Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-03-03 @ 4:12 PM
Study NCT ID:
NCT03092167
Status:
COMPLETED
Last Update Posted:
2021-04-30
First Post:
2017-03-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physical Training in Patients With Idiopathic Inflammatory Myopathies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009220', 'term': 'Myositis'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, '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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open label'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '15 idiopathic inflammatory myopathies submmited to physical exercises 15 idiopathic inflammatory myopathies not submmited to physcial exercises 10 healthy individuals'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-29', 'studyFirstSubmitDate': '2017-03-09', 'studyFirstSubmitQcDate': '2017-03-21', 'lastUpdatePostDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiopulmonary test', 'timeFrame': '12 weeks', 'description': 'Patients will undertake a maximal graded exercise test on a treadmill, with increments in velocity and grade at every minute until volitional exhaustion. VO2peak will be considered as the average of the final 30 s of the test. Ventilatory threshold (VAT) will be determined when ventilatory equivalent for VO2 (VE/VO2) increased without a concomitant increase in ventilatory equivalent for carbon dioxide (VE/VCO2). Respiratory compensation point (RCP) will be determined when VE/VO2 and VE/VCO2 increased simultaneously.'}], 'secondaryOutcomes': [{'measure': 'Serum cytokines', 'timeFrame': '12 weeks', 'description': "Blood samples will be centrifuged at 3000 rpm for 15 min at 4°C, and the serum aliquot will be stored at -80°C for subsequent analyses. Cytokines (i.e., IL-6, TNF alpha, IFN gamma) will be measured using a multiplex human panel (Milliplex Map, Millipore, Billerica, MA, USA). Data analysis will be performed through Luminex xMAP Technology, according to the manufacturer's instructions."}, {'measure': 'Strength muscle tests', 'timeFrame': '12 weeks', 'description': 'The dynamic 1-RM for the leg-press and the bench-press exercises, arm curl (with the dominant arm).'}, {'measure': 'Muscle biopsies', 'timeFrame': '12 weeks', 'description': 'After local anesthesia, a cutaneous incision will be made in lateral thigh face. The biopsy will be done using the Bergstrom needle. Histological (hematoxylin and eosin)/immunohistochemical (CD4, CD8, CD68, CD20, C5b-9, MHCI, MHCII, CD31) analysis will be performed in muscle samples (at baseline and after 12 weeks) in all patients (present study)'}, {'measure': 'Functional muscle tests', 'timeFrame': '12 weeks', 'description': 'Isometric strength (assessed by handgrip, with the dominant arm) will be assessed at baseline and after the intervention. Muscle function will be evaluated through the TUG and the TST tests.'}, {'measure': 'Myositis Disease Activity Assessment Tool', 'timeFrame': '12 weeks', 'description': "This partially validated tool measures the degree of disease activity of extra-muscular organ systems and muscle. This is a combined tool that includes the Myositis Disease Activity Assessment Visual Analogue Scales (MYOACT), which is a series of physician's assessments of disease activity, and the Myositis Intention to Treat Activity Index (MITAX)."}, {'measure': 'Muscle enzymes', 'timeFrame': '12 weeks', 'description': 'This partially validated tool measures the serum activities of at least 2 of the 4 muscle-associated enzymes including creatine phosphokinase (CK), the transaminases (ALT, AST), lactate dehydrogenase (LD) and aldolase.'}, {'measure': 'Health Assessment Questionnaire', 'timeFrame': '12 weeks', 'description': 'Especific questionnaire (health assessment questionnaire). Pontuaction 0.00-3.00'}, {'measure': 'Manual Muscle Testing', 'timeFrame': '12 weeks', 'description': 'This partially validated tool assesses muscle strength using manual muscle testing (MMT). A 0 - 10 point scale is proposed for use. An abbreviated group of 8 proximal, distal, and axial muscles performs similarly to a total of 24 muscle groups, and is also proposed for use for research studies.'}, {'measure': 'Patient/Parent Global Activity', 'timeFrame': '12 weeks', 'description': "This partially validated tool measures the global evaluation by the patient, or by the parent if the patient is a minor, of the patient's overall disease activity at the time of assessment using a 10 cm. visual analogue scale."}, {'measure': 'Physician Global Activity', 'timeFrame': '12 weeks', 'description': 'This partially validated tool measures the global evaluation by the treating physician of the overall disease activity of the patient at the time of assessment using a 10 cm. visual analogue scale and a 5 point Likert scale.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Idiopathic Inflammatory Myopathies', 'Physical Activity']}, 'referencesModule': {'references': [{'pmid': '34227790', 'type': 'DERIVED', 'citation': 'Borges IBP, de Oliveira DS, Marie SKN, Lenario AM, Oba-Shinjo SM, Shinjo SK. Exercise Training Attenuates Ubiquitin-Proteasome Pathway and Increases the Genes Related to Autophagy on the Skeletal Muscle of Patients With Inflammatory Myopathies. J Clin Rheumatol. 2021 Sep 1;27(6S):S224-S231. doi: 10.1097/RHU.0000000000001721.'}]}, 'descriptionModule': {'briefSummary': 'Physical training may improve physical capacity and health parameters in various systemic autoimmune diseases, including idiopathic inflammatory myopathies. Therefore, the present study will assess the role of an exercise training program in patients with idiopathic inflammatory myopathies.', 'detailedDescription': 'To assess the impact of 12-weeks of physical training in patients with idiopathic inflammatory myopathies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of DM / PM according to the criteria of Bohan and Peter (1975)\n* Both genders and age ≥ 18 years\n* Use of prednisone ≤ 0.5 mg/kg/day in the last three months. The dose of prednisone will be kept fixed throughout the study\n* Physically inactive\n\nExclusion Criteria:\n\n* Disease relapsing\n* Neoplasia associated-myositis\n* Overlapping myositis\n* Use of lipid-lowering drugs\n* Smoking\n* Diabetes mellitus'}, 'identificationModule': {'nctId': 'NCT03092167', 'briefTitle': 'Physical Training in Patients With Idiopathic Inflammatory Myopathies', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Physical Training in Patients With Idiopathic Inflammatory Myopathies', 'orgStudyIdInfo': {'id': 'MYO-HCFMUSP-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Case', 'description': 'Patients: this group will be submitted to 12-weeks, twice/week, physical exercises.', 'interventionNames': ['Other: Physical exercises']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patients: this group will not be submitted to 12-weeks, twice/week, physical exercises.'}, {'type': 'NO_INTERVENTION', 'label': 'Healthy control', 'description': 'Volunteers: this group will not be submitted to 12-weeks, twice/week, physical exercises.'}], 'interventions': [{'name': 'Physical exercises', 'type': 'OTHER', 'description': 'Physical exercises', 'armGroupLabels': ['Case']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01246903', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Samuel Katsuyuki Shinjo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Samuel K Shinjo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade de Sao Paulo - Rheumatology Division'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Samuel Katsuyuki Shinjo, PhD', 'investigatorAffiliation': 'University of Sao Paulo'}}}}