Ignite Creation Date:
2025-12-26 @ 12:15 PM
Ignite Modification Date:
2026-01-13 @ 12:25 PM
Study NCT ID:
NCT04678700
Status:
UNKNOWN
Last Update Posted:
2021-02-03
First Post:
2020-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementation of a Respiratory Physiotherapy Program in Post COVID-19 Patients Through Tele-assistance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Experimental study composed of an intervention group and a control group The control group will receive the intervention after finishing the intervention with the experimental group.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2021-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-01', 'studyFirstSubmitDate': '2020-12-12', 'studyFirstSubmitQcDate': '2020-12-19', 'lastUpdatePostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Euroqol-5d european quality of life-5 dimensions', 'timeFrame': '1 week', 'description': 'The EQ-5D is a generic Quality of Life measurement instrument. The individual himself evaluates his state of health, first in levels of severity by dimensions. The descriptive system contains five health dimensions (mobility, self-care, activities of daily living, pain/discomfort and anxiety/depression) and each one has three levels of severity (no problems, some moderate problems or problems and serious problems). In this part of the questionnaire, the individual must mark the level of severity corresponding to his or her state of health in each one of the dimensions, referring to the same day that he or she completes the questionnaire. In each dimension of the EQ-5D, the levels of severity are coded with a 1 if the answer option is "no (I have) problems"; with a 2 if the answer option is "some or moderate problems"; and with a 3 if the answer option is "many problems".'}, {'measure': 'Euroqol-5d european quality of life-5 dimensions', 'timeFrame': '4 week', 'description': 'The EQ-5D is a generic Quality of Life measurement instrument. The individual himself evaluates his state of health, first in levels of severity by dimensions. The descriptive system contains five health dimensions (mobility, self-care, activities of daily living, pain/discomfort and anxiety/depression) and each one has three levels of severity (no problems, some moderate problems or problems and serious problems). In this part of the questionnaire, the individual must mark the level of severity corresponding to his or her state of health in each one of the dimensions, referring to the same day that he or she completes the questionnaire. In each dimension of the EQ-5D, the levels of severity are coded with a 1 if the answer option is "no (I have) problems"; with a 2 if the answer option is "some or moderate problems"; and with a 3 if the answer option is "many problems".'}, {'measure': 'Dysnea scale Borg', 'timeFrame': '5 minutes before each session', 'description': 'The modified Borg scale is a visual analog scale standardized in Spanish that allows to evaluate the subjective perception of the breathing difficulty or the physical effort exercised.\n\nThis variable is taken in sedation'}, {'measure': 'Dysnea scale Borg', 'timeFrame': '5 minutes after each session', 'description': 'The modified Borg scale is a visual analog scale standardized in Spanish that allows to evaluate the subjective perception of the breathing difficulty or the physical effort exercised.\n\nThis variable is taken in sedation'}, {'measure': 'Respiratory rate', 'timeFrame': '5 minutes before each session', 'description': 'breathing rate in one minute. The patient sitting upright takes the number of breaths per minute.'}, {'measure': 'Respiratory rate', 'timeFrame': '5 minutes after each session', 'description': 'breathing rate in one minute. The patient sitting upright takes the number of breaths per minute.'}, {'measure': 'Effort dysnea Scale', 'timeFrame': '1 week', 'description': 'Effort dyspnea scale, Malher Scale A multidimensional scale that measures 3 magnitudes of dyspnea at a given time: the difficulty of the task, the intensity of the effort and the functional impairment.'}, {'measure': 'Effort dysnea Scale', 'timeFrame': '4 week', 'description': 'Effort dyspnea scale, Malher Scale A multidimensional scale that measures 3 magnitudes of dyspnea at a given time: the difficulty of the task, the intensity of the effort and the functional impairment.'}, {'measure': 'Anxiety', 'timeFrame': '1 week', 'description': 'STAI, questionary of anxiety, we will take before the first session and at the end of the last session'}, {'measure': 'Anxiety', 'timeFrame': '4 week', 'description': 'STAI, questionary of anxiety, we will take before the first session and at the end of the last session'}, {'measure': 'Level oxigen %', 'timeFrame': '1 week', 'description': 'pulxe-oximetry, the patient is sitting at rest'}, {'measure': 'Level oxigen %', 'timeFrame': '4 week', 'description': 'pulxe-oximetry, the patient is sitting at rest'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chest physiotherapy', 'covid19', 'pulmonary rehabilitation covid19', 'physical therapy', 'coronavirus'], 'conditions': ['Covid19- Coronavirus- Sars-cov-2']}, 'descriptionModule': {'briefSummary': 'The objective of this research project is to scientifically evidence a pulmonary rehabilitation program that was initiated altruistically during the confinement of those patients who had suffered from COVID-19, through an online platform.\n\nPatients are connected telematically 3 times a week from April 6, 2020 to perform the physical therapy program. Due to the clinical improvements that have been referred by patients, they began to take objective data.\n\nOur goal is to know if a telematic respiratory therapy program in post-covid 19 patient, improves the level of anxiety, dyspnea on effort, improves quality of life and oxygenation.', 'detailedDescription': 'Patients affected by COVID- 19 have long periods of convalescence at home. This fact, together with the measures of social isolation, has contributed to act from a new therapeutic paradigm with the implementation of telematic rehabilitation programs.\n\nOn April 6, 2020 the online platform was born under the name "Respiratory Physiotherapy; telematic assistance in patients with COVID-19 sequelae".\n\nWe want to quantify the Chest Physiotherapy online program.\n\nHypothesis; An online respiratory physiotherapy program offers improvements in quality of life, dyspnea and anxiety to patients who have suffered COVID-19.\n\nObjectives; General objective; To improve the pulmonary function of patients who have suffered from COVID-19 infection through an online respiratory physiotherapy program.\n\nSecondary objectives;\n\n* To improve the sensation of dyspnea; quantified by the Malher and Borg scale\n* To Normalize Breathing Rate\n* To Improve oxigenation; pulse-oximetry\n* To Improve the quality of life; quantified Euroqol- 5D\n* To Improve the feeling of anxiety; quantified by the STAI questionnaire\n\nMETHODOLOGY/STUDY DESIGN; This is a program that was born under a very special need and circumstance, as is the coronavirus pandemic. The aim was to use respiratory tele-rehabilitation through an online platform with patients affected by coronavirus.\n\nThe study is voluntary, the patient can stop the program at any time he or she considers appropriate. All of this is informed in the consent form that you give us, duly signed.\n\nI'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients in the recovery phase, hospitalised or at home.\n* Patients diagnosed with positive PCR for COVID-19\n* Patient with sensation of dyspnea\n* Patient able to sit still\n\nExclusion Criteria:\n\n* Patients admitted to intensive care and/or hemodynamically unstable\n* Patients connected to mechanical ventilation\n* Patients who do not have integrated cognitive abilities\n* Patients who are receiving other respiratory rehabilitation programs\n* Patients without adecuate technologies ( WIFI, computer, email, zoom)'}, 'identificationModule': {'nctId': 'NCT04678700', 'briefTitle': 'Implementation of a Respiratory Physiotherapy Program in Post COVID-19 Patients Through Tele-assistance', 'organization': {'class': 'OTHER', 'fullName': 'European University of Madrid'}, 'officialTitle': 'Implementation of a Respiratory Physiotherapy Program in Post COVID-19 Patients Through Tele-assistance', 'orgStudyIdInfo': {'id': '20/139'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental groupe', 'description': "Intervention; 10 sessions telematics. Before starting and at the end of the respiratory physiotherapy program, the patient complete an online form which includes a quality of life questionnaire, an effort dyspnea questionnaire and an anxiety questionnaire.\n\nThe intervention of the following study follow the recommendations of chest physiotherapy in the management of the patient post covid-19 (1)(17).\n\nPre-session; respiratory frequency, dyspnea, oxigenation level are taken. Breathing techniques;\n\n* Abdominal-diaphragmatic breathing(1)(16). (10 times).\n* Costal expansion exercises with flexion and abduction of the upper limbs. (10 times)(1).\n* Self-passive stretching of the ribcage and neck muscles, accessory to inspiration(25)(26).\n* Jacobson's progressive relaxation(27). Post-session, respiratory frequency and the Borg's dyspnea index/ oxigenation level.", 'interventionNames': ['Other: Chest physiotherapy post-covid19']}, {'type': 'OTHER', 'label': 'control groupe', 'description': 'The control group will complete the same questionnaires before and after the intervention, which will give us an idea of whether our intervention has had any improvement. In order for all patients to be able to receive the therapy if they want to. The control group will be on the waiting list to perform the sessions.', 'interventionNames': ['Other: Chest physiotherapy post-covid19']}], 'interventions': [{'name': 'Chest physiotherapy post-covid19', 'type': 'OTHER', 'description': "The sessions are divided into the following modules;\n\n* Directed abdominal-diaphragmatic ventilation (10 times).\n* Costal expansion exercises with the help of flexion and abduction of the upper limbs. (10 times)(1).\n* Self-passive stretching of the ribcage and neck muscles, accessory to inspiration. The purpose of the stretching will be to increase the flexibility of the muscles to improve the vital capacity as has already been evidenced in other respiratory diseases such as chronic obstructive pulmonary disease (COPD) and cystic fibrosis (25)(26).\n\nRelaxation time;Jacobson's progressive relaxation; we scan the body's condition.\n\nPost-session evaluation by taking the respiratory frequency/ min and the Borg's dyspnea index, and level oxigen after the exercises.", 'armGroupLabels': ['Experimental groupe', 'control groupe']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28670', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Marta de la plaza, IP', 'role': 'CONTACT', 'email': 'marta_delaplaza@hotmail.com', 'phone': '659432984'}], 'facility': 'Marta de la plaza', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Marta de la plaza, IP', 'role': 'CONTACT', 'email': 'marta_delaplaza@hotmail.com', 'phone': '0034659432984'}, {'name': 'Marta de la plaza, IP', 'role': 'CONTACT', 'email': 'marta_delaplaza@hotmail.com'}], 'overallOfficials': [{'name': 'Marta de la plaza', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'European University of Madrid'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European University of Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physiotherapy teacher, PH student', 'investigatorFullName': 'Marta de la Plaza', 'investigatorAffiliation': 'European University of Madrid'}}}}