Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-02-20 @ 6:45 PM
Study NCT ID:
NCT02746835
Status:
COMPLETED
Last Update Posted:
2016-04-21
First Post:
2016-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physical Condition and Self-efficacy in People With Fall Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-19', 'studyFirstSubmitDate': '2016-04-11', 'studyFirstSubmitQcDate': '2016-04-19', 'lastUpdatePostDateStruct': {'date': '2016-04-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Physical Condition related with mobility', 'timeFrame': '6-weeks', 'description': 'mobility (5 meters walking test at comfortable speed - 5mWT) (meters/second)'}, {'measure': 'Physical Condition related with balance', 'timeFrame': '6-weeks', 'description': 'balance (Functional Reach Test - FRT) (cm)'}, {'measure': 'Physical Condition related with endurance', 'timeFrame': '6-weeks', 'description': 'endurance (Sit-to-stand test - STS) (seconds)'}], 'primaryOutcomes': [{'measure': 'Self-efficacy moving indoors', 'timeFrame': '6-weeks', 'description': 'Question 1- Self-efficacy moving indoors; (scoring: 0-not confident - 2-very confident)'}, {'measure': 'Self-efficacy moving outside', 'timeFrame': '6-weeks', 'description': 'Question 2 - Self-efficacy moving outside (scoring: 0-not confident - 2-very confident)'}, {'measure': 'Self-efficacy walking uneven surfaces', 'timeFrame': '6-weeks', 'description': 'Question 3- Self-efficacy walking through uneven surfaces (scoring: 0-not confident - 2-very confident)'}, {'measure': 'Self-efficacy in physical activities', 'timeFrame': '6-weeks', 'description': 'Question 4 - Self-efficacy participating in physical activities (scoring: 0-not confident - 2-very confident)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['physical condition', 'self-efficacy', 'fall risk', 'exercise program'], 'conditions': ['Fall Risk']}, 'descriptionModule': {'briefSummary': 'Middle-aged or older people with fall risk were assessed and invited to a multidisciplinary falls prevention program. This program consisted on an adapted exercise program.\n\nTwo sessions per week were performed, during 6 weeks supervised by a physiotherapist.\n\nAt the end of this program, measures of physical condition and of self-efficacy were repeated to determine its related-effect.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fall Risk (Morse scale)\n\nExclusion Criteria:\n\n* Had no capacity to walk independently'}, 'identificationModule': {'nctId': 'NCT02746835', 'acronym': 'Fall Risk', 'briefTitle': 'Physical Condition and Self-efficacy in People With Fall Risk', 'organization': {'class': 'OTHER', 'fullName': 'Aveiro University'}, 'officialTitle': 'Physical Condition and Self-efficacy in People With Fall Risk - a Preliminary Study', 'orgStudyIdInfo': {'id': 'Falls Prevention Program'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise Protocol', 'description': 'Set of exercises for balance, endurance, muscle strength and flexibility', 'interventionNames': ['Other: Exercise program for fall prevention']}], 'interventions': [{'name': 'Exercise program for fall prevention', 'type': 'OTHER', 'description': 'Set of exercises to improve the following parameters:\n\nbalance, endurance, muscle strength, flexibility.', 'armGroupLabels': ['Exercise Protocol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3780-351', 'city': 'Anadia', 'state': 'Aveiro District', 'country': 'Portugal', 'facility': 'Marlene Cristina Neves Rosa', 'geoPoint': {'lat': 40.43841, 'lon': -8.43352}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aveiro University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centro de Saúde de Anadia', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Marlene Rosa', 'investigatorAffiliation': 'Aveiro University'}}}}