Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00521

2 Trial Registration Date

2016-08-18

i Registration Status

Prospective

3 Secondary IDs

not applicable

4 Source(s) of Funding

Association of Hong Kong Nursing Staff

5 Primary Sponsor

No sponsor

6 Secondary Sponsor

No sponsor

Function

Not Applicable

Please specify

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

i Name

Chan Leong Tat

ii Address

7/F, Esther Lee Building, Chung Chi College, the Chinese Univerisity of Hong Kong

iii Phone

60953710

iv Email

1006696971@link.cuhk.edu.hk

v Affiliation

The Nethersole School of Nursing

vi Country

Hong Kong

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

i Name

Leong Tat Chan

ii Address

Rm. 2611, Sun Wai House, Sun Chui Estate, Shatin, N. T.

iii Phone

60953710

iv Email

1006696971@link.cuhk.edu.hk

v Affiliation

The Nethersole School of Nursing, The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

Effect of a structured aerobic exercise programme in managing fatigue among community dwelling older adults with multicomorbidities by a prospective randomized controlled trial

10 Public Title

Effect of a structured aerobic exercise programme in managing fatigue among community dwelling older adults with multicomorbidities

i Public Title in Chinese 研究名稱

探討有效改善社區中共病長者疲憊的方法

11 Short Title (Optional)

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?

2016-01-29

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2015.512

14 Medical Condition Being Studied

multicomorbidities

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Structured aerobic exercise

iii Dosage form of the intervention

aerobic exercise

iv Dosage of the intervention

moderate intensity as determined by Borg scale of Perceived Exertion

v Duration of the intervention

12 weeks

vi Frequency of the intervention

3 times per week

16 Comparative Treatments

i Description/ name of comparative treatments

health talks

ii Dosage form of the comparative treatments

health talks

iii Dosage of the comparative treatments

1 hour per each session, total 6 sessions

iv Duration of the comparative treatments

12 weeks

v Frequency of the comparative treatments

once per two weeks

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Chinese

aged 60 or above

able to communicate

Abbreviated Mental Test score equal or greater than 6

score of reduced activity subscale of Multidimensional Fatigue Inventory >=10

ii Exclusion Criteria

visually imparied

auditory imparied

inability to walk

have pre-existing psychiatric diagnosis

bedbound

musculoskeletal contracture

acute exacerbation of osteoarthritis

received cancer treatments in the past 24 months

have advanced or terminal malignancies as being labelled as supportive or terminal care by qualified physicians

received operation in the past 6 months

participate in other structured exercise programme

iii Age Minimum

60

iv Age Maximum

not applicable

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

blocked randomization

ii Nature of control

Placebo

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Trial subjects

iv Group Assignment

Parallel

v Study Phase

3

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2016-09-01

21 Target Sample Size

140

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

fatigue

ii The metric or method of measurement used

Multidimensional Fatigue Inventory

iii The timepoint(s) of primary interest

pre-intervention, post-intervention, 3 months after intervention

24 Secondary Outcome

i The Name of the outcome

mood status

ii The metric or method of measurement used

Profile of Mood States short form - Chinese version

iii The timepoint(s) of primary interest

pre-intervention, post-intervention, 3 months after intervention

Secondary Outcome

i The Name of the outcome

exercise tolerance capacity

ii The metric or method of measurement used

2-minute walk test, Chinese version of International Physical Activity Questionnaire- short form

iii The timepoint(s) of primary interest

pre-intervention, post-intervention, 3 months after intervention

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2018-09-15

27 Primary Registry and Trial Identifying Number

ChiCTR-IIR-16009056

28 Date of Registration in Primary Registry

2016-08-18

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Trial History Detail on 2018-09-15