Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2026-03-02 @ 6:23 PM
Study NCT ID:
NCT04244305
Status:
UNKNOWN
Last Update Posted:
2020-01-29
First Post:
2019-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endurance Training in Patients Undergoing Lung Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005081', 'term': 'Exercise Therapy'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Assessors were blinded to group allocation of the participants'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-27', 'studyFirstSubmitDate': '2019-12-27', 'studyFirstSubmitQcDate': '2020-01-27', 'lastUpdatePostDateStruct': {'date': '2020-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6 Minute Walk Test', 'timeFrame': '1 month', 'description': 'Distance covered during the 6 Minute Walk Test performed according to the American Thoracic Guidelines.'}], 'secondaryOutcomes': [{'measure': '6 Minute Walk Test', 'timeFrame': '3 Months', 'description': 'Distance covered with the 6 Minute Walk Test performed according to the American Thoracic Guidelines.'}, {'measure': 'Maximal isometric strength', 'timeFrame': '1 and 3 months', 'description': 'Isometrical maximal strength of the brachial biceps and quadriceps muscle of both dominant and non-dominant limbs. Maximal isometric strength will be assessed using a hand-held dynamometer (Lafayette Instrument, Model 01165) and will be presented in kilograms'}, {'measure': 'Sit-to-stand', 'timeFrame': '1 and 3 months', 'description': 'Number of times the patient can stand up from a chair and sit back in 30 seconds'}, {'measure': 'Forced Expiratory Volume 1st second (FEV1)', 'timeFrame': '1 and 3 months', 'description': 'Changes in Forced Expiratory Volume in the 1st second assessed during a forced spirometry test performed according to the international guidelines.'}, {'measure': 'Incremental Symptom-Limited Test', 'timeFrame': '1 and 3 months', 'description': 'Incremental symptom-limited test performed on a cycle-ergometry with a 5-10W increase per minute up to maximal tolerance. Patient was monitorised during the test for both heart rate and oxygen saturation.'}, {'measure': 'Maximal inspiratory and expiratory pressures', 'timeFrame': '1 and 3 months', 'description': 'Maximal inspiratory and expiratory pressures performed with the respiratory muscles'}, {'measure': 'Forced Expiratory Capacity (FVC)', 'timeFrame': '1 and 3 months', 'description': 'Changes in forced expiratory capacity assessed during a forced spirometry test performed according to the international guidelines.'}, {'measure': 'Peak Expiratory Flow (PEF)', 'timeFrame': '1 and 3 months', 'description': 'Changes in peak expiratory flow assessed during a forced spirometry test performed according to the international guidelines.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise Therapy', 'Physical Therapy Modalities', 'Functional Capacity'], 'conditions': ['Lung Transplantation']}, 'descriptionModule': {'briefSummary': 'Lung Transplantation is usually the last option for patients with chronic respiratory conditions in the late stages of the disease. Pulmonary rehabilitation and, particularly, endurance training, is a cornerstone in the management of these patients both during the pre-operative as well as the post-operative period as it improves cardiopulmonary fitness, muscle mass, muscle strength, health-related quality of life and potentially, survival. However, very few studies have been published addressing which modality of training, intensity, frequency or duration of training provides the best possible results in these patients. Therefore, the objective of this study was to compare two training modalities (treadmill walking versus cycle-ergometry) on functional capacity, muscle strength and lung function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing lung transplantation at the Thoracic Surgery Unit of the Hospital Clínico Universitario de A Coruña.\n* Adults \\> 18 years.\n* Ability to attend post-surgery exercise training for a minimum period of one month.\n* Sign informed consent.\n\nExclusion Criteria:\n\n* Torpid post-operative recovery with a prolonged stay at the Post-Anaesthesia Care Unit \\> 12 days.\n* Diagnosed with intensive care unit acquired muscle weakness.'}, 'identificationModule': {'nctId': 'NCT04244305', 'briefTitle': 'Endurance Training in Patients Undergoing Lung Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital A Coruña'}, 'officialTitle': 'Endurance Training in Patients Undergoing Lung Transplantation: Differences Between Treadmill and Cycle Ergometry Training', 'orgStudyIdInfo': {'id': 'EGM-TXP-2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treadmill Training', 'description': "Participants in the treadmill training group will perform endurance training during the post-operative period using a treadmill (Salter Housewares, UK) for a minimum of 20 sessions. Intensity of training will be set according to 80% of the mean speed achieved during the 6MWT for a targeted time of 30 minutes. Intensity and duration will be adapted to the participant's physical condition, especially during the first week.\n\nAfter the endurance training, participants will perform resistance training for 20 - 30 minutes for conditioning of the main muscles in the upper and lower limbs using elastic bands, dumbbells and body-weight exercises. Intensity will progressively increase up to 70% of the maximum isometric strength measured with a hand-held dynamometer. Volume of training will also increase from 1 to 3 sets of 12 repetitions each. When needed patients will also be taught breathing exercises and airway clearance techniques.", 'interventionNames': ['Other: Exercise Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cyclo-ergometry Training', 'description': "Participants in this group will perfom endurance training during the post-operative period using a cycle ergometer (Monark 828e, Monark AB, Sweeden) for a minimum of 20 sessions. Intensity of training will be set according to the results of a symptom-limited incremental cycle-ergometry test performed on the first day to achieve 80% of the maximal workload obtained for a targeted time of 30 minutes. Intensity and duration will be adapted to the participant's physical condition, especially during the first week. Participants in this group will also perfom resistance training and breathing exercises as in the treadmill training group.", 'interventionNames': ['Other: Exercise Therapy']}], 'interventions': [{'name': 'Exercise Therapy', 'type': 'OTHER', 'description': 'Endurance training in the form of treadmill/cycle-ergometry', 'armGroupLabels': ['Cyclo-ergometry Training', 'Treadmill Training']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital A Coruña', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Esther Gimenez Moolhuyzen', 'investigatorAffiliation': 'University Hospital A Coruña'}}}}