Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00448

2 Trial Registration Date

2015-03-20

i Registration Status

Prospective

3 Secondary IDs

2014.485-T

4 Source(s) of Funding

Departmental research theme group fund

5 Primary Sponsor

The Nethersole School of Nursing

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Aileen Chan

ii Address

7/F., Esther Lee Building, the Nthersole School of Nursing, CUHK

iii Phone

39434290

iv Email

aileenchan@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

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

i Name

Aileen Chan

ii Address

7/F., Esther Lee Building, the Nthersole School of Nursing, CUHK

iii Phone

39434290

iv Email

aileenchan@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

Tai chi qigong exercise as an intervention to improve cognitive and behavioral symptoms and enhance nighttime sleep among older adults with cognitive impairment

10 Public Title

tai chi qigong enhance sleep and cognitive functions

i Public Title in Chinese 研究名稱

太極氣功運動改善認知障礙者的認知和行為症狀及提升睡眠質素

11 Short Title (Optional)

Tai chi qigong enhance sleep and cognitive functions

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2014-11-11

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2014.485-T

14 Medical Condition Being Studied

Older adults with cognitive impairment (MMSE score 13-26)

15 Intervention

i Types of intervention

Other

Please specify

Tai chi qigong

ii Description/ name of Intervention/article

10 forms of tai chi qigong exercise

iii Dosage form of the intervention

Tai chi qigong training

iv Dosage of the intervention

60-minute sessions, twice a week

v Duration of the intervention

Two months

vi Frequency of the intervention

Twice a week for 2 months, self practice for 30 minutes daily

16 Comparative Treatments

i Description/ name of comparative treatments

The tai chi qigong group will receive a tai chi qigong training, which consists of two 60-minute sessions each week for 2 months, and self-practice at home for 30 minutes every day. The control group will be advised to maintain their usual activities.

ii Dosage form of the comparative treatments

health talks

iii Dosage of the comparative treatments

60 minutes

iv Duration of the comparative treatments

2 months

v Frequency of the comparative treatments

Once a week

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

1. Aged 60 years or above
2. With cognitive impairment (with MMSE: 13 to 26)
3. Suffer from sleep disturbances (CPSQI>5)

ii Exclusion Criteria

1. Have severe impaired ambulation or musculoskeletal problems that limit their tai chi qigong practice
2. are receiving treatment for their sleep disorder
3. have engaged in tai chi qigong practice during the past six months

iii Age Minimum

60

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

By computer generated randomo numbers

ii Nature of control

Placebo

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Investigator/research team

iv Group Assignment

Parallel

v Study Phase

0

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2015-04-20

21 Target Sample Size

60

22 Recruitment Status

Complete

23 Primary Outcome

Sleep quality

measured at baseline,3 months and 6 months

24 Secondary Outcome

1. An objective measure of sleep pattern using sleep tracker
2. (ii) Mini Mental State Examination (MMSE) questionnaire
3. (iii) Memory Inventory for Chinese (MIC) questionnaire
4. Short-Form 12 Health Survey (SF-12v2 Health Survey)

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2017-05-01

27 Primary Registry and Trial Identifying Number

ChiCTR-IOR-15006128

28 Date of Registration in Primary Registry

2015-03-22

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Trial History Detail on 2016-02-17