Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2026-01-11 @ 9:36 PM
Study NCT ID:
NCT02926105
Status:
UNKNOWN
Last Update Posted:
2016-11-11
First Post:
2016-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Home-based Exercise Programmes for Falls Prevention and Quality of Life in Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 405}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-11-10', 'studyFirstSubmitDate': '2016-10-04', 'studyFirstSubmitQcDate': '2016-10-05', 'lastUpdatePostDateStruct': {'date': '2016-11-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of falls', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'Fear of falling', 'timeFrame': 'one year', 'description': 'FES-I'}, {'measure': 'Severity of falls', 'timeFrame': 'one year', 'description': 'Scale of Schwenk 2012'}, {'measure': 'Risk of fall', 'timeFrame': 'one year', 'description': 'Algorithm STEADI'}, {'measure': 'Quality of life', 'timeFrame': 'one year', 'description': 'OPQOL-35'}, {'measure': 'Exercise adherence', 'timeFrame': 'one year', 'description': 'Monthly calender'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Accidental Falls']}, 'referencesModule': {'references': [{'pmid': '38570773', 'type': 'DERIVED', 'citation': 'Hager AM, Mathieu N, Carrard S, Bridel A, Wapp C, Hilfiker R. Partially supervised exercise programmes for fall prevention improve physical performance of older people at risk of falling: a three-armed multi-centre randomised controlled trial. BMC Geriatr. 2024 Apr 3;24(1):311. doi: 10.1186/s12877-024-04927-0.'}, {'pmid': '30642252', 'type': 'DERIVED', 'citation': 'Mittaz Hager AG, Mathieu N, Lenoble-Hoskovec C, Swanenburg J, de Bie R, Hilfiker R. Effects of three home-based exercise programmes regarding falls, quality of life and exercise-adherence in older adults at risk of falling: protocol for a randomized controlled trial. BMC Geriatr. 2019 Jan 14;19(1):13. doi: 10.1186/s12877-018-1021-y.'}], 'seeAlsoLinks': [{'url': 'http://www.swiss-chef-trial.ch', 'label': 'Trial homepage'}]}, 'descriptionModule': {'briefSummary': 'This study compares the effects of three home-based exercise programmes in "at-risk to falling" older adults living in their own home on the incidence of falls (number and severity), risk factors, and quality of life as well as on the adherence to exercise. The subjects will be randomized and allocated in three groups. The group A will receive the "Test-and-Exercise" home-based programme (T\\&E), the group B will receive the "Otago" home-based exercise programme and the group C (activ-control group) will receive the "Helsana" booklet', 'detailedDescription': "Home-based exercise programmes appear to reduce rate of falls, number of fallers, risk of falling and risk of death and to improve balance, leg strength, function, physical activity and balance confidence in older adults living in the community.\n\nThe Test-and-Exercise home-based programme (T\\&E) contains 50 tests and 50 exercises to improve balance, strength and ability in older adults. It is especially built for older adults and is based on the concept of self-efficacy and empowerment. The originality of this programme is the evaluation of the difficulty perceived of the balance-exercises. It is delivered on a booklet which investigators had good experience with in our pilot study, with pictures and descriptions of each test and each exercise. Investigators also developed a mobile application. This application will be transmitted on a tablet-computer. In addition, the participants will receive cards with pictures of the exercises, to put into a plastic sheet to have an overview of their own exercise programme. This programme will be implemented from especially trained physiotherapists.\n\nThe Otago home-based exercise programme was developed in New-Zeeland in the 2000's to prevent falls in older adults. It proposes 22 exercises and walk training. The physiotherapists give an exercise prescription at each home visit. It shows good results for decrease falls in older adults, but the exercise adherence decrease also with the time.\n\nThe Otago home-based exercise programme was developed in New-Zeeland in the 2000's to prevent falls in older adults. It proposes 22 exercises and walk training. The physiotherapists give an exercise prescription at each home visit. It shows good results for decrease falls in older adults, but the exercise adherence decrease also with the time."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 65 years old and older,\n* Living in their own home,\n* Having a history of fall in the previous 12 months or perceiving fear of falling (≥ 20 points on FES-I,\n* Being able to walk without auxiliary tools in their home.\n* Signed Informed Consent\n\nExclusion Criteria:\n\n* Having severe vision impairment that do not permit the reading of the exercise-programme booklet and that do not permit the completing of the monthly diaries,\n* Receiving physiotherapeutic treatment with balance learning,\n* Having cognitive impairment (\\<25 points on the Mini-Mental State Examination (MMSE) of Folstein'}, 'identificationModule': {'nctId': 'NCT02926105', 'acronym': 'SwissCHEF', 'briefTitle': 'Comparison of Home-based Exercise Programmes for Falls Prevention and Quality of Life in Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'HES-SO Valais-Wallis'}, 'officialTitle': 'Comparison of the Effects of Three Home-based Exercise Programmes Regarding Falls, Quality of Life and Exercise-adherence in Older Adults at Risk of Falling: Protocol for a Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'CER-00931'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'T&E Home-based exercise programme', 'description': 'Individually tailored home-based test and exercise programme', 'interventionNames': ['Behavioral: T&E Home-based exercise programme']}, {'type': 'EXPERIMENTAL', 'label': 'Otago', 'description': 'Individually tailored exercise programme', 'interventionNames': ['Behavioral: Otago']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Helsana booklet', 'description': 'Helsana recommendations and exercises', 'interventionNames': ['Behavioral: Helsana booklet']}], 'interventions': [{'name': 'T&E Home-based exercise programme', 'type': 'BEHAVIORAL', 'otherNames': ['T&E'], 'description': '"T\\&E" exercises programme consists of home-based individually tailored balance and functional strength tests and exercises performed 3x a week over 12 months, accompanied by eight in-home visits of physiotherapists during the first six months.', 'armGroupLabels': ['T&E Home-based exercise programme']}, {'name': 'Otago', 'type': 'BEHAVIORAL', 'description': 'Otago exercises programme consists of home-based individually tailored balance, strength and walking exercises performed 3x a week over 12 months, accompanied by eight in-home visits of physiotherapists during the first six months.', 'armGroupLabels': ['Otago']}, {'name': 'Helsana booklet', 'type': 'BEHAVIORAL', 'otherNames': ['Helsana'], 'description': 'Helsana programme consists of a booklet with recommendations and 10 exercises performed 3x a week over 12 months.', 'armGroupLabels': ['Helsana booklet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1066', 'city': 'Épalinges', 'state': 'Canton of Vaud', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Constanze Lenoble-Hoskovec, BS', 'role': 'CONTACT', 'email': 'constanze.hoskovec@chuv.ch', 'phone': '+41 79 556 62 46'}, {'name': 'Isabelle Le Franc-Guégo, BS', 'role': 'CONTACT', 'email': 'isbelle.guego@chuv.ch', 'phone': '+41 79 556 12 86'}, {'name': 'Constanze Lenoble-Hoskovec, BS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CUTR Sylvana', 'geoPoint': {'lat': 46.54896, 'lon': 6.66831}}, {'zip': '8032', 'city': 'Zurich', 'state': 'Canton of Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Jaap Swanenburg, PhD', 'role': 'CONTACT', 'email': 'cheftrialzurich@bluewin.ch', 'phone': '+41 44 261 53 61'}], 'facility': 'Physiotherapie Nevzati', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': '3954', 'city': 'Leukerbad', 'state': 'Valais', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Nicolas Mathieu, MS', 'role': 'CONTACT', 'email': 'nicolas.mathieu@hevs.ch', 'phone': '+41 79 300 44 31'}, {'name': 'Annick Bonvin', 'role': 'CONTACT'}, {'name': 'Martin Plaschy, MA', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nicole Gay-Balmaz, BS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Anne-Gabrielle Mittaz Hager, MS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'HES-SO Valais-Wallis', 'geoPoint': {'lat': 46.37943, 'lon': 7.62687}}], 'centralContacts': [{'name': 'Anne-Gabrielle Mittaz Hager, MS', 'role': 'CONTACT', 'email': 'gaby.mittaz@hevs.ch', 'phone': '+41 79 609 90 63'}, {'name': 'Roger Hilfiker, MS', 'role': 'CONTACT', 'email': 'roger.hilfiker@hevs.ch', 'phone': '+41 79 688 34 90'}], 'overallOfficials': [{'name': 'Anne-Gabrielle Mittaz Hager, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HES-SO Valais-Wallis'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HES-SO Valais-Wallis', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondation Leenaards, Switzerland', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}