Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-01-01 @ 2:04 AM
Study NCT ID:
NCT04961333
Status:
UNKNOWN
Last Update Posted:
2021-07-14
First Post:
2021-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internet-based Multidisciplinary Rehabilitation for Longterm COVID-19 Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094024', 'term': 'Post-Acute COVID-19 Syndrome'}, {'id': 'D000086382', 'term': 'COVID-19'}], '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'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Intervention group and waiting list control group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-12', 'studyFirstSubmitDate': '2021-05-07', 'studyFirstSubmitQcDate': '2021-07-12', 'lastUpdatePostDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in health-related quality of life measured by Short Form-36', 'timeFrame': 'Investigators expect changes at 6 months follow-up after rehabilitation', 'description': 'Important sub scales: vitality, general health, physical functioning, pain. Scale varies between 0 and 100 (highest)'}, {'measure': 'Changes in heart rate variability during physical tests', 'timeFrame': 'Investigators expect normalisation at 6 months follow-up', 'description': 'Heart rate variability measured by puls oximeter during 2 physical tests'}], 'secondaryOutcomes': [{'measure': 'Overall changed scores in validated questionnaires for fatigue, breathing, pain and sleep disorders', 'timeFrame': 'Investigators expect changes already at 6 months follow-up', 'description': 'Validated self-scored questionnaires such as Multidimentional Fatigue Inventory - for fatigue (values 0-20), Clinical COPD Questionnaire - for breathing (0-50), Chronic Visual Analogue Scale - for pain (0-100), Insomnia Severity Scale - for sleep (0-21) and other questionnaires.'}, {'measure': 'Changed functioning and activity', 'timeFrame': 'Investigators expect normalisation at 6 months follow-up', 'description': 'Functioning and activity will be evaluated by self-scored questionnaires and a new questionnaire Functional compass for COVID-19 based on ICF (International Classification of Functioning and Disability)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'rehabilitation', 'telemedicine', 'multidisciplinary'], 'conditions': ['Long COVID-19']}, 'descriptionModule': {'briefSummary': 'Internet-based multidisciplinary interventions will be offered to participants suffering from longterm COVID-19 syndrome. Data will be collected by internet platform at Karolinska Institutet (BASS) before, after rehabilitation and at follow-up after 6 months. Both self-scored questionnaires and physical tests performed at home will be collected to understand the symptomatology, functioning and activity level. Rehabilitation during 8 weeks period will be given in groups as face-to-group, pre-recorded film sessions and by individual approach, the participants will use ExorLive app for physical activity.', 'detailedDescription': 'This randomised study aimed to understand if multidisciplinary internet-based interventions performed in group and individually are applicable for participants suffering from longterm COVID-19 syndrome. Data will be collected by internet platform at Karolinska Institutet (BASS) before, after rehabilitation and at follow-up after 6 months. Both self-scored questionnaires and physical tests performed at home will be collected to understand the symptomatology, functioning and activity level. Rehabilitation during 8 weeks period will be given in groups as face-to-group, pre-recorded film sessions and by individual approach, the participants will use ExorLive app for physical activity.\n\nThe participants will be randomised for treatment and waiting lists using a website random.org. Waiting list will be offered rehabilitation interventions after at least 8 weeks period of waiting to exclude a spontaneous improvement or worsening of symptoms. To understand the impact of rehabilitation on work capacity and employment/economic supply, the data from Social Insurance databas will be obtained 2021 year before and upp to 2 years after the intervention. To understand the impact of rehabilitation on sickness-leave, the data from National Insurance Agency will be obtained for 2021 and 2022.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '67 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* confirmed COVID-19 infection\n* post-infection symptoms lasting longer than 3-6 months\n* clinically stable persons regarding symtoms or other co-morbidities\n* ability to participate in internet-based rehabilitation in group in Swedish.\n\nExclusion Criteria:\n\n* uncertainty regarding covid-19 infection or co-morbidities started or exacerbated during the same time\n* alcohol and drug abuse\n* untreated psychiatric and somatic co-morbidities\n* undergoing medical or psychotherapeutic treatment or rehabilitation which can interact with rehabilitation outcomes.'}, 'identificationModule': {'nctId': 'NCT04961333', 'acronym': 'COVID-19', 'briefTitle': 'Internet-based Multidisciplinary Rehabilitation for Longterm COVID-19 Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Danderyd Hospital'}, 'officialTitle': 'Internet-based Multidisciplinary Rehabilitation for Longterm COVID-19 Syndrome', 'orgStudyIdInfo': {'id': 'Danderyd University Hospital'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rehabilitation group', 'description': 'Rehabilitation group will be provided multidisciplinary interventions online and individually by ExorLive app. The screening with self-scored questionnaires and physical tests will be performed before and after 8 weeks rehabilitation.', 'interventionNames': ['Behavioral: Multidisciplinary Rehabilitation']}, {'type': 'NO_INTERVENTION', 'label': 'Waiting list controls', 'description': 'Passive waiting list or control group, which will be offered to participate in rehabilitation after at least 8 weeks of waiting time. The group will fulfil screening twice, following the time schedule of intervention group. When invited to rehabilitation a new screening will be asked to be completed if the waiting time after the last screening will be longer than 2 weeks.'}], 'interventions': [{'name': 'Multidisciplinary Rehabilitation', 'type': 'BEHAVIORAL', 'otherNames': ['Individually performed physical activity recorded into ExorLie app.'], 'description': 'Body therapies to improve breathing, normalise dysfunction in the autonomic nervous system, relaxation, mindfulness, in some part Acceptance and Commitment Therapy given preferably through body therapies.', 'armGroupLabels': ['Rehabilitation group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '112 19', 'city': 'Stockholm', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Indre Bileviciute-Ljungar, Associated professor', 'role': 'CONTACT', 'email': 'indre.ljungar@ki.se', 'phone': '+46858703158'}, {'name': 'Kristian Borg, professor', 'role': 'CONTACT', 'email': 'kristian.borg@ki.se', 'phone': '+46812355000'}], 'facility': 'St Göran Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'centralContacts': [{'name': 'Indre Bileviciute-Ljungar, Associated professor', 'role': 'CONTACT', 'email': 'indre.ljungar@ki.se', 'phone': '+46858703158'}, {'name': 'Kristian Borg, professor', 'role': 'CONTACT', 'email': 'kristian.borg@ki.se', 'phone': '+46812355000'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danderyd Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'St Göran Hospital, Stockholm', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associated professor in rehabilitation medicine', 'investigatorFullName': 'Indre Ljungar', 'investigatorAffiliation': 'Danderyd Hospital'}}}}