Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-27 @ 4:33 AM
Study NCT ID:
NCT07042750
Status:
RECRUITING
Last Update Posted:
2025-06-29
First Post:
2025-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eccentric Cycling Exercise During Pulmonary Rehabilitation in Patients With Cardiopulmonary Diseases
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': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Intervention: Eccentric cycling (instead of usual cycling) + standard care Control: Standard care'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-19', 'studyFirstSubmitDate': '2025-06-10', 'studyFirstSubmitQcDate': '2025-06-19', 'lastUpdatePostDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak exercise performance [Watts]', 'timeFrame': 'At baseline pre-intervention and immediately after three weeks of rehabilitation', 'description': 'Peak exercise performance is measured during cardiopulmonary exercise tests on a cycle ergometer. The Unit of the measurement is watts.'}], 'secondaryOutcomes': [{'measure': 'Peak oxygen uptake [L/min]', 'timeFrame': 'At baseline pre-intervention and immediately after three weeks of rehabilitation', 'description': 'Peak oxygen uptake is measured during cardiopulmonary exercise tests on a cycle ergometer. The Unit of the measurement is liters per minute.'}, {'measure': 'Ventilatory equivalents for carbon dioxide (Minute ventilation / carbon dioxide output)', 'timeFrame': 'At baseline pre-intervention and immediately after three weeks of rehabilitation', 'description': 'Ventilatory equivalents for carbon dioxide is measured during cardiopulmonary exercise tests on a cycle ergometer. The measurement is a ratio without a unit (VE/VCO2).'}, {'measure': 'Six minute walk distance [meters]', 'timeFrame': 'At baseline pre-intervention and immediately after three weeks of rehabilitation', 'description': 'The maximal distance that a patient is able to walk within six minutes. The unit of the measurement is meters.'}, {'measure': 'Knee extension test [repetitions]', 'timeFrame': 'At baseline pre-intervention and immediately after three weeks of rehabilitation', 'description': 'The patients has to stad up from a chair and sit down as often the patient is able to do this within 1 minute. The unit of the measurement is repetitions.'}, {'measure': 'Systolic pulmonary arterial pressure [mmHg]', 'timeFrame': 'At baseline pre-intervention and immediately after three weeks of rehabilitation', 'description': 'The sytolic pulmonary arterial pressure is measured by echocardiography using continuous wave doppler at the tricuspid valve. The unit of the measurement is mmHg.'}, {'measure': 'Total pulmonary reistance [Wood units]', 'timeFrame': 'At baseline pre-intervention and immediately after three weeks of rehabilitation', 'description': 'The total pulmonary resistance is measured by echocardiography by dividing the systolic pulmonary arterial pressure by the cardiac output. The unit of the measurement is woos units.'}, {'measure': 'Right ventricular to arterial coupling [mm/mmHg]', 'timeFrame': 'At baseline pre-intervention and immediately after three weeks of rehabilitation', 'description': 'The right ventricular arterial coupling is measured by echocardiography dividing the tricuspid annular plane systolic excursion by the systolic arterial pressure. the unit is mm/mmHg.'}, {'measure': 'Cardiac output [L/min]', 'timeFrame': 'At baseline pre-intervention and immediately after three weeks of rehabilitation', 'description': 'The cardiac output is measured by echocardiography using the left ventricular outflow tract velocity time integral assessed by pulse wave doppler. The unit of the measurement is L/min.'}, {'measure': 'Arterial partial pressure for oxygen [kPa]', 'timeFrame': 'At baseline pre-intervention and immediately after three weeks of rehabilitation', 'description': 'The arterial partial pressure for oxygen is measured by taking a arterial blood sample from the arteria radialis at peak exercise and analyze it in a radiometer. The unit of the measurement is kPa.'}, {'measure': 'Arterial partial pressure for carbon dioxide [kPa]', 'timeFrame': 'At baseline pre-intervention and immediately after three weeks of rehabilitation', 'description': 'The arterial partial pressure for carbon dioxide is measured by taking a arterial blood sample from the arteria radialis at peak exercise and analyze it in a radiometer. The unit of the measurement is kPa.'}, {'measure': 'Arterial oxygen saturation [%]', 'timeFrame': 'At baseline pre-intervention and immediately after three weeks of rehabilitation', 'description': 'The arterial oxygen saturation is measured by taking a arterial blood sample from the arteria radialis at peak exercise and analyze it in a radiometer. The unit of the measurement is %.'}, {'measure': 'Patient reported leg fatigue [scale from 1 to 10]', 'timeFrame': 'At baseline pre-intervention and immediately after three weeks of rehabilitation', 'description': 'Patients perceived leg fatigue is assessed at peak exercise on the Borg CR 10 scale. The unit of the measurement is a scale from 1 to 10.'}, {'measure': 'Patient reported dyspnea [scale from 1 to 10]', 'timeFrame': 'At baseline pre-intervention and immediately after three weeks of rehabilitation', 'description': 'Patients perceived dyspnea is assessed at peak exercise on the Borg CR 10 scale. The unit of the measurement is a scale from 1 to 10.'}, {'measure': 'Patient reported quality of life [cm]', 'timeFrame': 'At baseline pre-intervention and immediately after three weeks of rehabilitation', 'description': 'The patient reported quality of life is assessed by the visual analogue scale, where the patient has to draw on a 10 cm long line where left is "bad" and right is "very good". The unit of the measurement is cm.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Eccentric cycling exercise', 'Pulmonary rehabilitation'], 'conditions': ['Eccentric Exercise Training']}, 'descriptionModule': {'briefSummary': "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. Furthermore, we conducted an RCT in which we 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. The study in patients with PVD was started (EccRehab), and the great potential was recognized. Therefore there was an indication to open the inclusion criteria to all cardiopulmonary patients with indication for pulmonary rehabilitation (EccRehab2).\n\nFor this purpose, the aim of this project is to investigate whether ECC improves exercise capacity and possibly hemodynamics during prolonged rehabilitation programs in patients with cardiopulmonary diseases."}, '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 via right heart catheterization, according to recent guidelines \\[9\\]\n* Diagnosed with a cardiopulmonary disease as indication for a pulmonary rehabilitation\n* Stable medication for at least 1 month\n* Age 18years to 85 years\n* No resting hypoxemia (PaO2 \\>7.3 kPa)\n* Medical indication to prescibe a pulmonary rehabilitation\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\n* Language barriers that limits the patient to participate in the rehabilitation'}, 'identificationModule': {'nctId': 'NCT07042750', 'briefTitle': 'Eccentric Cycling Exercise During Pulmonary Rehabilitation in Patients With Cardiopulmonary Diseases', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Eccentric Cycling Exercise During Pulmonary Rehabilitation in Patients With Cardiopulmonary Diseases', 'orgStudyIdInfo': {'id': 'EccRehab2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Eccentric cycling', 'description': 'Patients perform eccentric cycling exercise instead of normal cycling exercise in addition to standard car during a cardiopulmonary rehabilitation', 'interventionNames': ['Other: Eccentric cycling exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard care', 'description': 'Patients perform cardiopulmonary rehabilitation according to standard care', 'interventionNames': ['Other: Standard Care Arm']}], 'interventions': [{'name': 'Eccentric cycling exercise', 'type': 'OTHER', 'description': 'Patients perform eccentric cycling exercise instead of normal cycling exercise in addition to standard car during a cardiopulmonary rehabilitation', 'armGroupLabels': ['Eccentric cycling']}, {'name': 'Standard Care Arm', 'type': 'OTHER', 'description': 'Patients perform cardiopulmonary rehabilitation according to standard care', 'armGroupLabels': ['Standard care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5017', 'city': 'Barmelweid', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Thomas Sigrist, Dr. med.', 'role': 'CONTACT', 'email': 'thomas.sigrist@barmelweid.ch', 'phone': '062 857 20 00'}], 'facility': 'Klinik Barmelweid', 'geoPoint': {'lat': 47.41588, 'lon': 7.9764}}, {'zip': '8092', 'city': 'Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Silvia Ulrich, Prof. dr. med.', 'role': 'CONTACT', 'email': 'silvia.ulrich@usz.ch', 'phone': '0432539349'}, {'name': 'Julian Müller, Dr. sc. med.', 'role': 'CONTACT', 'email': 'julian.mueller2@usz.ch'}], 'facility': 'Universitätsspital Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Silvia Ulrich, Prof. dr. med.', 'role': 'CONTACT', 'email': 'silvia.ulrich@usz.ch', 'phone': '+41442564362'}, {'name': 'Julian Müller, Dr. sc. med.', 'role': 'CONTACT', 'email': 'julian.mueller2@usz.ch', 'phone': '0432539349'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Silvia Ulrich Somaini', 'class': 'OTHER'}, 'collaborators': [{'name': 'Klinik Barmelweid', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof. Silvia Ulrich', 'investigatorFullName': 'Silvia Ulrich Somaini', 'investigatorAffiliation': 'University of Zurich'}}}}