Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:49 AM
Study NCT ID:
NCT06679218
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-07
First Post:
2024-11-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improving Health Status in COVID-19 Long-Hauler
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-01-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-06', 'studyFirstSubmitDate': '2024-11-06', 'studyFirstSubmitQcDate': '2024-11-06', 'lastUpdatePostDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IPAQ (International Physical Activity Questionnaire)', 'timeFrame': 'Baseline and at 8 weeks at the end of the intervention'}, {'measure': 'EQ-5D (EuroQol-5 Dimensions)', 'timeFrame': 'Baseline and at 8 weeks at the end of the intervention'}, {'measure': 'PROMIS (Patient-Reported Outcomes Measurement Information System)', 'timeFrame': 'Baseline and at 8 weeks at the end of the intervention'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post COVID-19 Condition']}, 'descriptionModule': {'briefSummary': "This randomized clinical trial investigates the effects of a distance physical activity coaching program on the health of COVID-19 long-hauler. The study evaluates the impact of individualized coaching interventions to improve participants' physical activity and quality of life."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of both sexes.\n* Agreed to participate.\n* Post COVID-19 condition patients meeting the WHO definition for this disease.\n* Sedentary patients according to the cut-off point of the International Physical Activity Questionnaire (IPAQ).\n\nExclusion Criteria:\n\n* Pulmonary, cardiac, neurological, vascular, or orthopaedic pathologies that could limit the execution of the evaluation and intervention.\n* Cognitive impairment that prevented them from understanding and answering the questionnaires.\n* Patients suffering from a reinfection with SARS-CoV-2.\n* Patients with a history of severe or critical COVID-19 disease severity.\n* Patients participating in other studies.'}, 'identificationModule': {'nctId': 'NCT06679218', 'briefTitle': 'Improving Health Status in COVID-19 Long-Hauler', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Granada'}, 'officialTitle': 'Improving Health Status in COVID-19 Long-Hauler Through an Activity Coaching Programme: a Randomized Control Trial', 'orgStudyIdInfo': {'id': 'DF0102UG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Activity Coaching Programme', 'interventionNames': ['Other: Activity Coaching Programme']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard medical care and leaflet education', 'interventionNames': ['Other: Standard medical care and leaflet education']}], 'interventions': [{'name': 'Activity Coaching Programme', 'type': 'OTHER', 'description': "The intervention will consist of individualized physical activity coaching sessions, which will take place twice a week for 8 weeks. These sessions will focus on encouraging progressive and personalized physical activity according to each participant's ability. The sessions will also include relaxation techniques, targeted ventilation and strategies to improve activity management.", 'armGroupLabels': ['Activity Coaching Programme']}, {'name': 'Standard medical care and leaflet education', 'type': 'OTHER', 'description': 'In addition to standard medical care, patients assigned to this group received a leaflet with information about the main post COVID-19 condition symptoms. This is a control group that was not controlled or monitored by a therapist.', 'armGroupLabels': ['Standard medical care and leaflet education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18071', 'city': 'Granada', 'state': 'Granada', 'country': 'Spain', 'contacts': [{'name': 'Marie Carmen Valenza, PT', 'role': 'CONTACT', 'email': 'cvalenza@ugr.es', 'phone': '958 248035'}, {'name': 'Marie Carmen Valenza, PT, PhD', 'role': 'CONTACT'}], 'facility': 'Faculty of Health Sciences. University of Granada', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}], 'centralContacts': [{'name': 'Marie Carmen Valenza, PhD', 'role': 'CONTACT', 'email': 'cvalenza@ugr.es', 'phone': '958 248035'}], 'overallOfficials': [{'name': 'Marie Carmen Valenza, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad de Granada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Granada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Marie Carmen Valenza', 'investigatorAffiliation': 'Universidad de Granada'}}}}