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

Primary Purpose

Accidental Falls

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Tai-chi group
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Accidental Falls focused on measuring Tai-chi, Dementia, Dyad approach, Fall prevention, Mobility

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Tai-chi group

Control group

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Recruitment rate
The number of dyads who provided consent to join the study over the eligible dyads
Attrition rate
The attrition rate was indicated by the percentage of dyads withdrawing from the study
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.
Occurrence of adverse events such as falls
Any adverse events at home were recorded.

Secondary Outcome Measures

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

Full Information

First Posted
November 8, 2017
Last Updated
November 9, 2017
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT03341091
Brief Title
Effects of Tai-chi Programme on Mobility of People With Dementia
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
November 1, 2016 (Actual)
Primary Completion Date
March 31, 2017 (Actual)
Study Completion Date
March 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Accidental Falls
Keywords
Tai-chi, Dementia, Dyad approach, Fall prevention, Mobility

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
An independent assessor who was blinded to group allocation assessed the participants' motor performance variables.
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tai-chi group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Tai-chi group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recruitment rate
Description
The number of dyads who provided consent to join the study over the eligible dyads
Time Frame
Enrollment date
Title
Attrition rate
Description
The attrition rate was indicated by the percentage of dyads withdrawing from the study
Time Frame
At the end of the 16-week programme
Title
Participants' adherence to practising Tai-chi at home and in the training sessions
Description
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.
Time Frame
Throughout the 16-week programme
Title
Occurrence of adverse events such as falls
Description
Any adverse events at home were recorded.
Time Frame
Throughout the 16-week programme and during the training sessions
Secondary Outcome Measure Information:
Title
Time measured in the Timed-up-and-Go test
Description
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.
Time Frame
Baseline, 8th week and 16th week from baseline
Title
Time measured in the Timed Chair Stand test
Description
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.
Time Frame
Baseline, 8th week and 16th week from baseline
Title
Length measured by the Functional Reach test
Description
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
Time Frame
Baseline, 8th week and 16th week from baseline
Title
Number of steps recorded in the Step Test
Description
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.
Time Frame
Baseline, 8th week and 16th week from baseline
Title
Focus interview groups
Description
Feedback from participants and their caregivers was collected by focus group within two weeks of completing the Tai-chi programme
Time Frame
17th week from baseline
Title
Menorah Park Engagement Scale
Description
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.
Time Frame
every week of the 16-week Tai-chi programme

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yat-wa Justina Liu
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Caritas Hong Kong - Services for the Elderly
City
Hong Kong
Country
Hong Kong
Facility Name
H.K.S.K.H. Lok Man Alice Kwok Integrated Service Centre
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
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Effects of Tai-chi Programme on Mobility of People With Dementia

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