NCT03341091

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 14, 2017

Completed
Last Updated

November 14, 2017

Status Verified

November 1, 2017

Enrollment Period

5 months

First QC Date

November 8, 2017

Last Update Submit

November 9, 2017

Conditions

Keywords

Tai-chiDementiaDyad approachFall preventionMobility

Outcome Measures

Primary Outcomes (4)

  • Recruitment rate

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

    Enrollment date

  • Attrition rate

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

    At the end of the 16-week programme

  • 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.

    Throughout the 16-week programme

  • Occurrence of adverse events such as falls

    Any adverse events at home were recorded.

    Throughout the 16-week programme and during the training sessions

Secondary Outcomes (6)

  • Time measured in the Timed-up-and-Go test

    Baseline, 8th week and 16th week from baseline

  • Time measured in the Timed Chair Stand test

    Baseline, 8th week and 16th week from baseline

  • Length measured by the Functional Reach test

    Baseline, 8th week and 16th week from baseline

  • Number of steps recorded in the Step Test

    Baseline, 8th week and 16th week from baseline

  • Focus interview groups

    17th week from baseline

  • +1 more secondary outcomes

Study Arms (2)

Tai-chi group

EXPERIMENTAL

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.

Other: Tai-chi group

Control group

NO INTERVENTION

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.

Interventions

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.

Tai-chi group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Caritas Hong Kong - Services for the Elderly

Hong Kong, Hong Kong

Location

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

Hong Kong, Hong Kong

Location

Related Publications (32)

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  • 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.

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Yat-wa Justina Liu

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
An independent assessor who was blinded to group allocation assessed the participants' motor performance variables.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 8, 2017

First Posted

November 14, 2017

Study Start

November 1, 2016

Primary Completion

March 31, 2017

Study Completion

March 31, 2017

Last Updated

November 14, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

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.

Locations