Functional Capacity in Survivors of COVID-19 Related ARDS
3 juillet 2021 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Anticipé)
15
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Ihsan Solaroglu, Prof
- Numéro de téléphone: + 90 212 338 10 39
- E-mail: isolaroglu@ku.edu.tr
Sauvegarde des contacts de l'étude
- Nom: Baris Ata, Prof
- Numéro de téléphone: + 90 212 338 10 39
- E-mail: bata@ku.edu.tr
Lieux d'étude
-
-
-
Istanbul, Turquie, 34010
- Koc University School of Medicine
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Acute respiratory distress syndrome survivors related to COVID-19
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Six-minute walk test
Délai: 1 day
|
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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Handgrip strength
Délai: 1 day
|
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
|
|
Medical Research Council-sumscore
Délai: 1 day
|
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
|
|
Short form - 36
Délai: 1 day
|
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
|
|
Chair stand test
Délai: 1 day
|
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
|
|
timed up and go test
Délai: 1 day
|
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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Anticipé)
1 juillet 2021
Achèvement primaire (Anticipé)
1 août 2021
Achèvement de l'étude (Anticipé)
1 septembre 2021
Dates d'inscription aux études
Première soumission
3 juillet 2021
Première soumission répondant aux critères de contrôle qualité
3 juillet 2021
Première publication (Réel)
7 juillet 2021
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
7 juillet 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 juillet 2021
Dernière vérification
1 juillet 2021
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2021.014.IRB1.008
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Covid19
-
Anavasi DiagnosticsPas encore de recrutement
-
Ain Shams UniversityRecrutement
-
Israel Institute for Biological Research (IIBR)Complété
-
Colgate PalmoliveComplété
-
Christian von BuchwaldComplété
-
Luye Pharma Group Ltd.Shandong Boan Biotechnology Co., LtdActif, ne recrute pas
-
University of ZurichLabor Speiz; Swiss Armed Forces; Universitätsspital ZürichInscription sur invitation
-
Alexandria UniversityComplété