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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03341091
Recruitment Status : Completed
First Posted : November 14, 2017
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Justina Liu Yat Wa, The Hong Kong Polytechnic University

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.


Condition or disease Intervention/treatment Phase
Accidental Falls Other: Tai-chi group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Outcomes Assessor)
Masking Description: An independent assessor who was blinded to group allocation assessed the participants' motor performance variables.
Primary Purpose: Supportive Care
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
Actual Study Start Date : November 1, 2016
Actual Primary Completion Date : March 31, 2017
Actual Study Completion Date : March 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia Falls

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.




Primary Outcome Measures :
  1. Recruitment rate [ Time Frame: Enrollment date ]
    The number of dyads who provided consent to join the study over the eligible dyads

  2. 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

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03341091


Locations
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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
Hong Kong, Hong Kong
Sponsors and Collaborators
The Hong Kong Polytechnic University
Investigators
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Principal Investigator: Yat-wa Justina Liu The Hong Kong Polytechnic University
  Study Documents (Full-Text)

Documents provided by Dr. Justina Liu Yat Wa, The Hong Kong Polytechnic University:
Informed Consent Form  [PDF] May 16, 2016
Statistical Analysis Plan  [PDF] May 16, 2016
Study Protocol  [PDF] May 16, 2016

Publications:
Taylor ME, Delbaere K, Close JC, et al. Managing falls in older patients with cognitive impairment. Aging Health 2012; 8: 573-588.
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.
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.
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.
Hill K, Denisenko S, Miller K, et al. Clinical outcome measurement in adult neurological physiotherapy. Victoria: Australian Physiotherapy Association National Neurology Group 2005.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Justina Liu Yat Wa, Associate Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT03341091    
Other Study ID Numbers: 4-ZZFT
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Justina Liu Yat Wa, The Hong Kong Polytechnic University:
Tai-chi
Dementia
Dyad approach
Fall prevention
Mobility
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders