Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-04-10 @ 5:29 AM
Study NCT ID:
NCT06480656
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eccentric Cycling Exercise During Pulmonary Rehabilitation Pulmonary Vascular Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-24', 'studyFirstSubmitDate': '2024-05-31', 'studyFirstSubmitQcDate': '2024-06-24', 'lastUpdatePostDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'peak exercise capacity', 'timeFrame': '3 weeks'}], 'secondaryOutcomes': [{'measure': 'Peak oxygen uptake', 'timeFrame': '3 weeks', 'description': 'Assesses during exercise until exhaustion using an incremental exercise protocol'}, {'measure': 'ventilatory equivalent for CO2', 'timeFrame': '3 weeks'}, {'measure': 'Finger pulseoximetry', 'timeFrame': '3 weeks', 'description': 'Arterial oxygen saturation will be assessed by finger clip Infrared spectroscopy'}, {'measure': '6 minute walk distance', 'timeFrame': '3 weeks'}, {'measure': 'systolic pulmonary artery pressure', 'timeFrame': '3 weeks'}, {'measure': 'total pulmonary resistance', 'timeFrame': '3 weeks'}, {'measure': 'ventricular - pulmonary arterial coupling', 'timeFrame': '3 weeks'}, {'measure': 'cardiac output', 'timeFrame': '3 weeks', 'description': 'will be assessed by echocardiography using the pulse-wave doppler technique at the left ventricular outflow tract durig systole.'}, {'measure': 'Arterial partial pressure for oxygen', 'timeFrame': '3 weeks', 'description': 'Arterial blood gas analyses, taken from the radial artery and analysed by radiometer'}, {'measure': 'Arterial partial pressure for carbon dioxide', 'timeFrame': '3 weeks', 'description': 'Arterial blood gas analyses, taken from the radial artery and analysed by radiometer'}, {'measure': 'Arterial oxygen saturation', 'timeFrame': '3 weeks', 'description': 'Arterial blood gas analyses, taken from the radial artery and analysed by radiometer'}, {'measure': 'Arterial lactate concentration', 'timeFrame': '3 weeks', 'description': 'Arterial blood gas analyses, taken from the radial artery and analysed by radiometer'}, {'measure': 'Borg CR 10 for perceived dyspnea', 'timeFrame': '3 weeks'}, {'measure': 'Borg CR 10 for perceived leg fatigue', 'timeFrame': '3 weeks'}, {'measure': 'Visual analogue scale generell well being', 'timeFrame': '3 weeks'}, {'measure': 'Visual analogue scale dyspnea', 'timeFrame': '3 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Eccentric Cycling Exercise']}, 'descriptionModule': {'briefSummary': 'Eccentric cycling allows high intensities with low metabolic costs. Therefore the aim of this project is to investigate whether ECC improves exercise capacity and possibly hemodynamics during prolonged rehabilitation programs in patients with PVD', 'detailedDescription': "Eccentric cycling exercise (ECC) allows training at low metabolic costs and may therefore be valuable for patients with pulmonary vascular disease (PVD). For these patients, regular exercise training has an evidence level 1A recommendation in the current guidelines. Exercise training during longer and regular periods provides chronic adaptation, for which ECC was recently found to have a greater effectiveness than CON by increasing muscle strength, hypertrophy, six-minute walking distance and furthermore, by increasing maximum oxygen uptake (V'O2max) especially in patients with chronic obstructive pulmonary disease (COPD), chronic left heart failure or coronary heart disease.\n\nFurthermore, the investigators conducted an RCT in which the investigators exposed patients with PVD to ECC and concluded that ECC is a feasible and well-tolerated exercise modality for PVD patients with severely lower O2 demand and load to the right ventricle.\n\nTherefore the aim of this project is to investigate whether ECC improves exercise capacity and possibly hemodynamics during prolonged rehabilitation programs in patients with PVD."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with PVD, either PAH or CTEPH according to recent guidelines\n* Stable medication for at least 1 month\n* Age 18 to 85 years\n* No resting hypoxemia (PaO2 \\>7.3kPa)\n\nExclusion Criteria:\n\n* Any co-morbidity that limits the patient to participate the full rehabilitation\n* Enrollments in other trials with active treatments'}, 'identificationModule': {'nctId': 'NCT06480656', 'briefTitle': 'Eccentric Cycling Exercise During Pulmonary Rehabilitation Pulmonary Vascular Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Eccentric Cycling Exercise During Pulmonary Rehabilitation in Pulmonary Vascular Disease', 'orgStudyIdInfo': {'id': 'EccRehab'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Eccentric cycling exercise', 'interventionNames': ['Procedure: Rehabilitation with eccentric cycling exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Concentric cycling exercise', 'interventionNames': ['Procedure: normal rehabilitation']}], 'interventions': [{'name': 'Rehabilitation with eccentric cycling exercise', 'type': 'PROCEDURE', 'description': 'Instead of normal cycling, patients will exercise on the eccentric bike.', 'armGroupLabels': ['Eccentric cycling exercise']}, {'name': 'normal rehabilitation', 'type': 'PROCEDURE', 'description': 'Normal rehabilitation will be conducted', 'armGroupLabels': ['Concentric cycling exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5017', 'city': 'Erlinsbach', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Thomas Sidrist, md', 'role': 'CONTACT', 'email': 'info@barmelweid.ch', 'phone': '062 857 21 11'}], 'facility': 'Rehabilitation clinic Barmelweid', 'geoPoint': {'lat': 47.39753, 'lon': 8.00797}}, {'city': 'Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Silvia Ulrich Somaini, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Florian Hildenbrand, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital Zurich, Pneumology', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Silvia Ulrich, Prof', 'role': 'CONTACT', 'email': 'silvia.ulrich@usz.ch', 'phone': '0442564362'}, {'name': 'Julian Müller, Msc', 'role': 'CONTACT', 'email': 'Julian.Mueller2@usz.ch', 'phone': '0432539349'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med.', 'investigatorFullName': 'Silvia Ulrich Somaini', 'investigatorAffiliation': 'University of Zurich'}}}}