TACIT trial (TAi ChI for people with demenTia)

179 18 496 3 2135 document 496 1. 209193_Study Protocol v4.4_08.06.2018_clean_updated_31.07.2018.docx application/vnd.openxmlformats-officedocument.wordprocessingml.document 37ad249edadf869bf2386609178bf156 MD5 870874 2021-07-12 15:20:50 https://bordar.bournemouth.ac.uk/179/1/1.%20209193_Study%20Protocol%20v4.4_08.06.2018_clean_updated_31.07.2018.docx 179 1 1 application/vnd.openxmlformats-officedocument.wordprocessingml.document text Study protocol en public cc_by_nc_4

1. 209193_Study Protocol v4.4_08.06.2018_clean_updated_31.07.2018.docx

documentation 497 3 2137 document 497 2. TACIT STATISTICAL ANALYSIS PLAN signed-off Dec 2018.docx application/vnd.openxmlformats-officedocument.wordprocessingml.document aff2c9d23187c1908c4e6505d68b9231 MD5 539901 2021-07-12 15:20:57 https://bordar.bournemouth.ac.uk/179/2/2.%20TACIT%20STATISTICAL%20ANALYSIS%20PLAN%20signed-off%20Dec%202018.docx 179 2 2 application/vnd.openxmlformats-officedocument.wordprocessingml.document text Statistical analysis plan en public cc_by_nc_4

2. TACIT STATISTICAL ANALYSIS PLAN signed-off Dec 2018.docx

documentation 498 4 2139 document 498 3. CSV file of dataset.csv text/plain ab2377e142d288fe70e8255e95c71f47 MD5 75629 2021-07-12 15:21:02 https://bordar.bournemouth.ac.uk/179/3/3.%20CSV%20file%20of%20dataset.csv 179 3 3 text/plain spreadsheet Full dataset en staffonly cc_by_nc_4

3. CSV file of dataset.csv

dpa data 499 4 2141 document 499 3. FINAL_TACIT_DATABASE.sav application/octet-stream 463b822f432744c31ebba002b857ae2a MD5 53969 2021-07-12 15:21:07 https://bordar.bournemouth.ac.uk/179/4/3.%20FINAL_TACIT_DATABASE.sav 179 4 4 application/octet-stream spreadsheet Full dataset en staffonly cc_by_nc_4

3. FINAL_TACIT_DATABASE.sav

dpa data 500 1 2145 document 500 indexcodes.txt text/x-c++ d2ec5bb7543017d0a2be61a96b17d868 MD5 28471 2021-07-12 15:31:14 https://bordar.bournemouth.ac.uk/179/5/indexcodes.txt 179 5 5 text/x-c++ other Generate index codes conversion from text to indexcodes en public

indexcodes.txt

http://eprints.org/relation/isVersionOf https://bordar.bournemouth.ac.uk/id/document/496 http://eprints.org/relation/isVolatileVersionOf https://bordar.bournemouth.ac.uk/id/document/496 http://eprints.org/relation/isIndexCodesVersionOf https://bordar.bournemouth.ac.uk/id/document/496 501 1 2146 document 501 indexcodes.txt text/x-c++ 29ca857688ed972e26bef54964b43617 MD5 9366 2021-07-12 15:31:14 https://bordar.bournemouth.ac.uk/179/6/indexcodes.txt 179 6 6 text/x-c++ other Generate index codes conversion from text to indexcodes en public

indexcodes.txt

http://eprints.org/relation/isVersionOf https://bordar.bournemouth.ac.uk/id/document/497 http://eprints.org/relation/isVolatileVersionOf https://bordar.bournemouth.ac.uk/id/document/497 http://eprints.org/relation/isIndexCodesVersionOf https://bordar.bournemouth.ac.uk/id/document/497 502 2 2153 document 502 SPSS working file_PDF.doc.pdf application/pdf af6b9d34db68761dc32acf6d76b1e99b MD5 300626 2021-07-16 07:01:13 https://bordar.bournemouth.ac.uk/179/7/SPSS%20working%20file_PDF.doc.pdf 179 7 7 application/pdf text en public cc_by_nd_4

SPSS working file_PDF.doc.pdf

full_archive 503 2 2156 document 503 lightbox.jpg image/png 7b7e2f116f0a6f9284262d87768e0cd3 MD5 60606 2021-07-16 07:01:42 https://bordar.bournemouth.ac.uk/179/8/lightbox.jpg 179 8 8 image/png other Thumbnails conversion from text to thumbnail_lightbox en public

lightbox.jpg

preview.jpg

medium.jpg

small.jpg

indexcodes.txt

http://eprints.org/relation/isVersionOf https://bordar.bournemouth.ac.uk/id/document/502 http://eprints.org/relation/isVolatileVersionOf https://bordar.bournemouth.ac.uk/id/document/502 http://eprints.org/relation/isIndexCodesVersionOf https://bordar.bournemouth.ac.uk/id/document/502 archive 886 disk0/00/00/01/79 2021-11-16 15:33:35 2021-11-16 15:51:22 2021-11-16 15:33:35 data_collection show Nyman Samuel snyman@bournemouth.ac.uk TACIT trial (TAi ChI for people with demenTia) pub ihcs Accidental falls, Behaviour change, Caregiver, Clinical trial, Dementia, Exercise, Feasibility, Postural balance, Tai chi 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) 2019-09-26 published Dove Medical Press https://www.dovepress.com/randomised-controlled-trial-of-the-effect-of-tai-chi-on-postural-balan-peer-reviewed-fulltext-article-CIA 10.18746/bmth.data.00000179 Trial dataset Bournemouth University is the holder of the data. bordar@bournemouth.ac.uk Chief Investigator Nyman Samuel snyman@bournemouth.ac.uk Randomised Controlled Trial Of The Effect Of Tai Chi On Postural Balance Of People With Dementia pub https://doi.org/10.2147/CIA.S228931 DOI pub The TACIT Trial: TAi ChI for people with demenTia web https://www.bournemouth.ac.uk/research/projects/tacit-trial-tai-chi-people-dementia pub National Institute for Health Research (NIHR) CDF-2015-08-030 From published protocol: Background: Falls are a public health issue for the older adult population and more so for people with dementia (PWD). Compared with their cognitively intact peers, PWD are at higher risk of falls and injurious falls. This randomised controlled trial aims to test the clinical and cost effectiveness of Tai Chi to improve postural balance among community-dwelling PWD and to assess the feasibility of conducting a larger definitive trial to reduce the incidence of falls among PWD. Methods: A 3-centre parallel group randomised controlled trial with embedded process evaluation. One hundred and fifty community-dwelling dyads of a person with dementia and their informal carer will be recruited and assessed at baseline and at six-month follow-up. Dyads will be randomised in a 1:1 ratio to either usual care or usual care plus a Tai Chi intervention for 20 weeks. The Tai Chi intervention will consist of weekly classes (45 min’ Tai Chi plus up to 45 min for informal discussion, with up to 10 dyads per class) and home-based exercises (20 min per day to be facilitated by the carer). Home practice of Tai Chi will be supported by the use of behaviour change techniques with the Tai Chi instructor at a home visit in week 3–4 of the intervention (action planning, coping planning, self-monitoring, and alarm clock reminder) and at the end of each class (feedback on home practice). The primary outcome is dynamic balance measured using the Timed Up and Go test, coinciding with the end of the 20-week intervention phase for participants in the Tai Chi arm. Secondary outcomes for PWD include functional balance, static balance, fear of falling, global cognitive functioning, visual-spatial cognitive functioning, quality of life, and falls. Secondary outcomes for carers include dynamic balance, static balance, quality of life, costs, and carer burden. Discussion: This trial is the first in the UK to test the effectiveness of Tai Chi to improve balance among PWD. The trial will inform a future study that will be the first in the world to use Tai Chi in a trial to prevent falls among PWD. Trial registration: NCT02864056. Anonymised electronic records and paper copies of records will be open to inspection and monitoring from a recognised representative from either the Sponsor, Bournemouth University, the CTU, or the funder (National Institute for Health Research). The trial management group will have access to the full dataset. Other interested parties may make a formal request to access the electronic dataset, which will be approved / declined by the CI in accordance with the Data Management Plan that will detail management of access, sharing, and preservation of the data. Any use of the electronic data set must comply with the dissemination policy (see below) and be requested via Bournemouth University Library (bordar@bournemouth.ac.uk) who will collaborate with the CI with regards to access. Non-digital data supporting this study will be stored by the corresponding author at Bournemouth University. Only electronic data will be shared with bona fide researchers intending to use the data for non-commercial research purposes, after an embargo period of approximately 24 months. Access to the following will be restricted to researchers who sign a confidentiality agreement and confirm their intention to use the data is for secondary data analysis for non-commercial research purposes using a Creative Commons licence: statistical analysis plan; where applicable, statistical code (for final analysis of primary outcome measure); and anonymised participant-level dataset and data documentation. 2017-04-06 2018-07-17