Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-01-05 @ 1:20 AM
Study NCT ID:
NCT04153669
Status:
COMPLETED
Last Update Posted:
2020-07-24
First Post:
2019-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise With or Without Electrical Stimulation in Cystic Fibrosis (Part I): Effects on Physical Fitness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-03-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-23', 'studyFirstSubmitDate': '2019-10-30', 'studyFirstSubmitQcDate': '2019-11-03', 'lastUpdatePostDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Strength', 'timeFrame': 'Two assessment points throughout the study: baseline and 8 weeks after the intervention', 'description': 'Changes in strength will be measured using a five repetition maximum test (5RM)'}], 'secondaryOutcomes': [{'measure': 'Change in Cardiorespiratory Fitness', 'timeFrame': 'Two assessment points throughout the study:baseline and 8 weeks after the intervention', 'description': 'Changes in cardiorespiratory fitness will be measured using a cardiopulmonary exercise test (CPET)'}, {'measure': 'Changes in Pulmonary Function', 'timeFrame': 'Two assessment points throughout the study:baseline and 8 weeks after the intervention', 'description': 'Changes in pulmonary function will be measured using Spirometry'}, {'measure': 'Changes in physical activity levels', 'timeFrame': 'Two assessment points throughout the study:baseline and 8 weeks after the intervention', 'description': 'Changes in physical activity levels will be measured using Physical Activity Questionnaire for Children and Adolescents (PAC-C or PAC-A)'}, {'measure': 'Change in quality of life', 'timeFrame': 'Two assessment points throughout the study:baseline and 8 weeks after the intervention', 'description': 'Changes in quality of life will be measures with the Cystic Fibrosis-Questionnaire-Revised (CFQ-R)'}, {'measure': 'Food consumption frequency', 'timeFrame': 'One assessment point at baseline:baseline and 8 weeks after the intervention', 'description': 'The food consumption frequency will be measured using food frequency questionnaire (FFQ)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cystic Fibrosis', 'Electrostimulation', 'Combined Training', 'Physical Fitness'], 'conditions': ['Cystic Fibrosis in Children']}, 'descriptionModule': {'briefSummary': 'This study aims to assess the effects of programmed exercise with or without electrical stimulation in the cardiorespiratory fitness, strength, functional capacity and agility in a group of young patients with Cystic Fibrosis: A randomized controlled trial comparing two interventions with a control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of CF\n* Age: 6-18 years old\n* Signature of informed consent of legal guardian and patient.\n\nExclusion Criteria:\n\n* Being a smoker\n* Having had an exacerbation in the last 3 months\n* Having undergone gastric surgery\n* Having enteral nutrition at present\n* The patients will come from the HIUNJ of Madrid.\n* Currently taking CFTR modulators'}, 'identificationModule': {'nctId': 'NCT04153669', 'acronym': 'ECOMIRIN', 'briefTitle': 'Exercise With or Without Electrical Stimulation in Cystic Fibrosis (Part I): Effects on Physical Fitness', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Europea de Madrid'}, 'officialTitle': 'Effects of Exercise With or Without Electrical Stimulation in Physical Fitness in Cystic Fibrosis: an Integrated Vision (ECOMIRIN Study)', 'orgStudyIdInfo': {'id': 'R-0019/18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'This group will continue with regular visits to the specialist. This visits include recommendations to improve lifestyle.'}, {'type': 'EXPERIMENTAL', 'label': 'Exercise-No NMES', 'description': 'This group will continue with regular visits to the specialist. This visits include recommendations to improve lifestyle.\n\nThe exercise protocol includes a concurrent exercise intervention (strength training and aerobic training), 3 days a week, 60 minutes sessions.', 'interventionNames': ['Behavioral: Exercise-No NMES']}, {'type': 'EXPERIMENTAL', 'label': 'Exercise-NMES', 'description': 'This group will continue with regular visits to the specialist. This visits include recommendations to improve lifestyle.\n\nThe exercise protocol includes a concurrent exercise intervention (strength training and aerobic training), 3 days a week, 60 minutes sessions. Additionally, this group will receive neuromuscular electrical stimulation (NMES) concomitant to the strength training.', 'interventionNames': ['Behavioral: Exercise-NMES']}], 'interventions': [{'name': 'Exercise-NMES', 'type': 'BEHAVIORAL', 'description': 'Exercise-NMES', 'armGroupLabels': ['Exercise-NMES']}, {'name': 'Exercise-No NMES', 'type': 'BEHAVIORAL', 'description': 'Exercise-No NMES', 'armGroupLabels': ['Exercise-No NMES']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28670', 'city': 'Villaviciosa de Odón', 'country': 'Spain', 'facility': 'Escuela de Doctorado e Investigacion, Universidad Europea', 'geoPoint': {'lat': 40.3581, 'lon': -3.9043}}], 'overallOfficials': [{'name': 'Margarita Perez Ruiz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Europea de Madrid'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Europea de Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor in Exercise Physiology, MD, PhD', 'investigatorFullName': 'Margarita Perez', 'investigatorAffiliation': 'Universidad Europea de Madrid'}}}}