Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-03-09 @ 2:44 AM
Study NCT ID:
NCT02951494
Status:
COMPLETED
Last Update Posted:
2022-05-25
First Post:
2016-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Lower Body Weight Support Treadmill on Cardiopulmonary Exercise Capacity and Trainability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-18', 'studyFirstSubmitDate': '2016-10-12', 'studyFirstSubmitQcDate': '2016-10-28', 'lastUpdatePostDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximal oxygen consumption', 'timeFrame': '12 weeks', 'description': 'VO2peak \\[ml/min\\]'}], 'secondaryOutcomes': [{'measure': 'Oxygen consumption at anaerobic threshold', 'timeFrame': '12 weeks', 'description': 'VO2@AT'}, {'measure': 'Pulse wave velocity', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'referencesModule': {'references': [{'pmid': '32053417', 'type': 'DERIVED', 'citation': 'Brussau T, Oehring R, Felix SB, Dorr M, Bahls M. Cardiorespiratory and metabolic responses to exercise testing during lower-body positive pressure running. J Appl Physiol (1985). 2020 Apr 1;128(4):778-784. doi: 10.1152/japplphysiol.00328.2019. Epub 2020 Feb 13.'}]}, 'descriptionModule': {'briefSummary': 'The AlterG®-anti-gravity treadmill provides lower body weight support which enables individuals to exercise without feeling their full body weight. How this body weight support influences cardiovascular, respiratory, vascular and metabolic parameters is currently unclear. Further, whether body weight support influences the trainability in response to moderate continuous exercise is unknown. This investigation has two main goals. First, we explore the direct influence of lower body weight support on cardiometabolic parameters during maximal exercise testing. Second, we aim to compare changes in cardiorespiratory fitness in response to a structured exercise protocol using moderate intensity with and without lower body weight support.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* maximal oxygen consumption below age-sex specific standard\n\nExclusion Criteria:\n\n* acute infection within the last four weeks\n* anemia (males: Hb \\< 8.1 mmol/L; females Hb \\< 7.4 mmol/L)\n* previous reports of myo-, endo, or pericarditis\n* previous stroke or acute myocardial infarction\n* heart failure (NYHA \\> 1)\n* aortic valve stenosis\n* congenital heart disease\n* cardiomyopathy\n* severe left ventricular hypertrophy\n* cardiac arrythmias\n* hypertension\n* diabetes\n* BMI \\> 35\n* cancer\n* pregnancy\n* aneurysm of aorta or cerebral arteries'}, 'identificationModule': {'nctId': 'NCT02951494', 'briefTitle': 'Impact of Lower Body Weight Support Treadmill on Cardiopulmonary Exercise Capacity and Trainability', 'organization': {'class': 'OTHER', 'fullName': 'University Medicine Greifswald'}, 'officialTitle': 'Einfluss Der Körpergewichtsunterstützung Auf Einem AlterG®-Antigravitationslaufband Auf Die Kardiopulmonale Leistungsfähigkeit Und Trainierbarkeit', 'orgStudyIdInfo': {'id': 'AlterG-Training-I Studie'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'AlterG Anti-gravity treadmill', 'description': 'cont. aerobic exercise training with lower body weight support', 'interventionNames': ['Other: AlterG Anti-gravity treadmill']}, {'type': 'NO_INTERVENTION', 'label': 'Exercise without body weight support', 'description': 'cont. aerobic exercise training without lower body weight support'}], 'interventions': [{'name': 'AlterG Anti-gravity treadmill', 'type': 'OTHER', 'description': 'Participants in this group will complete a 12 week aerobic exercise training protocol with 40% lower body weight support on an AlterG Anti-gravity treadmill', 'armGroupLabels': ['AlterG Anti-gravity treadmill']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17489', 'city': 'Greifswald', 'country': 'Germany', 'facility': 'Cardiovascular examination center of the University Medicine Greifswald', 'geoPoint': {'lat': 54.08905, 'lon': 13.40244}}], 'overallOfficials': [{'name': 'Marcus Dörr, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medicine Greifswald'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medicine Greifswald', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}