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

November 9, 2017 updated by: Dr. Justina Liu Yat Wa, The Hong Kong Polytechnic University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Caritas Hong Kong - Services for the Elderly
      • Hong Kong, Hong Kong
        • H.K.S.K.H. Lok Man Alice Kwok Integrated Service Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria (for participants with dementia):

  • 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.

Inclusion Criteria (for caregivers):

  • 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 (for participants and caregivers):

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: Enrollment date
The number of dyads who provided consent to join the study over the eligible dyads
Enrollment date
Attrition rate
Time Frame: At the end of the 16-week programme
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
Time Frame: Throughout the 16-week programme
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
Time Frame: Throughout the 16-week programme and during the training sessions
Any adverse events at home were recorded.
Throughout the 16-week programme and during the training sessions

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time measured in the Timed-up-and-Go test
Time Frame: Baseline, 8th week and 16th week from baseline
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.
Baseline, 8th week and 16th week from baseline
Time measured in the Timed Chair Stand test
Time Frame: Baseline, 8th week and 16th week from baseline
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.
Baseline, 8th week and 16th week from baseline
Length measured by the Functional Reach test
Time Frame: Baseline, 8th week and 16th week from baseline
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
Baseline, 8th week and 16th week from baseline
Number of steps recorded in the Step Test
Time Frame: Baseline, 8th week and 16th week from baseline
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.
Baseline, 8th week and 16th week from baseline
Focus interview groups
Time Frame: 17th week from baseline
Feedback from participants and their caregivers was collected by focus group within two weeks of completing the Tai-chi programme
17th week from baseline
Menorah Park Engagement Scale
Time Frame: every week of the 16-week Tai-chi programme
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.
every week of the 16-week Tai-chi programme

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Investigators

  • Principal Investigator: Yat-wa Justina Liu, The Hong Kong Polytechnic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

March 31, 2017

Study Completion (Actual)

March 31, 2017

Study Registration Dates

First Submitted

November 8, 2017

First Submitted That Met QC Criteria

November 9, 2017

First Posted (Actual)

November 14, 2017

Study Record Updates

Last Update Posted (Actual)

November 14, 2017

Last Update Submitted That Met QC Criteria

November 9, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-ZZFT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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