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Trial History Detail on 2011-06-30

CUHK_CCT00284

2011-05-12

Retrospective

Nil

Simon KY Lee Fund for the Elderly

Simon KY Lee Fund for the Elderly

Not applicable

Karin Ngai魏智珊

Department of Psychiatry, G/F, Multi-Centre, Tai Po Hospital, Tai Po, New Territories, Hong Kong

26076051

ngaics@cuhk.edu.hk

Department of Psychiatry, the Chinese University of Hong Kong

Linda CW Lam林翠華

Department of Psychiatry, G/F, Multi-Centre, Tai Po Hospital, Tai Po, New Territories, Hong Kong

26076040

cwlam@cuhk.edu.hk

Department of Psychiatry, the Chinese University of Hong Kong

A randomized controlled trial of leisure activity intervention on preservation of cognitive and everyday function in Chinese older adults with early cognitive decline

A randomized controlled trial of leisure activity intervention on preservation of cognitive and everyday function in Chinese older adults with early cognitive decline

A clinical trial of activity intervention on cognitive function for Chinese older adults

Hong Kong, China

Yes

2011-03-28

Mild Cognitive Impairment and Pre-mild Cognitive Impairment

Behavior

This will be a Single Blind Randomized Controlled Trial of 12 months duration. Chinese adults (aged 60 or above) with mild cognitive decline (Mild Cognitive Impairment [MCI] and pre-MCI) will be randomized into four intervention groups with 150 subjects per arm. The intervention groups comprised of cognitive (C), physical (P), cognitive-physical (CP) and social (S) programs. Each participant will participate in regular activities arranged by the participating elderly centres.

One Year

The comparative treatment will be social intervention as stated below.
Research Plan
This study will adopt a single blind randomized control trial design of 12 month duration.

Description of treatments
The format of intervention would be in groups organized at the social centres. For each intervention group, the following schedule would be adopted.
1. The Social (S) group will serve as the controlled arm. Groups randomized as S would comprise of social activities selected. For any week, at least 3 social groups of one hour duration should be arranged for the participants.
2. The Cognitive (C) group will be trained with cognitive stimulating activities. Groups randomized as C would comprise of cognitive activities selected from Appendix 2. For any week, at least 3 cognitive groups of one hour duration each should be arranged.
3. The Physical (P) group will have training on physical exercise. Groups randomized as P would comprise of physical activities selected from Appendix 2. In order to capture the benefits of different modalities of physical exercise, participants will be arranged with physical exercise program with 1 type of stretching & toning exercise, 1 type of mind body exercise and 1 type of aerobic exercise for one hour duration in any one week.
4. The Cognitive-Physical (CP) group will have training on both physical exercise and cognitive activities. Groups assigned as CP would comprise of 2 types of cognitive activities with 1 type of mind body physical exercise. Alternatively, the activity combination may be consisted of 1 type of cognitive activities with 2 types of mind body physical exercise. The activity list will be selected by the appropriate categories as stipulated. For any week, at least 3 activity groups of one hour duration each should be arranged.


Intervention schedule
For each group, the centre will provide training and facilities for programs at least once per day with frequency three times per week during the one year intervention period. Participants are also encouraged to carry out activities at home at their leisure. A log book will be used to keep track of the compliance. The centre staffs will keep track of attendance and phone up participants every two weeks, participants who do not follow the schedule will be actively followed up.

1. Subjects 60 years or above.
2. Satisfied criteria for MCI and pre-MCI by a cognitive screening package
3. Physically fit with low risks of fall as assessed by the research team.

1. Clinical dementia with a Clinical Dementia Rating, CDR >=1;
2. Already been prescribed with anti-dementia medication.

60 years

Not applicable

Both Male and Female

Interventional

Randomized

Active

Single-blind

Parallel

2011-04-21

600

Recruiting

Clinical Dementia Rating (CDR) sum of boxes scores. CDR is a semi-structured clinical interview for assessment of global cognitive ability. Six areas are assessed to give an overall rating of global cognition (0, not demented; 0.5, very mild dementia; 1 to 3, mild to severe dementia). The sum of boxes refers to summative scores of the six domains of everyday cognition and functioning measured in CDR (orientation, memory, judgment, habits and hobbies, self care and community activities). It is sensitive to capture functional deterioration of dementia at the earliest changes.

1. Cognitive assessment included the list learning test, digit span, visual span, category verbal fluency (CVFT) and trail making tests.
2. Subjective cognitive complaints (SCC) were determined by the Memory Inventory for the Chinese (MIC). It is a 22 item questionnaire exploring subjective cognitive problems in everyday activities.
3. Everyday functioning would be assessed by the Disability Assessment for Dementia (DAD), the validated Chinese version assesses both basic and instrumental activities of daily living along three dimensions (initiation, organization and effectiveness). Earlier studies conducted in Hong Kong suggested that the initiation and organization aspects of IADL may be affected in Chinese elders with MCI.
4. Motivational symptoms were assessed by the Cornell Scale for depression in dementia (CSDD) and the Neuropsychiatric Inventory (NPI).

No

2012-06-28

ChiCTR-TRC-11001359

2011-06-09


Yes

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