Effects of Tai-chi Programme on Mobility of People With Dementia

NCT ID: NCT03341091

Last Updated: 2017-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-01

Study Completion Date

2017-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study evaluates the feasibility and the preliminary effects of a simplified 10-step Tai-chi programme (a dyadic approach) on the mobility performance of people with mild to moderate dementia.

Four community health centres were recruited and each was randomised to either the intervention group (Tai-chi) or the control group. Tai-chi group received a 16-week 10-step simplified Tai-chi training programme in which additional measures were implemented to enhance participants' engagement. The control group took part in group recreational activities organized by the community centres.

It was hypothesized that the Tai-chi group would outperform the control group regarding their mobility performance.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Four community health centres that provide dementia care services were recruited through convenience sampling. Each was viewed as one cluster and was randomized to either the Tai-chi or the control group, based on computer-generated random numbers prepared by an independent statistician.

Participants allocated to the Tai-chi group took part in the 16-week 10-step simplified Tai-chi programme, which was derived from the traditional Yang style and has been proven to be effective in enhancing older people's balance and mobility. Each week, the dyads attended two 1-hour sessions of centre-based Tai-chi training and practised at least three 30-minute Tai-chi sessions at home. Additional measures targeted cognitively impaired people were implemented to promote engagement, including the adoption of multiple sensory cues, slow and relaxed practice, a dyadic approach, and positive emotional motivation techniques.

Participants allocated to the control group took part in group recreational activities such as watching movies or listening to music, which was organized by the community centres with similar frequency and duration of the Tai-chi sessions that were organized for the Tai-chi group. The control group participants were instructed to continue their usual lifestyles and levels of physical activity.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Accidental Falls

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Tai-chi Dementia Dyad approach Fall prevention Mobility

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A two-arm parallel (single-blinded) cluster randomised controlled trial involves two groups of participants (Tai-chi and the control group). Four community health centers that provide dementia care services were recruited through convenience sampling and each was viewed as one cluster and was randomised to either the Tai-chi or the control group, based on computer-generated random numbers. So during the trial, participants in one group receive Tai-chi group programme "in parallel" to participants in the other group, who took part in group recreational activities and continue their usual lifestyles and levels of physical activity.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
An independent assessor who was blinded to group allocation assessed the participants' motor performance variables.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Tai-chi group

16-week 10-step simplified Tai-chi programme.

Two 1-hour sessions of centre-based Tai-chi training and a minimum of three 30-minute Tai-chi sessions at home on a weekly basis.

Group Type EXPERIMENTAL

Tai-chi group

Intervention Type OTHER

The Tai-chi group received a 16-week 10-step simplified Tai-chi training programme in which additional measures were implemented to enhance participants' engagement.

Control group

Group recreational activities and continue their usual lifestyles and levels of physical activity as usual for 16 weeks.

Two 1-hour sessions of group recreational activities on a weekly basis.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tai-chi group

The Tai-chi group received a 16-week 10-step simplified Tai-chi training programme in which additional measures were implemented to enhance participants' engagement.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* community-dwelling older people aged \> 60 years;
* able to walk independently with no walking aid or no more than a single point stick for at least 10 minutes to ensure their mobility was good enough for taking part in the Tai-chi training;
* formally diagnosed with a form of dementia;
* classified with mild to moderate severity of dementia, assessed by the Montreal Cognitive Assessment 5-minute scale with a cut-off score at the 16th percentile according to participants' age and education; and
* able to identify a caregiver who was willing to work as an exercise partner for their Tai-chi practice.


* adults aged \> 18;
* living with the participants or actively involved in their daily care;
* sufficiently mobile to be able to take part in the Tai-chi training together with the participants; and
* willing to work as an exercise partner with the participants and monitor and encourage them to practice Tai-chi at home.

Exclusion Criteria

if at the time of and three months before recruitment, they

* had any diseases that might severely affect their balance and coordination, such as Parkinson's disease or myasthenia gravis;
* were hospitalized due to acute illnesses such as myocardial infarction, stroke or hip fracture, or had major surgeries;
* reported that they regularly performed moderately intensive exercise, such as hiking or Tai-chi, for more than 2 hours per week;
* had terminal illnesses such as cancer and were in palliative care; or
* had severe visual or hearing impairment.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Justina Liu Yat Wa

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yat-wa Justina Liu

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Caritas Hong Kong - Services for the Elderly

Hong Kong, , Hong Kong

Site Status

H.K.S.K.H. Lok Man Alice Kwok Integrated Service Centre

Hong Kong, , Hong Kong

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Hong Kong

References

Explore related publications, articles, or registry entries linked to this study.

Kim SH. Risk factors for severe injury following indoor and outdoor falls in geriatric patients. Arch Gerontol Geriatr. 2016 Jan-Feb;62:75-82. doi: 10.1016/j.archger.2015.10.003. Epub 2015 Oct 22.

Reference Type BACKGROUND
PMID: 26553485 (View on PubMed)

Global Burden of Disease Study 2013 Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 301 acute and chronic diseases and injuries in 188 countries, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015 Aug 22;386(9995):743-800. doi: 10.1016/S0140-6736(15)60692-4. Epub 2015 Jun 7.

Reference Type BACKGROUND
PMID: 26063472 (View on PubMed)

Taylor ME, Delbaere K, Close JC, et al. Managing falls in older patients with cognitive impairment. Aging Health 2012; 8: 573-588.

Reference Type BACKGROUND

Muir SW, Gopaul K, Montero Odasso MM. The role of cognitive impairment in fall risk among older adults: a systematic review and meta-analysis. Age Ageing. 2012 May;41(3):299-308. doi: 10.1093/ageing/afs012. Epub 2012 Feb 27.

Reference Type BACKGROUND
PMID: 22374645 (View on PubMed)

Gillespie LD, Robertson MC, Gillespie WJ, Lamb SE, Gates S, Cumming RG, Rowe BH. Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD007146. doi: 10.1002/14651858.CD007146.pub2.

Reference Type BACKGROUND
PMID: 19370674 (View on PubMed)

Harling A and Simpson JP. A systematic review to determine the effectiveness of Tai Chi in reducing falls and fear of falling in older adults. Physical Therapy Reviews 2008; 13: 237-248.

Reference Type BACKGROUND

Logghe IH, Verhagen AP, Rademaker AC, Bierma-Zeinstra SM, van Rossum E, Faber MJ, Koes BW. The effects of Tai Chi on fall prevention, fear of falling and balance in older people: a meta-analysis. Prev Med. 2010 Sep-Oct;51(3-4):222-7. doi: 10.1016/j.ypmed.2010.06.003. Epub 2010 Jun 15.

Reference Type BACKGROUND
PMID: 20558197 (View on PubMed)

Huang Y, Liu X. Improvement of balance control ability and flexibility in the elderly Tai Chi Chuan (TCC) practitioners: a systematic review and meta-analysis. Arch Gerontol Geriatr. 2015 Mar-Apr;60(2):233-8. doi: 10.1016/j.archger.2014.10.016. Epub 2014 Nov 18.

Reference Type BACKGROUND
PMID: 25497683 (View on PubMed)

Song R, Ahn S, So H, Lee EH, Chung Y, Park M. Effects of t'ai chi on balance: a population-based meta-analysis. J Altern Complement Med. 2015 Mar;21(3):141-51. doi: 10.1089/acm.2014.0056. Epub 2015 Feb 4.

Reference Type BACKGROUND
PMID: 25650522 (View on PubMed)

Yao L, Giordani BJ, Algase DL, You M, Alexander NB. Fall risk-relevant functional mobility outcomes in dementia following dyadic tai chi exercise. West J Nurs Res. 2013 Mar;35(3):281-96. doi: 10.1177/0193945912443319. Epub 2012 Apr 19.

Reference Type BACKGROUND
PMID: 22517441 (View on PubMed)

Liu-Ambrose T, Ahamed Y, Graf P, Feldman F, Robinovitch SN. Older fallers with poor working memory overestimate their postural limits. Arch Phys Med Rehabil. 2008 Jul;89(7):1335-40. doi: 10.1016/j.apmr.2007.11.052.

Reference Type BACKGROUND
PMID: 18586136 (View on PubMed)

Shaw FE, Bond J, Richardson DA, Dawson P, Steen IN, McKeith IG, Kenny RA. Multifactorial intervention after a fall in older people with cognitive impairment and dementia presenting to the accident and emergency department: randomised controlled trial. BMJ. 2003 Jan 11;326(7380):73. doi: 10.1136/bmj.326.7380.73.

Reference Type BACKGROUND
PMID: 12521968 (View on PubMed)

Close J, Ellis M, Hooper R, Glucksman E, Jackson S, Swift C. Prevention of falls in the elderly trial (PROFET): a randomised controlled trial. Lancet. 1999 Jan 9;353(9147):93-7. doi: 10.1016/S0140-6736(98)06119-4.

Reference Type BACKGROUND
PMID: 10023893 (View on PubMed)

Meyer C, Hill S, Dow B, Synnot A, Hill K. Translating Falls Prevention Knowledge to Community-Dwelling Older PLWD: A Mixed-Method Systematic Review. Gerontologist. 2015 Aug;55(4):560-74. doi: 10.1093/geront/gnt127. Epub 2013 Nov 11.

Reference Type BACKGROUND
PMID: 24218145 (View on PubMed)

Small JA. A new frontier in spaced retrieval memory training for persons with Alzheimer's disease. Neuropsychol Rehabil. 2012;22(3):329-61. doi: 10.1080/09602011.2011.640468. Epub 2012 Jan 24.

Reference Type BACKGROUND
PMID: 22272562 (View on PubMed)

Burgener SC, Yang Y, Gilbert R, Marsh-Yant S. The effects of a multimodal intervention on outcomes of persons with early-stage dementia. Am J Alzheimers Dis Other Demen. 2008 Aug-Sep;23(4):382-94. doi: 10.1177/1533317508317527. Epub 2008 May 4.

Reference Type BACKGROUND
PMID: 18453642 (View on PubMed)

Tsai PF, Chang JY, Beck C, Kuo YF, Keefe FJ. A pilot cluster-randomized trial of a 20-week Tai Chi program in elders with cognitive impairment and osteoarthritic knee: effects on pain and other health outcomes. J Pain Symptom Manage. 2013 Apr;45(4):660-9. doi: 10.1016/j.jpainsymman.2012.04.009. Epub 2012 Sep 24.

Reference Type BACKGROUND
PMID: 23017610 (View on PubMed)

Lam LC, Chau RC, Wong BM, Fung AW, Lui VW, Tam CC, Leung GT, Kwok TC, Chiu HF, Ng S, Chan WM. Interim follow-up of a randomized controlled trial comparing Chinese style mind body (Tai Chi) and stretching exercises on cognitive function in subjects at risk of progressive cognitive decline. Int J Geriatr Psychiatry. 2011 Jul;26(7):733-40. doi: 10.1002/gps.2602. Epub 2010 Dec 9.

Reference Type BACKGROUND
PMID: 21495078 (View on PubMed)

Yao L, Giordani B, Alexander NB. Developing a positive emotion-motivated Tai Chi (PEM-TC) exercise program for older adults with dementia. Res Theory Nurs Pract. 2008;22(4):241-55.

Reference Type BACKGROUND
PMID: 19093662 (View on PubMed)

Chang JY, Tsai PF, Woods S, Beck C, Roberson PK, Rosengren K. Teaching Tai Chi to elders with osteoarthritis pain and mild cognitive impairment. Am J Recreat Ther. 2011 Winter;10(1):11-16.

Reference Type BACKGROUND
PMID: 25242898 (View on PubMed)

Liu YW, Tsui CM. A randomized trial comparing Tai Chi with and without cognitive-behavioral intervention (CBI) to reduce fear of falling in community-dwelling elderly people. Arch Gerontol Geriatr. 2014 Sep-Oct;59(2):317-25. doi: 10.1016/j.archger.2014.05.008. Epub 2014 May 29.

Reference Type BACKGROUND
PMID: 24953768 (View on PubMed)

Tinetti ME, Powell L. Fear of falling and low self-efficacy: a case of dependence in elderly persons. J Gerontol. 1993 Sep;48 Spec No:35-8. doi: 10.1093/geronj/48.special_issue.35. No abstract available.

Reference Type BACKGROUND
PMID: 8409238 (View on PubMed)

Judge KS, Camp CJ and Orsulic-Jeras S. Use of Montessori-based activities for clients with dementia in adult day care: Effects on engagement. American Journal of Alzheimer's Disease 2000; 15: 42-46.

Reference Type BACKGROUND

Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.

Reference Type BACKGROUND
PMID: 1991946 (View on PubMed)

Hatch J, Gill-Body KM, Portney LG. Determinants of balance confidence in community-dwelling elderly people. Phys Ther. 2003 Dec;83(12):1072-9.

Reference Type BACKGROUND
PMID: 14640866 (View on PubMed)

Whitney SL, Wrisley DM, Marchetti GF, Gee MA, Redfern MS, Furman JM. Clinical measurement of sit-to-stand performance in people with balance disorders: validity of data for the Five-Times-Sit-to-Stand Test. Phys Ther. 2005 Oct;85(10):1034-45.

Reference Type BACKGROUND
PMID: 16180952 (View on PubMed)

Duncan PW, Weiner DK, Chandler J, Studenski S. Functional reach: a new clinical measure of balance. J Gerontol. 1990 Nov;45(6):M192-7. doi: 10.1093/geronj/45.6.m192.

Reference Type BACKGROUND
PMID: 2229941 (View on PubMed)

Hill KD, Bernhardt J, McGann AM, et al. A new test of dynamic standing balance for stroke patients: reliability, validity and comparison with healthy elderly. Physiotherapy Canada 1996; 48: 257-262.

Reference Type BACKGROUND

Hill K, Denisenko S, Miller K, et al. Clinical outcome measurement in adult neurological physiotherapy. Victoria: Australian Physiotherapy Association National Neurology Group 2005.

Reference Type BACKGROUND

Suttanon P, Hill KD, Dodd KJ, Said CM. Retest reliability of balance and mobility measurements in people with mild to moderate Alzheimer's disease. Int Psychogeriatr. 2011 Sep;23(7):1152-9. doi: 10.1017/S1041610211000639. Epub 2011 Apr 14.

Reference Type BACKGROUND
PMID: 21489342 (View on PubMed)

Suttanon P, Hill KD, Said CM, Williams SB, Byrne KN, LoGiudice D, Lautenschlager NT, Dodd KJ. Feasibility, safety and preliminary evidence of the effectiveness of a home-based exercise programme for older people with Alzheimer's disease: a pilot randomized controlled trial. Clin Rehabil. 2013 May;27(5):427-38. doi: 10.1177/0269215512460877. Epub 2012 Nov 1.

Reference Type BACKGROUND
PMID: 23117349 (View on PubMed)

Liu JYW, Kwan RYC, Lai CK, Hill KD. A simplified 10-step Tai-chi programme to enable people with dementia to improve their motor performance: a feasibility study. Clin Rehabil. 2018 Dec;32(12):1609-1623. doi: 10.1177/0269215518786530. Epub 2018 Jul 4.

Reference Type DERIVED
PMID: 29969916 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

4-ZZFT

Identifier Type: -

Identifier Source: org_study_id