Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2025-12-29 @ 9:43 AM
Study NCT ID:
NCT03802357
Status:
UNKNOWN
Last Update Posted:
2019-01-16
First Post:
2019-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Different Exercise Training Modalities in Alpha-1 Antitrypsin Deficiency Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D019896', 'term': 'alpha 1-Antitrypsin Deficiency'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D013352', 'term': 'Subcutaneous Emphysema'}, {'id': 'D004646', 'term': 'Emphysema'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized into two Intervention Groups (high vs. moderate Training intensity).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-14', 'studyFirstSubmitDate': '2019-01-10', 'studyFirstSubmitQcDate': '2019-01-10', 'lastUpdatePostDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endurance shuttle walk test (ESWT)', 'timeFrame': 'Change in the duration of the ESWT from day 1 to day 21', 'description': 'The ESWT is performed at 85% of the Peak gate Speed, measured during the Initial incremental shuttle walk test.'}], 'secondaryOutcomes': [{'measure': 'Oxygen saturation', 'timeFrame': 'Change in the oxygen saturation at isotime from day 1 to day 21', 'description': 'Outcome will be assessed at the the time Point of the end of the shortest ESWT ("isotime").'}, {'measure': 'Heart rate', 'timeFrame': 'Change in the heart rate at isotime from day 1 to day 21', 'description': 'Outcome will be assessed at the the time Point of the end of the shortest ESWT ("isotime").'}, {'measure': 'Partial pressure of carbon dioxide (CO2)', 'timeFrame': 'Change in the partial pressure of CO2 at isotime from day 1 to day 21', 'description': 'Parameter will be measured by Sentec (R) device. Outcome will be assessed at the the time Point of the end of the shortest ESWT ("isotime").'}, {'measure': 'Lactate concentration', 'timeFrame': 'Change in lactate concentration at isotime from day 1 to day 21', 'description': 'Outcome will be assessed at the the time Point of the end of the shortest ESWT ("isotime").'}, {'measure': 'Perceived Dyspnea', 'timeFrame': 'Change in perceived dyspnea at isotime from day 1 to day 21', 'description': 'Dyspnea will be rated on a 0 to 10-point BORG scale where lower values represent less dyspnea and vice versa. The total score will be assessed at the the time Point of the end of the shortest ESWT ("isotime").'}, {'measure': 'Strength capacity in knee extension', 'timeFrame': 'Change in strength from day 1 to day 21', 'description': 'Strength will be measured by a Hand Held Dynamometer (Microfet (R)).'}, {'measure': 'Balance performance', 'timeFrame': 'Change in balance performance from day 1 to day 21', 'description': 'absolute path length will be measured on a force plate (Leonardo (R)) during the Tandem stance'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pulmonary rehabilitation', 'Exercise training', 'Alpha-1 Antitrypsin deficiency'], 'conditions': ['Chronic Obstructive Pulmonary Disease', 'Alpha 1-Antitrypsin Deficiency']}, 'descriptionModule': {'briefSummary': 'Pulmonary rehabilitation (PR) including exercise training is highly effective by improving health-related quality of life, exercise capacity and symptoms in patients with chronic obstructive pulmonary disease (COPD). Therefore, PR is a main component in the management of COPD. In a former study patients with Alpha-1 Antitrypsin deficiency (A1ATD)-related COPD (genotype PiZZ) have been found to show smaller improvements in exercise capacity after a 3-week inpatient PR program compared to COPD patients without A1ATD (genotype PiMM)\\[1\\]. These between-group differences were mirrored by missing adaptations of the fatigue-resistant skeletal muscle fibre type I in A1ATD patients. This was in contrast to COPD patients without A1ATD who increased the proportion of this fibre type after PR. Myofibre type I is crucial because it enables patients for physical endurance activities (walking, cycling etc.) during their daily life.\n\nThe aim of this study is to compare the effects of an exercise Training program with high vs. moderate Training intensity in order to find a Training modality which improves Training effects in A1ATD patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COPD patients with A1ATD (genotype PiZZ)\n* COPD patients without A1ATD (genotype PiMM)\n* Global initiative for chronic obstructive lung disease (GOLD) stage III-IV\n* Medical Treatment according to recent A1ATD guidelines\n\nExclusion Criteria:\n\n* General exclusion criteria for physical Training such as acute coronary Syndrome, acute myo- or pericarditis, acute lung embolism, acute heart failure, orthopedic comorbidities which prevent patients from participating in exercise Training program.\n* No written informed consent\n* Non-compliance'}, 'identificationModule': {'nctId': 'NCT03802357', 'briefTitle': 'Effects of Different Exercise Training Modalities in Alpha-1 Antitrypsin Deficiency Patients', 'organization': {'class': 'OTHER', 'fullName': 'Schön Klinik Berchtesgadener Land'}, 'officialTitle': 'Effects of Moderate vs. High Intensity Exercise Training During Pulmonary Rehabilitation in Alpha-1 Antitrypsin Deficiency Patients', 'orgStudyIdInfo': {'id': 'AAT Training'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High training intensity', 'description': 'Exercise Training with high intensities consists of a cycling Interval Training at 100% of the individual Peak work rate, resistance Training for 3 sets à 8 repetitions and squats on a Vibration plate.', 'interventionNames': ['Procedure: Exercise training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'moderate training intensity', 'description': 'Exercise Training with moderate intensities consists of a cycling endurance Training at 60% of the individual Peak work rate, resistance Training for 3 sets à 20 repetitions and squats on the floor.', 'interventionNames': ['Procedure: Exercise training']}], 'interventions': [{'name': 'Exercise training', 'type': 'PROCEDURE', 'description': 'Patients perform an exercise Training program of 3 weeks Duration including endurance Training, resistance Training and squat Training. This program is part of an inpatient pulmonary Rehabilitation.', 'armGroupLabels': ['High training intensity', 'moderate training intensity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '83471', 'city': 'Schönau am Königssee', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Klaus Kenn, Prof. Dr.', 'role': 'CONTACT', 'email': 'kkenn@schoen-klinik.de', 'phone': '0865293', 'phoneExt': '1540'}, {'name': 'Inga Jarosch, Dr.', 'role': 'CONTACT', 'email': 'ijarosch@schoen-klinik.de', 'phone': '0865293', 'phoneExt': '1730'}], 'facility': 'Schoen Klinik Berchtesgadener Land', 'geoPoint': {'lat': 47.60055, 'lon': 12.98704}}], 'centralContacts': [{'name': 'Klaus Kenn, Prof. Dr.', 'role': 'CONTACT', 'email': 'kkenn@schoen-klinik.de', 'phone': '0865293', 'phoneExt': '1540'}, {'name': 'Inga Jarosch, Dr.', 'role': 'CONTACT', 'email': 'ijarosch@schoen-klinik.de', 'phone': '0865293', 'phoneExt': '1730'}], 'overallOfficials': [{'name': 'Klaus Kenn, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Schoen Klinik Berchtesgadener Land'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Schön Klinik Berchtesgadener Land', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head physician', 'investigatorFullName': 'Klaus Kenn', 'investigatorAffiliation': 'Schön Klinik Berchtesgadener Land'}}}}