Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-02-23 @ 2:21 AM
Study NCT ID:
NCT02158156
Status:
UNKNOWN
Last Update Posted:
2014-06-06
First Post:
2014-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Aerobic Training in Patients With Oculopharyngeal Muscular Dystrophy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D039141', 'term': 'Muscular Dystrophy, Oculopharyngeal'}], 'ancestors': [{'id': 'D009136', 'term': 'Muscular Dystrophies'}, {'id': 'D020966', 'term': 'Muscular Disorders, Atrophic'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, '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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2015-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-06-05', 'studyFirstSubmitDate': '2014-06-04', 'studyFirstSubmitQcDate': '2014-06-05', 'lastUpdatePostDateStruct': {'date': '2014-06-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy based on VO2max', 'timeFrame': '10 weeks', 'description': 'Difference in VO2max measured before and after intervention'}], 'secondaryOutcomes': [{'measure': 'SF-36 Questionaire', 'timeFrame': '10 weeks', 'description': 'Changes in self-rated health from baseline to end of intervention'}, {'measure': '6 minute walk test', 'timeFrame': '10 weeks', 'description': 'Changes in walking distance from baseline to end of intervention'}, {'measure': 'Intensity in maximal load (Watt)', 'timeFrame': '10 weeks', 'description': 'Changes in maximal load (watt) in the VO2max-test from baseline to end of intervention.'}, {'measure': 'Level of plasma creatine kinase', 'timeFrame': '10 weeks', 'description': 'Marker for exercise-induced muscle damage. Taken week 0,3 and 10.'}, {'measure': 'Level of plasma myoglobin', 'timeFrame': '10 weeks', 'description': 'Marker for excercise-induced muscle damage, taken week 0, 3 and 10.'}, {'measure': '6 minute walk test', 'timeFrame': '10 weeks', 'description': 'Changes in walking distance in the test from baseline to end of intervention.'}, {'measure': 'A five-time-repetition-sit-to-stand-test', 'timeFrame': '10 weeks', 'description': 'Changes in time of five repetitions from baseline to end of intervention'}, {'measure': 'A 14-step-stair-test', 'timeFrame': '10 weeks', 'description': 'Changes in time completing the test from baseline to end of intervention'}, {'measure': 'Dynamometry', 'timeFrame': '10 weeks', 'description': 'Changes in external force production from baseline to end of intervention. Dynamometry are measured on hip flexion, dorsal foot flexion, plantar foot flexion, knee flexion, knee extension, and elbow flexion.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Oculopharyngeal Muscular Dystrophy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.neuromuscular.dk', 'label': 'Website of the Neuromuscular Research Unit, Rigshospitalet, Copenhagen, Denmark'}]}, 'descriptionModule': {'briefSummary': 'The investigators want to investigate if patients with Oculopharyngeal Muscular Dystrophy can improve fitness by home-training on a cycle ergometer 30 minute, 3 times a week for 10 weeks.\n\nParticipants will be evaluated on maximal oxygen consumption and maximal workload measured by an incremental test at baseline and at the end of the exercise period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Danish patients with Oculopharyngeal muscular dystrophy\n\nExclusion Criteria:\n\n* Patients who are too week to train on an cycle-ergometer for 10 weeks\n* Patients with other health issues wich confound the interpretation of the efficacy.'}, 'identificationModule': {'nctId': 'NCT02158156', 'briefTitle': 'Effect of Aerobic Training in Patients With Oculopharyngeal Muscular Dystrophy', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Effect of Aerobic Training in Patients With Oculopharyngeal Muscular Dystrophy', 'orgStudyIdInfo': {'id': 'H2-2013-066(A)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Excercise', 'description': '10 weeks of home training on a cycle-ergometer. Exercise 30 minutes every other day or at least three times a week.', 'interventionNames': ['Behavioral: Exercise']}], 'interventions': [{'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': 'Ten weeks of home-training on a cycle ergometer 3 times a week for 30 minutes.', 'armGroupLabels': ['Excercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Vissing', 'role': 'CONTACT', 'phone': '+4535451842'}, {'name': 'Karen BH Pedersen, Med. student, Bsc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Neuromuscular Research Unit', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Karen BH Pedersen, Bsc.med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Neuromuscular Research Unit, Rigshospitalet, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Bsc Medicine', 'investigatorFullName': 'Karen Brorup Heje Pedersen', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}