Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2026-02-19 @ 12:21 AM
Study NCT ID:
NCT04150003
Status:
UNKNOWN
Last Update Posted:
2021-01-14
First Post:
2019-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on the Effect of a Physical Training Structured Program After a Pulmonary Thromboembolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011655', 'term': 'Pulmonary Embolism'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012046', 'term': 'Rehabilitation'}], 'ancestors': [{'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 144}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-12', 'studyFirstSubmitDate': '2019-10-22', 'studyFirstSubmitQcDate': '2019-10-31', 'lastUpdatePostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the rate of lung perfusion defects after PE', 'timeFrame': 'Baseline up to one month after the episode of PE, final after 12 weeks of randomization', 'description': 'Lung scintigraphy of lung perfusion'}], 'secondaryOutcomes': [{'measure': 'Identification of biomarkers of response to treatment', 'timeFrame': 'The day the randomization occurs and the final visit after 12 weeks of the randomization', 'description': 'Changes from baseline in the determination of mRNAs'}, {'measure': 'Identification of another biomarkers of response to treatment', 'timeFrame': 'The day the randomization occurs and the final visit after 12 weeks of the randomization', 'description': 'Changes from baseline in the determination of MPs (Microparticle (MP) Microparticles (MPs)'}, {'measure': 'Change in the percent predicted peak oxygen uptake (VO2 peak) after PE', 'timeFrame': 'Baseline up to one month after the episode of PE, final after 12 weeks of randomization', 'description': 'Peak Oxygen uptake (VO2 peak) is obtained from Cardiopulmonary Exercise Test'}, {'measure': 'Change in the EuroQol scale', 'timeFrame': 'Baseline up to one month after the episode of PE, final after 12 weeks of randomization', 'description': 'Visual analog score (0-100, lower score indicate worse outcome)'}, {'measure': 'Change in the PEmb-QoL questionnaire by a PEmb-QoL -', 'timeFrame': '"Baseline up to one month after the episode of PE, final after 12 weeks of randomization', 'description': 'PEmb-QoL summary score (0-100, higher score indicate worse outcome)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Venous Thromboembolic Disease', 'Pulmonary Embolism', 'Rehabilitation program', 'Exercise training'], 'conditions': ['Pulmonary Embolism']}, 'descriptionModule': {'briefSummary': 'Exercise training, as the core component of a Pulmonary Rehabilitation program, may help restore arterial blood flow in the lungs of patients who had suffered Pulmonary Embolism (PE), stimulating and promoting vasodilator effects, repairing the damaged endothelium and recruiting new blood vessels and also inducing a net fibrinolytic balance. Besides, exercise training could have a positive effect on quality of life of these patients.', 'detailedDescription': 'An experimental multicenter study is proposed , randomized according to parallel assignation and blinded to third ones to evaluate the effect of a 10-weeks structured exercise-based intervention protocol on the restoration of lung blood flow after an acute PE.\n\nMain objective is to compare the efficacy and safety in terms of quantitative measures from lung scintigraphy, of lung perfusion versus usual care in patients with PE. Additionally the study is aimed to identify bio-markers of response to treatment (mRNAs, MPs and proteomic approach) and to analyze the effects of training on exercise capacity, quality of life parameters and anxiety depression scores.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients 18 years or older at PE diagnosis PE diagnosis confirmed by imaging tests according guidelines Patients under correct anticoagulant treatment Persistent Lung Perfusion Defects at one month after PE diagnosis. Signed Consent Inform\n\nExclusion Criteria:\n\nIncidental or silent PE Pregnant or puerperal woman Life expectancy less than 6 months Severe comorbidities (NYHA 4 in severe heart failure; COPD, gold D; severe psychiatric illness) Any disability for physical exercise according to their doctors\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04150003', 'acronym': 'TEP-RR', 'briefTitle': 'Study on the Effect of a Physical Training Structured Program After a Pulmonary Thromboembolism', 'organization': {'class': 'OTHER', 'fullName': 'Fundación Pública Andaluza para la gestión de la Investigación en Sevilla'}, 'officialTitle': 'Multicenter, Randomize Study to Evaluate the Effect of a Physical Training Structured Program After a Pulmonary Thromboembolism in the Restoration Lung Perfusion', 'orgStudyIdInfo': {'id': 'TEP-RR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pulmonary Rehabilitation program', 'description': '10-weeks structured exercise-based intervention protocol on the restoration of lung blood flow after an acute PE', 'interventionNames': ['Behavioral: Pulmonary Rehabilitation program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care', 'description': 'Protocolized usual care for patient suffering PE', 'interventionNames': ['Other: Usual care']}], 'interventions': [{'name': 'Pulmonary Rehabilitation program', 'type': 'BEHAVIORAL', 'otherNames': ['Rehabilitation program'], 'description': 'Structured rehabilitation program of directed exercises', 'armGroupLabels': ['Pulmonary Rehabilitation program']}, {'name': 'Usual care', 'type': 'OTHER', 'description': 'Usual care for patients who had suffered a Pulmonary Embolism', 'armGroupLabels': ['Usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01009', 'city': 'Vitoria-Gasteiz', 'state': 'Alava', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'José Luis Lobo, MD', 'role': 'CONTACT', 'email': 'joseluis.loboberistain@osakidetza.eus'}], 'facility': 'Hospital de Txagorritxu', 'geoPoint': {'lat': 42.84998, 'lon': -2.67268}}, {'zip': '41013', 'city': 'Seville', 'state': 'Andalusia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Remedios Otero, MD', 'role': 'CONTACT', 'email': 'remeotero@gmail.com'}, {'name': 'Pilar Cejudo', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Teresa Elias', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Isabel Asencio', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Verónica Sánchez', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Joaquin Ruiz', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Luis Caballero', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital Universitario Virgen del Rocio', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '41009', 'city': 'Seville', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Virginia Almadana', 'role': 'CONTACT'}, {'name': 'Gertrudis Sabadell', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Patricia Guerrero', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Maria Isabel Blasco', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mercedes Vaquero', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yolanda López', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital Universitario Virgen Macarena', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'centralContacts': [{'name': 'Remedios Otero, Md-PHd', 'role': 'CONTACT', 'email': 'remeotero@gmail.com', 'phone': '0034955012144'}, {'name': 'Clara Rosso-Fernández, MD-PhD', 'role': 'CONTACT', 'email': 'claram.rosso.sspa@juntadeandalucia.es', 'phone': '0034955012144'}], 'overallOfficials': [{'name': 'Remedios Otero, MD-PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospitales Universitarios Virgen del Rocío'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'After the end of analysis and publication of results', 'ipdSharing': 'YES', 'description': 'Results to be published in impact factor journals', 'accessCriteria': 'collaborators in the design and performance of the study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Pública Andaluza para la gestión de la Investigación en Sevilla', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}