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Trial History Detail on 2009-11-19

CUHK_CCT00171

2009-04-23

Retrospective

05060501

Health and Health Services Research Fund

Department of Psychiatry, the Chinese University of Hong Kong

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

Billy ML Wong

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

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

Linda CW Lam

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

Department of Psychiatry, the Chinese University of Hong Kong

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

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

Yes

2006-02-02

Mild Cognitive Impairment

Behavior

24 style Tai Chi exercise

12 months

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

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.

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.

Randomized

Active

Single-blind

Parallel

2008-04-01

520

Recruiting

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.


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.

No

2009-11-23


Yes

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