Is Tele-rehabilitation Superior to Home Exercise Program in the Pulmonary Rehabilitation of the Patients With COVID-19 With Post-intensive Care Syndrome? A Randomized Controlled Trial
Remote controlled exercise
+ Home exercise
COVID-19+9
+ Infections à Coronaviridae
+ Infections
Étude thérapeutique
Résumé
Date de début de l'étude : 1 septembre 2020
Date à laquelle le premier participant a commencé l'étude.COVID-19 could cause respiratory distress in a minority of cases and requires intensive care and mechanical ventilation. When patients recover and are discharged from hospital, physical, cognitive and emotional complications known as post-intensive care syndrome is seen in the majority of patients and requires rehabilitation. Pulmonary rehabilitation is a comprehensive intervention consists of assessment of patient, exercise training and education in order to improve physical and psychological condition of people with chronic respiratory disease. The patients with COVID-19 with post-intensive care syndrome will be randomized two groups: Tele-rehabilitation group and home exercise group. There will not be a non-exercising control group due to the ethical issues. The exercise program of both groups will be prescribed by a physiatrist based on the physical examination and the functional capacity of the patients. Tele-rehabilitation group will perform the exercise program 3 days/week for 10 weeks. One session will include aerobic, flexibility and strengthening exercises for lower and upper extremity and breathing exercise. The trainings will start with low-intensity exercises and intensity and duration of the exercises will progress according to the condition of the patient. Intensity of the exercises will be monitored by Borg scale based on dyspnea and exertion symptoms during the sessions. Home exercise group will perform the exercises at their home on their own, 3 days/week for 10 weeks. The patients will be trained about the individualised exercise program as the first session provided at the hospital. The physiotherapist will call the patients weekly, modifications in the exercise program will be made according to the patient's reports. Outcomes will be measured at baseline, within 1 week of completion the program, 6th months and 12th months following the rehabilitation.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.122 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
Comparateur actifGroupe II
Comparateur actifObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Koc University School of Medicine
Istanbul, Turkey (Türkiye)Ouvrir Koc University School of Medicine dans Google Maps