Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:14 AM
Study NCT ID:
NCT04001920
Status:
COMPLETED
Last Update Posted:
2019-06-28
First Post:
2019-06-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of a Multiple Component Training Program on Muscles in Adults With Myotonic Dystrophy Type 1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009223', 'term': 'Myotonic Dystrophy'}], 'ancestors': [{'id': 'D009136', 'term': 'Muscular Dystrophies'}, {'id': 'D020966', 'term': 'Muscular Disorders, Atrophic'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020967', 'term': 'Myotonic Disorders'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2013-12-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-26', 'studyFirstSubmitDate': '2019-06-21', 'studyFirstSubmitQcDate': '2019-06-26', 'lastUpdatePostDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-12-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in maximal muscle strength in the knee extensors measured by quantified muscle testing', 'timeFrame': 'Before and after the 12-week training program', 'description': 'Changes in knee extensor maximal muscle strength evaluated by quantified muscle testing with a handheld dynamometer.'}], 'secondaryOutcomes': [{'measure': 'Change in 6 minute walking test disance', 'timeFrame': 'Before and after the 12-week training program', 'description': 'Walking endurance change measured by the 6 minute walking test distance.'}, {'measure': 'Changes in functional capacity measured by the UQAM-YMCA test', 'timeFrame': 'Before and after the 12-week training program', 'description': 'Functional capacity evaluated by 18 functional tests'}, {'measure': 'Changes in sprint capacity measured by the Running-base anaerobic sprint test', 'timeFrame': 'Before and after the 12-week training program', 'description': 'Sprint capacity changes measured by the running-base anaerobic sprint test'}, {'measure': 'Changes in fatigue measured by the Fatigue severity scale', 'timeFrame': 'Before and after the 12-week training program', 'description': 'Fatigue questionnaire: 9-item questionnaire rated on a scale from 1 to 7 for each item. A score a higher score means more fatigue.'}, {'measure': 'Changes in daytime sleepiness measured by the Daytime sleepiness scale (Epworth Sleepiness Scale)', 'timeFrame': 'Before and after the 12-week training program', 'description': '8-item questionnaire, rated on a scale from 0 to 3 for each item, the higher the score, the more the patient has daytime sleepiness.'}, {'measure': 'Changes in stumbles and falls measured by the Falls efficacy scale', 'timeFrame': 'Before and after the 12-week training program', 'description': '10-item questionnaire about stumbles and falls. All items are rated on a 10-point scale. A higher score means a higher fear of falling. A score over 70 means a significant fear of falling.'}, {'measure': 'Changes in quality of life measured by the 36-Item Short Form Survey (SF-36)', 'timeFrame': 'Before and after the 12-week training program', 'description': '36-item quality of life questionnaire. The final score is calculated on a total of 100 where the lower the score, the more disability. A score of 100 means no disability.'}, {'measure': 'Changes in life habits measured by questionnaire', 'timeFrame': 'Before and after the 12-week training program', 'description': 'Life habits questionnaire Assessment of life habits is a 77-item questionnaire with a scale from 0 to 9 for each item. A higher score means no disability and a low score means more disability.'}, {'measure': 'Changes in muscle biopsy-muscle fiber size', 'timeFrame': 'Before and after the 12-week training program for volunteers', 'description': 'To assess changes in muscle fiber size'}, {'measure': 'Changes in muscle biopsy-muscle fiber typing', 'timeFrame': 'Before and after the 12-week training program for volunteers', 'description': 'To assess changes in muscle fiber typing'}, {'measure': 'Changes in muscle biopsy-proportion of centrally nuclated fibers', 'timeFrame': 'Before and after the 12-week training program for volunteers', 'description': 'To assess changes in muscle centrally nucleated fibers proportion'}, {'measure': 'Changes in muscle biopsy-leucocyte infiltration', 'timeFrame': 'Before and after the 12-week training program for volunteers', 'description': 'To assess changes in muscle fiber leucocyte infiltration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myotonic Dystrophy 1']}, 'referencesModule': {'references': [{'pmid': '31429798', 'type': 'DERIVED', 'citation': 'Roussel MP, Morin M, Girardin M, Fortin AM, Leone M, Mathieu J, Gagnon C, Duchesne E. Training program-induced skeletal muscle adaptations in two men with myotonic dystrophy type 1. BMC Res Notes. 2019 Aug 20;12(1):526. doi: 10.1186/s13104-019-4554-z.'}]}, 'descriptionModule': {'briefSummary': 'A strength and endurance training program was conducted in adults with myotonic dystrophy type 1 (DM1). Participants underwent a 12-week/18-session supervised training program consisted of 6 exercises: elbow flexion/extension, shoulder horizontal adduction, leg press, and knee flexion/extension. To offer a complete training program aimed at improving function it was divided: the first 6 weeks were dedicated to strength-training, whereas the following weeks focused on endurance-training. To evaluate the effects of the training program, participants completed maximal strength, endurance and functional evaluations. Volunteers could also add a muscle biopsy at the beginning and the end of the program to evaluate physiological parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults with DM1\n* Walk without technical aid\n* Muscle impairment rating scale (MIRS) of 3 or 4\n\nExclusion Criteria:\n\n* Severe musculoskeletal disorders\n* Any medical contraindication to physical exercise\n* Any medical contraindication to muscle biopsies for the biopsy volunteers'}, 'identificationModule': {'nctId': 'NCT04001920', 'briefTitle': 'Effects of a Multiple Component Training Program on Muscles in Adults With Myotonic Dystrophy Type 1', 'organization': {'class': 'OTHER', 'fullName': 'Université de Sherbrooke'}, 'officialTitle': 'Effects of a Multiple Component Training Program on Muscles, Maximal Muscle Strength, Endurance and Functional Performance in Adults With Myotonic Dystrophy Type 1: A Pilot Study', 'orgStudyIdInfo': {'id': '2013-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Training program', 'description': '12-week strength and endurance training program', 'interventionNames': ['Other: Training program']}], 'interventions': [{'name': 'Training program', 'type': 'OTHER', 'description': '12-week, 18-session training program. To offer a complete training program aimed at improving function it was divided : the first 6 weeks were dedicated to strength-training (2 sets of 6 repetitions at 80% of 1-RM), whereas the following weeks focused on endurance-training (1 set of 25 repetitions at 40% of 1-RM).', 'armGroupLabels': ['Training program']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G7X 7X2', 'city': 'Saguenay', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Groupe de recherche interdisciplinaire sur les maladies neuromusculaires', 'geoPoint': {'lat': 48.41675, 'lon': -71.06573}}], 'overallOfficials': [{'name': 'Cynthia Gagnon, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Sherbrooke'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cynthia Gagnon', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondation du Grand défi Pierre Lavoie', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Sponsor-Investigator', 'investigatorFullName': 'Cynthia Gagnon', 'investigatorAffiliation': 'Université de Sherbrooke'}}}}