Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00171

2 Trial Registration Date

2009-04-23

i Registration Status

Retrospective

3 Secondary IDs

05060501

4 Source(s) of Funding

Health and Health Services Research Fund

5 Primary Sponsor

Department of Psychiatry, the Chinese University of Hong Kong

6 Secondary Sponsor

Elderly Health Services, Department of Health, the Government of the Hong Kong SAR

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Billy ML Wong

ii Address

G/F, Department of Psychiatry, the Chinese University of Hong Kong, Tai Po Hospital, Tai Po, NT, Hon

iii Phone

iv Email

v Affiliation

Project OT, Department of Psychiatry, the Chinese University of Hong Kong

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Linda CW Lam

ii Address

G/F, Department of Psychiatry, the Chinese University of Hong Kong, Tai Po Hospital, Tai Po, NT, Hon

iii Phone

iv Email

v Affiliation

Department of Psychiatry, the Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

A Randomized Controlled Trial of the Effectiveness of Traditional Chinese Style Physical Exercise (Tai Chi) in the Maintenance of Cognitive and Functional Abilities in Subjects with Mild Cognitive Impairment

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

A RCT of Tai Chi on Cognitive Function in Mild Cognitive Impairment

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2006-02-02

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Mild Cognitive Impairment

15 Intervention

i Types of intervention

Behavior

Please specify

ii Description/ name of Intervention/article

24 style Tai Chi exercise

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

12 months

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Muscle stretching exercise developed by physiotherapists at the department of Health of Hong Kong SAR.

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

The Inclusion criteria are :
1. Subjects over 65 years old will be recruited from the centres at the Elderly Health Services (EHS) of the Department of Health (DH), District Elderly Community Centre (DECC) and residential homes (OAH) for the elderly.
2. Subjects satisfying international consensus criteria for MCI will be selected for further screening (listed below)(1).
3. Subjects assessed to be physically fit for training will be considered for recruitment.
4. For subjects with compromised motility, they will be assessed by an allied health professional for physical fitness of practising Tai Chi before recruitment.

ii Exclusion Criteria

The exclusion criteria are :
1. Subjects with clinical diagnosis of dementia
2. Subjects prescribed with anti-dementia agent for individual specific purposes.
3. Subjects with greatly impaired communication and language abilities.
4. Subjects with moderate to high risk of falls as assessed by the research therapist.
5. For subjects with unstable medical condition, the training will be suspended until their medical conditions became stabilized.
6. Subjects with daily practice of Tai Chi and other mind body exercise for over 6 months will be excluded to reduce confounding effects of pre-existing exercise.

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2008-04-01

21 Target Sample Size

520

22 Recruitment Status

Recruiting

23 Primary Outcome

1. Clinical Dementia Rating (CDR) will be used as the primary intervention outcome – Upon recruitment, the subjects should satisfy criteria for MCI and the CDR should only be less than 1. Deterioration from MCI to CDR 1 or more would indicate progression to clinical dementia. The subjects will be categorized as ‘converters’. The primary outcome indicator would be the rate of ‘conversion’ to dementia (CDR 1 or more) compared between the intervention and control group after one year.
2. Cognitive test scores will be used as the primary intervention outcome – A composite z score of the baseline cognitive test scores would be computed using the cognitive tests mentioned. A difference in the change in z scores from the baseline between the intervention and control groups will be a primary outcome indicator.
3. Disability Assessment for Dementia (DAD) will be used as the primary intervention outcome – As functioning maintenance will be an important outcome of the Tai Chi exercise, the difference in the change of DAD scores will be a primary outcome indicator.

24 Secondary Outcome

1. Berg Balance Scale (BBS) will be used as the secondary outcome indicator – the difference in BBS between intervention and control groups over the intervention period will be evaluated as a secondary outcome indicator.
2. Neuropsychiatric Inventory (NPI) will be used as the intervention outcome– The difference in prevalence of motivational mood symptoms (depression, apathy, anxiety) between the intervention and control groups after one year will be adopted as outcome indicator.
3. Cornell Scale for Depression in Dementia (CSDD) will be used as the secondary intervention outcome for Hypothesis 4 – The change in CSDD scores will represent a change in the level of mood symptoms. Comparison of the change in CSDD scores between the intervention and control groups will constitute the secondary outcome indicator.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2009-11-23

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

NA

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Trial History Detail on 2009-11-19