CCRB Logo

Trial Detail

CUHK_CCT00445

2015-02-03

Prospective

2014.566

Health and Medical Research Fund

Department of Psychiatry, The Chinese University of Hong Kong

N/A

Ms Harriet W Y Tang 鄧穎瑜

Room 3A, Block E, Staff Quarters, Prince of Wales Hospital, 46 Ngan Shing Street, Shatin

852-28314305

harriet@cuhk.edu.hk

Department of Psychiatry, The Chinese University of Hong Kong

Prof. Linda CW Lam 林翠華

Department of Psychiatry, G/F Multi-Centre, Tai Po Hospital, Tai Po. NT, Hong Kong

852-26076027

cwlam@cuhk.edu.hk

Department of Psychiatry, the Chinese University of Hong Kong

A randomized controlled trial of combined physical exercise-working memory training on slowing down cognitive decline in elders with mild clinical Alzheimer’s disease

A randomized controlled trial of combined physical exercise-working memory training on slowing down cognitive decline in elders with mild clinical Alzheimer’s disease

運動訓練與工作記憶訓練對減慢輕度阿氏痴呆症長者認知能力下降之隨機對比研究

A randomized controlled trial of combined physical exercise-working memory training on slowing down cognitive decline in elders with mild clinical Alzheimer’s disease

Hong Kong SAR, China

Yes

2014-12-18

Mild clinical Alzheimer’s disease

Behavior

Physical exercise and Working memory training

6 weeks intervention

6 week intervention of either physical exercise (PE) training, working memory (WM) training, combined PE-WM training, or caregiver education (control)

1. Subjects from 60 to 90 years old;
2. DSM-5 diagnosis of Major Neurocognitive Disorder due to AD (22), which would satisfy the criteria for significant cognitive decline in at least one of six areas of cognition (memory, perceptual-motor, complex attention, language, executive function and social cognition) and functional disturbance, with clinical or biological features indicative of AD;
3. CDR of 1 indicating mild dementia; and
4. Ambulatory with low risk of fall as assessed by the physiotherapist (co-A)

1. Past history of bipolar affective disorder or psychosis;
2 Physical frailty affecting attendance to training sessions;
3. Already attending regular cognitive training;
4. History of major neurological deficit including history of stroke, or traumatic brain injury; and
5. Significant communicative impairments.

60

90

Both Male and Female

Interventional

Randomized

Active

Single-blind

Parallel

2015-02-14

376

Unknown

Global cognitive function would be measured by the Chinese version of the
Alzheimer’s Disease Assessment Scale – Cognitive Subscale (ADAS-Cog) (25). Itis a standard global cognitive assessment for clinical intervention of AD.CMMSE scores would also be recorded as a measure of global cognition. Assesment and records of adverse events will be conducted at baseline, 6th week and 12th weeks.

Clinical Dementia Rating (CDR) is a semi-structured clinical interview for the severity of cognitive impairment rated along six dimensions of cognition and function (memory, orientation, judgment & problem solving, community affairs,home, hobbies and personal care. Scores in each dimension are combined to forma global rating ranging from 0 (not demented), 0.5 (very mild), 1 (mild), 2(moderate) to 3 (severe dementia). (20).

Working memory test – the n-back task performance at baseline, 6th and 12th weeks would be recorded as a direct measure of improvement in task
performance.

Memory and language tests – logical memory, 10 minutes list learning delay recall,
category verbal fluency and trail making tests would be evaluated to examine the effects of both PE and WM training on other cognitive abilities.

The Chinese Neuropsychiatric Inventory (NPI) would be used to assess changes in neuropsychiatric symptoms across 12 different domains. In the current proposal, NPI would evaluate potential mood and behavioral changes.

The Disability Assessment for Dementia (DAD) assesses functional abilities in
both basic and instrumental activities of daily living.

Revised Borg Scale to measure subjective sense of exertion.

Quality of Life –AD. It is a 13 item instrument adopted as a generic measure for the quality of life in patients with Alzheimer’s disease.

Leisure activity participation – in order to measure behavioral change after participation of the study..

Assesment and records of adverse events will be conducted at baseline, 6th week and 12th weeks.

No

2016-03-04

ChiCTR-IOR-15005942

2015-02-05

Type Document Published On  
No documents yet.
  • Page 1 of 1.