 2021
Completamento dello studio (Anticipato)
1 settembre 2021
Date di iscrizione allo studio
Primo inviato
3 luglio 2021
Primo inviato che soddisfa i criteri di controllo qualità
3 luglio 2021
Primo Inserito (Effettivo)
7 luglio 2021
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
7 luglio 2021
Ultimo aggiornamento inviato che soddisfa i criteri QC
3 luglio 2021
Ultimo verificato
1 luglio 2021
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2021.014.IRB1.008
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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