Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-02-03 @ 9:51 AM
Study NCT ID:
NCT02864056
Status:
COMPLETED
Last Update Posted:
2018-12-17
First Post:
2016-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The TACIT Trial: TAi ChI for People With demenTia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-09-19', 'releaseDate': '2022-11-10'}], 'estimatedResultsFirstSubmitDate': '2022-11-10'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026302', 'term': 'Tai Ji'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 172}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-14', 'studyFirstSubmitDate': '2016-08-05', 'studyFirstSubmitQcDate': '2016-08-08', 'lastUpdatePostDateStruct': {'date': '2018-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Timed Up and Go test', 'timeFrame': '6 months from Baseline'}], 'secondaryOutcomes': [{'measure': 'Berg Balance Scale (BBS)', 'timeFrame': '6 months from Baseline'}, {'measure': 'Postural sway', 'timeFrame': '6 months from Baseline', 'description': 'Performance while standing on the floor and on a foam mat'}, {'measure': 'Iconographical Falls Efficacy Scale (Icon-Fes, short form)', 'timeFrame': '6 months from Baseline', 'description': '10 item scale of fear of falling'}, {'measure': 'Statue task', 'timeFrame': '6 months from Baseline', 'description': 'Visual-spatial cognitive functioning using visual scenes on a small handheld tablet'}, {'measure': 'ICEpop CAPability measure for Older people (ICECAP-O)', 'timeFrame': '6 months from Baseline'}, {'measure': 'Number and rate of falls', 'timeFrame': '6 months from Baseline'}, {'measure': 'Number and rate of fallers', 'timeFrame': '6 months from Baseline'}, {'measure': 'Number and rate of injurious falls', 'timeFrame': '6 months from Baseline'}, {'measure': 'Zarit Burden Interview (short-form)', 'timeFrame': '6 months from Baseline', 'description': '12 item scale assessing burden on carer'}, {'measure': "Mini-Addenbrooke's Cognitive Examination (M-ACE)", 'timeFrame': '6 months from Baseline', 'description': 'Assess global cognitive functioning'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dementia', 'Accidental Falls']}, 'referencesModule': {'references': [{'pmid': '36706322', 'type': 'DERIVED', 'citation': 'Nyman SR, Casey C, Greenwood N. Hypothesis: Dementia Diminishes Interdependence in Health and Quality of Life Among Spousal Partners. Alzheimer Dis Assoc Disord. 2023 Apr-Jun 01;37(2):174-177. doi: 10.1097/WAD.0000000000000539. Epub 2023 Jan 18. No abstract available.'}, {'pmid': '33141417', 'type': 'DERIVED', 'citation': 'Williams J, Nyman S. A secondary analysis of a randomised controlled trial to investigate the effect of Tai Chi on the instrumented timed up and go test in people with mild to moderate dementia. Aging Clin Exp Res. 2021 Aug;33(8):2175-2181. doi: 10.1007/s40520-020-01741-7. Epub 2020 Nov 3.'}, {'pmid': '31819385', 'type': 'DERIVED', 'citation': 'Nyman SR, Ingram W, Sanders J, Thomas PW, Thomas S, Vassallo M, Raftery J, Bibi I, Barrado-Martin Y. Randomised Controlled Trial Of The Effect Of Tai Chi On Postural Balance Of People With Dementia. Clin Interv Aging. 2019 Nov 19;14:2017-2029. doi: 10.2147/CIA.S228931. eCollection 2019.'}, {'pmid': '30390620', 'type': 'DERIVED', 'citation': 'Nyman SR, Hayward C, Ingram W, Thomas P, Thomas S, Vassallo M, Raftery J, Allen H, Barrado-Martin Y. A randomised controlled trial comparing the effectiveness of tai chi alongside usual care with usual care alone on the postural balance of community-dwelling people with dementia: protocol for the TACIT trial (TAi ChI for people with demenTia). BMC Geriatr. 2018 Nov 3;18(1):263. doi: 10.1186/s12877-018-0935-8.'}], 'seeAlsoLinks': [{'url': 'http://www.bournemouth.ac.uk/tai-chi', 'label': 'Trial webpage'}]}, 'descriptionModule': {'briefSummary': "This is a three-centre parallel group randomised controlled trial with an embedded process evaluation and intervention pilot phase (details not provided in this summary). The overall research question is: Can a Tai Chi exercise programme prevent falls among people with dementia (PWD), specifically among older PWD living at home?\n\nPrimary Outcome measure:\n\n• dynamic postural balance (as a surrogate for falls).\n\nSecondary outcome measures:\n\n* to explore the effects of a Tai Chi exercise programme on static and functional postural balance, fear of falling, cognitive functioning, falls, and quality of life. Also to explore the effects of a Tai Chi exercise programme on their informal carer's dynamic and static postural balance, quality of life, and carer burden\n* to determine the acceptability and safety of the Tai Chi intervention\n* to inform the design of a future definitive clinical trial.", 'detailedDescription': "Amongst people aged over 65, people with dementia (PWD) are much more likely to fall, and be injured, than those without dementia. Being injured from falling over is the main reason why older people attend the hospital A\\&E department. PWD often experience longer hospital stays following a fall, and may become confused which can be stressful for the carer; and a considerable cost to the NHS.\n\nThere is evidence that exercise programmes help to prevent falling. Can a Tai Chi exercise programme prevent falls among PWD living at home? We will investigate whether practising Tai Chi over several months improves dynamic postural balance (because it is a good indicator of how likely someone is to fall). People with mild to moderate dementia who live at home are eligible to take part with their regular care-giver as a 'pair'. We will recruit 150 pairs, i.e. 150 people with dementia and their informal caregiver (300 people in total). The PWD must be aged 18 years or older and both must be willing and able to do standing Tai Chi.\n\nAt baseline, the researcher will visit the pair at home to assess the participants' balance, memory skills, and general well-being. Pairs will be randomly assigned to either Tai Chi and usual care (intervention) or usual care only (control).\n\nPairs in the intervention group will practice Tai Chi together in a weekly group class held locally, and at home, and will complete a diary of how much time was spent doing Tai Chi over six months.\n\nAll participants will complete diaries showing how often they fell and whether falls caused an injury.\n\nThe baseline assessment will be repeated at six months. A researcher will collect feedback from the pair to see whether the intervention could be (further) tailored to the need of PWD and carers. The change in ability to balance over six months will be compared between PWD in each group."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nPerson with dementia:\n\n* Aged 18 or above\n* Living at home\n* Have a diagnosis of a dementia\n* Able to do standing Tai Chi (e.g. not be wheelchair bound)\n* Willing to attend weekly Tai Chi classes\n* Willing to attend a focus group (intervention pilot phase only)\n\nCarer:\n\n* Able to commit to supporting the PWD by participating in data collection throughout the study and in the intervention components if allocated to the intervention group (minimum of 2 times per week in-person, but ideally more)\n* Able to do standing Tai Chi (e.g. not be wheelchair bound)\n* Willing to attend weekly Tai Chi classes\n* Willing to attend a focus group (intervention pilot phase only)\n\nExclusion Criteria:\n\nPerson with dementia\n\n* Living in a care home\n* In receipt of palliative care\n* Indicate that they have:\n\n * Severe dementia\n * A Lewy body dementia or dementia with Parkinson's disease\n * Severe sensory impairment\n* Are already currently practising (on average once a week or more) or have been practising within the past six months (on average once a week or more) Tai Chi or similar exercise (Qigong, yoga, or Pilates)\n* Are currently under the care of or have been referred to a falls clinic for assessment, or are currently attending a balance exercise programme (e.g. Otago classes)\n* Lack mental capacity to provide informed consent\n\nCarer:\n\n* Indicate that they have severe sensory impairment\n* Lack mental capacity to provide informed consent"}, 'identificationModule': {'nctId': 'NCT02864056', 'acronym': 'TACIT', 'briefTitle': 'The TACIT Trial: TAi ChI for People With demenTia', 'organization': {'class': 'OTHER', 'fullName': 'Bournemouth University'}, 'officialTitle': 'A Randomised Controlled Trial Comparing the Effectiveness of Tai Chi Alongside Usual Care With Usual Care Alone on the Postural Balance of Community-dwelling People With Dementia', 'orgStudyIdInfo': {'id': 'TACIT001'}, 'secondaryIdInfos': [{'id': 'CDF-2015-08-030', 'type': 'OTHER_GRANT', 'domain': 'National Institute for Health Research'}, {'id': '16/WS/0139', 'type': 'OTHER', 'domain': 'United kingdom Reserach Ethics Committee'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Usual care'}, {'type': 'EXPERIMENTAL', 'label': 'Tai Chi', 'description': 'Completes 50 hours of Tai Chi, a combination of in-class and at-home practise.', 'interventionNames': ['Other: Tai Chi']}], 'interventions': [{'name': 'Tai Chi', 'type': 'OTHER', 'description': 'Ancient Chinese form of mind/body gentle exercise; this will be done while standing to improve postural balance.', 'armGroupLabels': ['Tai Chi']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BH12 4NB', 'city': 'Poole', 'state': 'Dorset', 'country': 'United Kingdom', 'facility': 'Memory Assessment Service, Dorset HealthCare University Foundation Trust', 'geoPoint': {'lat': 50.71429, 'lon': -1.98458}}, {'zip': 'PO3 6AD', 'city': 'Portsmouth', 'state': 'Hampshire', 'country': 'United Kingdom', 'facility': 'Solent NHS Trust', 'geoPoint': {'lat': 50.79899, 'lon': -1.09125}}, {'zip': 'SO30 3JB', 'city': 'Southampton', 'state': 'Hampshire', 'country': 'United Kingdom', 'facility': 'Memory Assessment and Research Centre, Southern Health NHS Foundation Trust', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}], 'overallOfficials': [{'name': 'Samuel Nyman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bournemouth University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "A Data Management Plan will be prepared to facilitate access, sharing and preservation. This will be explicitly referred to in the Statistical Analysis Plan and in the resultant publication of the main trial outcome. This will include specific detail of how potential bona fide research teams will be able to access the following from the CI's institution (Bournemouth University) online repository after an embargo period of approximately 24 months from the publication of the main trial outcome paper."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bournemouth University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Southern Health NHS Foundation Trust', 'class': 'OTHER'}, {'name': 'Dorset HealthCare University NHS Foundation Trust', 'class': 'OTHER'}, {'name': 'University of Plymouth', 'class': 'OTHER'}, {'name': 'National Institute for Health Research, United Kingdom', 'class': 'OTHER_GOV'}, {'name': 'University of Southampton', 'class': 'OTHER'}, {'name': 'Elemental Tai Chi', 'class': 'UNKNOWN'}, {'name': "Alzheimer's Society", 'class': 'OTHER'}, {'name': 'Solent NHS Trust', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Samuel Nyman', 'investigatorFullName': 'Samuel Nyman', 'investigatorAffiliation': 'Bournemouth University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-11-10', 'type': 'RELEASE'}, {'date': '2023-09-19', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Bournemouth University'}}}}