Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-02-22 @ 7:24 AM
Study NCT ID:
NCT02575469
Status:
NOT_YET_RECRUITING
Last Update Posted:
2017-01-24
First Post:
2015-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Capacity in Diseases and Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2036-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-23', 'studyFirstSubmitDate': '2015-10-12', 'studyFirstSubmitQcDate': '2015-10-12', 'lastUpdatePostDateStruct': {'date': '2017-01-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2035-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VO2 (oxygen consumption)', 'timeFrame': '30 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Exercise Capacity']}, 'descriptionModule': {'briefSummary': 'Exercise capacity is a key factor to evaluate and treat patients in different diseases (e.g. ischemic heart disease, chronic obstructive pulmonary disease, cystic fibrosis). The best way to measure exercise capacity is to perform a cardiopulmonary exercise testing. Normal/reference values in health and disease relate to specific population and subpopulations. The population in Israel is unique in its diversity.\n\nObjectives: Data collection of exercise capacity assessment in health and illness in the northern of Israel for future local database.\n\nPopulation: 500 Patients evaluated routinely in the exercise lab (pediatric cardiology institute) and healthy volunteers evaluated as controls.\n\nStudy design: Prospective observational study. Participants will answer a health related questioner, undergo a physical examination, perform a cardiopulmonary exercise test on a treadmill or a cycle ergometer.', 'detailedDescription': 'Exercise capacity is a key factor to evaluate and treat patients in different diseases (e.g. ischemic heart disease, chronic obstructive pulmonary disease, cystic fibrosis). The best way to measure exercise capacity is to perform a cardiopulmonary exercise testing. Normal/reference values in health and disease relate to specific population and subpopulations. The population in Israel is unique in its diversity.\n\nObjectives: Data collection of exercise capacity assessment in health and illness in the northern of Israel for future local database.\n\nPopulation: 500 Patients evaluated routinely in the exercise lab (pediatric cardiology institute) and healthy volunteers evaluated as controls.\n\nStudy design: Prospective observational study. Participants will answer a health related questioner, undergo a physical examination, perform a cardiopulmonary exercise test on a treadmill or a cycle ergometer .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '6 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '500 Patients evaluated routinely in the exercise lab (pediatric cardiology institute) and healthy volunteers evaluated as controls.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to complete full exercise evaluation (including cardiopulmonary exercise testing).\n\nExclusion Criteria:\n\n* Acute illness on visit day.\n* for healthy volunteers: chronic disease or use of medications.\n* Professional athletes.'}, 'identificationModule': {'nctId': 'NCT02575469', 'briefTitle': 'Exercise Capacity in Diseases and Health', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Exercise Capacity in Diseases and Health', 'orgStudyIdInfo': {'id': '0323-14- RMB-CTIL'}}, 'contactsLocationsModule': {'locations': [{'zip': '31096', 'city': 'Haifa', 'country': 'Israel', 'facility': 'RAMBAM health care center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'centralContacts': [{'name': 'Abraham Lorber, MD', 'role': 'CONTACT', 'email': 'a_lorber@rambam.health.gov.il', 'phone': '+972-4-7774630'}, {'name': 'Ronen Bar-Yoseph, MD', 'role': 'CONTACT', 'email': 'ronenfabi@gmail.com', 'phone': '+972-4-777-4304'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of pediatric cardiology institute, Ruth children hospital', 'investigatorFullName': 'Prof. Avraham Lorber', 'investigatorAffiliation': 'Rambam Health Care Campus'}}}}