Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2026-02-21 @ 5:57 AM
Study NCT ID:
NCT02161835
Status:
COMPLETED
Last Update Posted:
2015-05-14
First Post:
2014-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relations Between Myotonia and Fitness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009224', 'term': 'Myotonia Congenita'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D020967', 'term': 'Myotonic Disorders'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-13', 'studyFirstSubmitDate': '2014-06-06', 'studyFirstSubmitQcDate': '2014-06-10', 'lastUpdatePostDateStruct': {'date': '2015-05-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in myotonia', 'timeFrame': 'Week 0 and week 10', 'description': 'Changes in myotonia is assessed before and after 10 weeks of exercise training. Myotonia is measured as self-assessment of myotonia using the Myotonia Behavior Scale every day in a week before training start and every day in a week before training finish. Furthermore, myotonia is measured as changes in time climbing a 14 steps stair before and after the 10 weeks training period.'}], 'secondaryOutcomes': [{'measure': 'Changes in fitness', 'timeFrame': 'baseline and after week 10', 'description': 'An incremental test is performed at baseline and in the end of 10 weeks training. The primary outcome is change between the two tests in maximal oxygen consumption and work load.'}, {'measure': 'Changes in creatine Kinase', 'timeFrame': 'baseline, week 2, week 4, week 7 and week 10', 'description': 'Creatine Kinase (CK) is measure in plasma to follow muscle injury during the trial.'}, {'measure': 'Changes in other myotonia', 'timeFrame': 'baseline and after week 10', 'description': 'Myotonia assessed by eye-open-close test, hand open-close test, and by up-and-go test. The three performance tests describe objectively the degree of myotonia.\n\nThe outcome measure is changes between before and after training.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Congenital myotonia', 'Myotonia congenita', 'Thomsons disease', 'Becker type', 'Training', 'Exercise'], 'conditions': ['Congenital Myotonia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://neuromuscular.dk', 'label': 'Neuromuscular research unit Copenhagen homepage.'}]}, 'descriptionModule': {'briefSummary': 'Investigators aimed to investigate whether training can increase fitness levels in patients with myotonia, and thereby reduce the symptom of myotonia.', 'detailedDescription': 'Investigators aimed to investigate whether a 10-week bicycle exercise program can increase fitness levels in patients with myotonia, and thereby reduce the symptom of myotonia in everyday life. The effect on myotonia is assessed by a standardized myotonia scale with six statements concerning self-rated myotonia, and a number of performance tests that objectively describes the degree of myotonia.\n\nThe effect of the training program is assessed by an incremental test, measuring maximal oxygen uptake, maximal heart rate and maximal workload. The muscle enzyme creatine kinase (CK) is measured in plasma to follow muscle injury and safety during the training.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with either Myotonia congenita or Paramyotonia congenita.\n* Patients who have symptoms of myotonia while they are walking stairs.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women.\n* Physical or mental condition, which prevent participating in the study protocol or which could influence the results.\n* Participating in other studies, which could influence the results.'}, 'identificationModule': {'nctId': 'NCT02161835', 'briefTitle': 'Relations Between Myotonia and Fitness', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Relations Between Fitness Status and the Severity of Myotonia in Patients With Congenital Myotonia', 'orgStudyIdInfo': {'id': 'H-4-2014-026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Training', 'description': 'Participants exercise 3 times a week, 30 minute, on an ergometer bike.', 'interventionNames': ['Other: Training']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants is tested with the 4 objective myotonia test and measurements of self-assessed myotonia by the Myotonia Behavior Scale is collected.'}], 'interventions': [{'name': 'Training', 'type': 'OTHER', 'description': '30 minutes of home based pulse watch regulated cycle-ergometer exercise, three times a week at 75% of maximal oxygen consumption.', 'armGroupLabels': ['Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Neuromuscular Research Unit, Department of Neurology, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Grete Andersen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Neuromuscular research unit Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Grete Andersen, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Grete Andersen, MD', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}