Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2025-12-26 @ 3:52 AM
Study NCT ID:
NCT04649918
Status:
COMPLETED
Last Update Posted:
2021-12-23
First Post:
2020-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Short and Medium-term Effects of Pulmonary Rehabilitation in Mild to Critical Post-acute COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D045169', 'term': 'Severe Acute Respiratory Syndrome'}], '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': 'D018352', 'term': 'Coronavirus Infections'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-01-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-22', 'studyFirstSubmitDate': '2020-11-25', 'studyFirstSubmitQcDate': '2020-12-01', 'lastUpdatePostDateStruct': {'date': '2021-12-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in 6-minute walk distance', 'timeFrame': 'Day 1 and day 21 of pulmonary rehabilitation', 'description': 'measure in meter'}], 'secondaryOutcomes': [{'measure': 'change in endurance shuttle walk distance', 'timeFrame': 'Day 1 and day 21 of pulmonary rehabilitation', 'description': 'measure provided in seconds'}, {'measure': 'Change in Diffusion capacity of the lungs for Carbon monoxide', 'timeFrame': 'Day 1 and day 21 of pulmonary rehabilitation', 'description': 'measure provided in % predicted'}, {'measure': 'Change in Forced Vital Capacity', 'timeFrame': 'Day 1 and day 21 of pulmonary rehabilitation', 'description': 'measure provided in % predicted'}, {'measure': 'Change in total lung capacity', 'timeFrame': 'Day 1 and day 21 of pulmonary rehabilitation', 'description': 'measure provided in % predicted'}, {'measure': 'change in Montreal cognitive assessment test', 'timeFrame': 'Day 1 and day 21 of pulmonary rehabilitation', 'description': 'score ranges from 0 to 30 with lower score indicating higher cognitive impairment'}, {'measure': 'change in short-form 36 question health survey', 'timeFrame': 'Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation', 'description': 'score ranges from 0 to 100 with higher scores indicating better Quality of life'}, {'measure': 'change in Patient-Reported Outcomes Measurement Information System - 29 (PROMIS-29)', 'timeFrame': 'Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation', 'description': 'A questionnaire designed to measure self-reported physical, mental and social health and wellbeing. Higher scores represent worse symptomatology in relation to the mean value of 50 points with a standard deviation of 10 points.'}, {'measure': 'Change in the scale of general anxiety disorder - 7 questionnaire (GAD-7)', 'timeFrame': 'Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation', 'description': 'score ranges from 0 to 21 with higher scores indicating more severe anxiety'}, {'measure': 'Change in the scale of the patient health questionnaire - Depression (PHQ-D)', 'timeFrame': 'Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation', 'description': 'score ranges from 0 to 27 with higher scores indicating more severe depression'}, {'measure': 'Change in prevalence of COVID-19 related dyspnea', 'timeFrame': 'Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation', 'description': 'patients will be asked if they still perceive COVID-19 related dyspnea: answer possibilities yes or no'}, {'measure': 'Change in prevalence of COVID-19 related cough', 'timeFrame': 'Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation', 'description': 'patients will be asked if they still perceive COVID-19 related cough: answer possibilities yes or no'}, {'measure': 'Change in prevalence of COVID-19 related cognitive impairment', 'timeFrame': 'Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation', 'description': 'patients will be asked if they still perceive COVID-19 related cognitive impairment: answer possibilities yes or no'}, {'measure': 'Change in prevalence of COVID-19 related loss of appetite', 'timeFrame': 'Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation', 'description': 'patients will be asked if they still perceive COVID-19 related loss of appetite: answer possibilities yes or no'}, {'measure': 'Change in general perceived well-being', 'timeFrame': 'Day 1 and day 21 of pulmonary rehabilitation and day 90 following pulmonary rehabilitation', 'description': 'scale from 1 (worst) to 10 (best)'}, {'measure': 'change in D-Dimer level', 'timeFrame': 'Day 1 and day 21 of pulmonary rehabilitation', 'description': 'in mg/l'}, {'measure': 'change in c-reactive protein level', 'timeFrame': 'Day 1 and day 21 of pulmonary rehabilitation', 'description': 'in mg/l'}, {'measure': 'change in leukocytes level', 'timeFrame': 'Day 1 and day 21 of pulmonary rehabilitation', 'description': 'in g/l'}, {'measure': 'change in hemoglobin level', 'timeFrame': 'Day 1 and day 21 of pulmonary rehabilitation', 'description': 'in g/dl'}, {'measure': 'change in troponin level', 'timeFrame': 'Day 1 and day 21 of pulmonary rehabilitation', 'description': 'in pg/ml'}, {'measure': 'change in pro-brain natriuretic peptide level', 'timeFrame': 'Day 1 and day 21 of pulmonary rehabilitation', 'description': 'in pg/ml'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19', 'SARS-CoV Infection', 'Pulmonary Rehabilitation', 'Quality of Life']}, 'descriptionModule': {'briefSummary': 'As a direct consequence of the COVID-19 pandemic, it is assumed that the number of patients with COVID-19-related disabilities will increase significantly. Patients with mild, severe, and critical forms of the disease show long-term sequelae in different systems (respiratory, muscular, psychological, cognitive etc.).\n\nPersistent dyspnea is a frequently described symptom after the acute phase of the disease. Coupled with reduced oxygen saturation, an increased risk of developing lung fibrosis has been observed. Specialized rehabilitation medicine (e.g. pulmonary rehabilitation) might counteract these long-term consequences and therefore seems to be a promising approach to treat long-term COVID-19 consequences.\n\nFurther, there is scarce evidence about COVID-19 specific rehabilitation contents. It was suggested to use treatment regimes in analogy to patients with idiopathic pulmonary fibrosis.\n\nThere is evidence that pulmonary rehabilitation improves physical performance, quality of life and reduces anxiety and depression symptoms in patients with idiopathic pulmonary fibrosis and other chronic respiratory diseases.\n\nSince impairments related to idiopathic pulmonary fibrosis also play an important role in COVID-19, the aim of this study is to evaluate the short and medium-term effects of a standardized 3-week pulmonary rehabilitation program. The results will be analyzed within the two cohorts (mild/moderate and severe/critical COVID 19) as well as between the two cohorts for the primary outcome. Furthermore, the effects of pulmonary rehabilitation will be compared with a retrospective cohort of idiopathic pulmonary fibrosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients referred for an inpatient pulmonary rehabilitation program at the reference center will be recruited', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Post-acute phase COVID-19 patients with mild, moderate, severe or critical course\n* written informed consent\n\nExclusion Criteria:\n\n* patients who are unable to walk'}, 'identificationModule': {'nctId': 'NCT04649918', 'acronym': 'STEPCO', 'briefTitle': 'Short and Medium-term Effects of Pulmonary Rehabilitation in Mild to Critical Post-acute COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Schön Klinik Berchtesgadener Land'}, 'officialTitle': 'Short and Medium-term Effects of Pulmonary Rehabilitation in Mild to Critical Post-acute COVID-19 - an Observational Trial', 'orgStudyIdInfo': {'id': 'COVID-Rehab'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'mild to moderate COVID 19', 'description': 'patients post-acute mild to moderate COVID 19', 'interventionNames': ['Other: pulmonary rehabilitation']}, {'label': 'severe to critical COVID 19', 'description': 'patients post-acute severe to critical COVID 19', 'interventionNames': ['Other: pulmonary rehabilitation']}], 'interventions': [{'name': 'pulmonary rehabilitation', 'type': 'OTHER', 'description': 'COVID 19 patients perform a standardized 3-week inpatient pulmonary rehabilitation program', 'armGroupLabels': ['mild to moderate COVID 19', 'severe to critical COVID 19']}]}, 'contactsLocationsModule': {'locations': [{'zip': '83471', 'city': 'Schönau am Königssee', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Schön Klinik Berchtesgadener Land', 'geoPoint': {'lat': 47.60055, 'lon': 12.98704}}], 'overallOfficials': [{'name': 'Andreas R Koczulla, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Philipps University Marburg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Schön Klinik Berchtesgadener Land', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Prof. Dr. Andreas Rembert Koczulla', 'investigatorAffiliation': 'Schön Klinik Berchtesgadener Land'}}}}