Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-01-05 @ 2:56 PM
Study NCT ID:
NCT02920151
Status:
COMPLETED
Last Update Posted:
2016-09-30
First Post:
2016-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Balance Exercises Circuit in Patients With Hip or Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-28', 'studyFirstSubmitDate': '2016-09-12', 'studyFirstSubmitQcDate': '2016-09-28', 'lastUpdatePostDateStruct': {'date': '2016-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'static balance', 'timeFrame': 'three months', 'description': 'static balance assessed by force plate'}, {'measure': 'Timed Up and Go', 'timeFrame': 'three months', 'description': 'functional performance and functional balance'}], 'primaryOutcomes': [{'measure': 'Berg Balance Scale', 'timeFrame': 'three months', 'description': 'evaluates functional balance'}], 'secondaryOutcomes': [{'measure': 'QuickScreen scale', 'timeFrame': 'three months', 'description': 'fall risk assessement'}, {'measure': 'Falls Efficacy Scale', 'timeFrame': 'three months', 'description': 'self-efficacy or confidence in performing activities without falling'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hip Replacement', 'Knee Replacement', 'Postural Balance']}, 'descriptionModule': {'briefSummary': 'This study evaluates the effect of balance circuit in patients with more than one year of postoperative total hip or knee arthroplasty. Patients were randomized between intervention group (IG) (balance exercise circuit ) and control group (CG) (usual routine). The evaluations were conducted by blind examiners.', 'detailedDescription': 'Balance Exercise Circuit (BEC) program, includes exercise that specifically challenge sensory inputs from mechanoreceptors as well as from the visual and vestibular systems. It is composed of 13 stations, involving static and dynamic balance exercises, including tandem walking, forward-backward stepping, wide-stance gait, functional reach, heel lift, toe press, balance on unstable surfaces, and standing on one leg. The BEC lasts 50 min, two times per week for a total of 12 weeks. Progression of exercises occurred every 3 weeks and was closely supervised to ensure safety. Each BEC session comprised of warm-up and stretching (10 min), exercise circuit (30 min), and cool-down (10 min).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* more than one year of postoperative total hip or knee arthroplasty\n\nExclusion Criteria:\n\n* total hip AND knee arthroplasty\n* other surgeries of the lower limbs and spine\n* autoimmune disease\n* contraindication for physical exercise'}, 'identificationModule': {'nctId': 'NCT02920151', 'acronym': 'BECA', 'briefTitle': 'Effects of Balance Exercises Circuit in Patients With Hip or Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Grupo de Estudos e Pesquisas Sobre Atividade Física Para Idosos'}, 'officialTitle': 'Effects of Balance Exercises Circuit in Patients With Total Hip or Knee Arthroplasty (BECA): A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Gepafi'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BALANCE EXERCISES CIRCUIT', 'description': 'balance exercises circuit for three months, twice weekly, 50 minutes per day.', 'interventionNames': ['Other: balance exercises circuit']}, {'type': 'NO_INTERVENTION', 'label': 'CONTROL GROUP', 'description': 'usual routine'}], 'interventions': [{'name': 'balance exercises circuit', 'type': 'OTHER', 'otherNames': ['exercises'], 'description': 'Thirteen workstations were organized in a circuit format on involved multidirectional gait in different bases of support, unstable surfaces, functional reach, exercise with balls, and single-leg stance', 'armGroupLabels': ['BALANCE EXERCISES CIRCUIT']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Marisete P Safons', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Grupo de Estudos e Pesquisas Sobre Atividade Física Para Idosos'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Grupo de Estudos e Pesquisas Sobre Atividade Física Para Idosos', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Marisete Peralta Safons', 'investigatorAffiliation': 'Grupo de Estudos e Pesquisas Sobre Atividade Física Para Idosos'}}}}