Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2026-02-24 @ 3:52 AM
Study NCT ID:
NCT03320005
Status:
UNKNOWN
Last Update Posted:
2017-10-24
First Post:
2017-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EFFECTS OF RESISTANCE TRAINING IN ELDERLY
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-19', 'studyFirstSubmitDate': '2017-08-07', 'studyFirstSubmitQcDate': '2017-10-19', 'lastUpdatePostDateStruct': {'date': '2017-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical performance', 'timeFrame': 'Change from Baseline at 24 weeks', 'description': 'distance traveled on ISWT'}], 'secondaryOutcomes': [{'measure': 'quality of life', 'timeFrame': 'Change from Baseline at 24 weeks', 'description': 'quality of life (WHOQOL-old)'}, {'measure': 'respiratory muscle strength', 'timeFrame': 'Change from Baseline at 24 weeks', 'description': 'respiratory pressures'}, {'measure': 'Hand grip', 'timeFrame': 'Change from Baseline at 24 weeks', 'description': 'Hand grip test'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['respiratory performance', 'quality of life', 'physical performance'], 'conditions': ['Aging Disorder']}, 'descriptionModule': {'briefSummary': 'This comes from a non-randomized clinical trial, which aims to check on elderly women the effects of a program of resistance training (TR) in physical performance, in respiratory functional capacity, on health and quality of life.', 'detailedDescription': 'Will be measured the strength of the respiratory muscles (Mip and Mep), peak expiratory flow (Peak-Flow), thoracic movements and abdominal movements, distance traveled in Incremental Shuttle Walk Test, grip strength manual, pulmonary leukocytes, biochemical parameters and indicators of quality of life and physical activity through the WHOQOL-old and IPAQ-short. The data will be tested against the distribution of the Gauss curve, by the shapiro-wilk test and, if they have a normal distribution (parametric) are expressed as mean and standard deviation, if not submit normal (non parametric) distribution will be expressed as median or range interquartÃlico. The first chance to compare the evolution of the group studied, will be applied to two-way ANOVA. If the distribution is abnormal, it will apply Mann-Whitney test. The multiple regression test will be used to compare the Mip and Mep with variables with the Peak-Flow, Thoracoabdominal mobility, distance traveled, immune competence, physical fitness and quality of life in the groups studied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 60 year old or more\n* Do not have cardiac or respiratory diseases\n* neurological, Musculoskeletal and other diseases preventing the practice of exercises\n* not being a smoker; agree to participate in the study and signed an informed consent (IC); in the last six months preceding the evaluation did not have participated in physical activity program with the aim of improving physical performance.\n\nExclusion Criteria:\n\n* Difficult to complete the tasks\n* Acute diseases\n* Refuse to continue the program'}, 'identificationModule': {'nctId': 'NCT03320005', 'briefTitle': 'EFFECTS OF RESISTANCE TRAINING IN ELDERLY', 'organization': {'class': 'OTHER', 'fullName': 'University of Nove de Julho'}, 'officialTitle': 'EFFECTS OF RESISTANCE TRAINING ON THE PHYSICAL AND FUNCTIONAL RESPIRATORY PERFORMANCE OF ELDERLY', 'orgStudyIdInfo': {'id': 'Resist protocol'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ResistanceTraining Group', 'description': 'The RT program has the following features: 05 classes performing two weekly sessions; day shift; sessions with maximum duration of 1 (one) hour; 02 series; 08 to 12 repetitions; interval between sets of 01 to 02 minutes; exercises: bench press, seated leg press 45°, pull forward, Earth, rowing standing calf standing, power lifting, abdominal and development.', 'interventionNames': ['Other: Resistance training group']}, {'type': 'NO_INTERVENTION', 'label': 'Non training group', 'description': 'sedentary elderly'}], 'interventions': [{'name': 'Resistance training group', 'type': 'OTHER', 'description': 'Resistive exercises for legs and arms', 'armGroupLabels': ['ResistanceTraining Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Dirceu Costa, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Nove de Julho University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daysi Tobelem', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Daysi Tobelem', 'investigatorAffiliation': 'University of Nove de Julho'}}}}