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Accidental FallsNCT03341091

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

A study testing Tai-chi group in people with Accidental Falls, run by The Hong Kong Polytechnic University at 2 sites in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Accidental Falls
What is being tested?
Tai-chi group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
2 sitesHong Kong
Study dates
1 Nov 2016to 31 Mar 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Hong Kong2 sites

  • Caritas Hong Kong - Services for the Elderly

    Hong Kong

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

    Hong Kong

Other trials in Hong Kong

About this study

Official title: The Effects of Simplified 10-step Tai-chi Programme on the Motor Performance and Fall Prevention of Community-dwelling Older People With Dementia: a Pilot Cluster Randomized Control Trial

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.

Read the detailed description

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.

Being tested
Tai-chi group
Keywords
Tai-chi, Dementia, Dyad approach, Fall prevention, Mobility
Medical subject headings
Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tai-chi groupOther

    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.

Study groups in NCT03341091
Study groupRoleWhat they receive
Tai-chi groupExperimental16-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.
Receives: Other: Tai-chi group
Control groupNo interventionGroup 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment rate

    The number of dyads who provided consent to join the study over the eligible dyads

    Measured: Enrollment date

  2. Attrition rate

    The attrition rate was indicated by the percentage of dyads withdrawing from the study

    Measured: At the end of the 16-week programme

  3. Participants' adherence to practising Tai-chi at home and in the training sessions

    Exercise adherence (Tai-chi group only) was assessed by both the exercise diaries and training session attendance. Caregivers were instructed to record participants' adherence in terms of the frequency and duration of their Tai-chi home practice in a weekly exercise diary.

    Measured: Throughout the 16-week programme

  4. Occurrence of adverse events such as falls

    Any adverse events at home were recorded.

    Measured: Throughout the 16-week programme and during the training sessions

Secondary outcomes (6)

  1. Time measured in the Timed-up-and-Go test

    The Timed-up-and-Go test assess mobility of the participants. The time taken by participants to execute the tasks - stand up from a standard chair, walk three meters, turn around, walk back to the chair and sit down - was recorded in seconds.

    Measured: Baseline, 8th week and 16th week from baseline

  2. Time measured in the Timed Chair Stand test

    Timed Chair Stand test assesses functional lower limb muscle strength of the participant. Each participant was instructed to stand up fully and sit down five times as quickly as possible. The time needed to complete this task was recorded.

    Measured: Baseline, 8th week and 16th week from baseline

  3. Length measured by the Functional Reach test

    Functional Reach test assessed the dynamic bilateral stance balance of the participants. Participants stood beside a wall with their dominant arm raised to 90 degrees. They were then instructed to lean forward as far as possible, with the hand remaining at shoulder level. The Functional Reach score was the additional reach of the raised hand from the starting position in centimeters

    Measured: Baseline, 8th week and 16th week from baseline

  4. Number of steps recorded in the Step Test

    The Step Test assesses the dynamic single leg standing balance of the participants. Participants stood with their feet parallel and apart. They were instructed to place one whole foot onto the 5 centimetre-high block in front of them and then return it fully back down to the floor repeatedly as fast as possible, for 15 seconds. Each leg was tested separately, and performance on the side with the least number of steps was the recorded result.

    Measured: Baseline, 8th week and 16th week from baseline

  5. Focus interview groups

    Feedback from participants and their caregivers was collected by focus group within two weeks of completing the Tai-chi programme

    Measured: 17th week from baseline

  6. Menorah Park Engagement Scale

    The engagement of participants with dementia when attending the Tai-chi training sessions was assessed by four items extracted from the Menorah Park Engagement Scale. The four items are constructive engagement, passive engagement, self/other engagement, and non-engagement. Each item was rated on a three-point Likert scale (i.e., 0 = "not observed", 1 = "up to half the observation", and 2 = "more than half of the observation"). In addition, Engagement was also rated by the Tai-chi master on a 4-item scale (i.e. engagement during class, following proper steps, satisfaction with participants' learning progress, and satisfaction with participants' performance) based on the Tai-chi instructor's in-class observation. Each item was quantified on a 10-point Likert scale, with higher scores representing a greater degree of engagement.

    Measured: every week of the 16-week Tai-chi programme

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2017
  2. Study start1 Nov 2016
  3. Primary completion31 Mar 2017
  4. Study completion31 Mar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03341091
Sponsor's protocol ID
4-ZZFT
Status last verified
Nov 2017
First submitted
8 Nov 2017
Last updated
14 Nov 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: For confidentiality, the data will be kept anonymous and the names of all participants including the caregivers will be replaced by reference codes. The data collected will be kept in a locked place and electronic versions will be encrypted, and only be accessible by the researchers. All data will be destroyed within 3 years after the completion of this research.

Publications

  • 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.

    PubMed 26553485

  • 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.

    PubMed 26063472

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

  • 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.

    PubMed 22374645

  • 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.

    PubMed 19370674

  • 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.

  • 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.

    PubMed 20558197

  • 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.

    PubMed 25497683

  • 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.

    PubMed 25650522

  • 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.

    PubMed 22517441

  • 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.

    PubMed 18586136

  • 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.

    PubMed 12521968

  • 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.

    PubMed 10023893

  • 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.

    PubMed 24218145

  • 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.

    PubMed 22272562

Questions about this trial

What is this clinical trial studying?

A study testing Tai-chi group in people with Accidental Falls, run by The Hong Kong Polytechnic University at 2 sites in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment rate (time frame: Enrollment date). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03341091, which also lists 32 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2017.

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