Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00555

2 Trial Registration Date

2017-05-04

i Registration Status

Prospective

3 Secondary IDs

CREC IRB no.: 2017.139-T

4 Source(s) of Funding

NA

5 Primary Sponsor

Au Yeung Elce

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Au Yeung Elce

ii Address

School of Midwifery,
Prince of Wales Hospital,
Shatin,
Hong Kong

iii Phone

35053713

iv Email

ae483@ha.org.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

Elce Au Yeung

ii Address

School of Midwifery,
Prince of Wales Hospital,
Shatin,
Hong Kong

iii Phone

35053713

iv Email

kenelce@netvigator.com

v Affiliation

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

vi Country

Hong Kong

9 Official Scientific Title of the Study

A randomized controlled trial to evaluate the effectiveness of an ehealth antenatal exercise intervention in improving lumbopelvic pain in Hong Kong chinese pregnant women

10 Public Title

A randomized controlled trial to evaluate the effectiveness of an ehealth antenatal exercise intervention in improving lumbopelvic pain in Hong Kong chinese pregnant women

i Public Title in Chinese 研究名稱

隨機對照研究調查產前運動教育干預對改善懷孕婦女腰背痛之效果

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?

2017-03-29

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2017.139_T

14 Medical Condition Being Studied

lumbopelvic pain

15 Intervention

i Types of intervention

Behavior

Please specify

ii Description/ name of Intervention/article

usual antenatal care and antenatal exercise intervention

iii Dosage form of the intervention

smartphone apps, information booklet, counseling, telephone boosters at 4th and 8th week of recruitment

iv Dosage of the intervention

Counseling at recruitment, information booklet and apps provide readily available information

v Duration of the intervention

12 weeks

vi Frequency of the intervention

Aiming at achieving 150 minutes of antenatal exercise per week

16 Comparative Treatments

i Description/ name of comparative treatments

Usual antenatal care

ii Dosage form of the comparative treatments

information leaflet and counseiling; telephone booster at 4th and 8th weeks of recruitment

iii Dosage of the comparative treatments

once

iv Duration of the comparative treatments

12 weeks

v Frequency of the comparative treatments

NA

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

healthy Hong Kong Chinese pregnant women

aged 18–45

from 13th to 24th weeks’ gestation

who can read, write, and speak Chinese

who possess a smartphone

ii Exclusion Criteria

contraindication against performing antenatal exercise as listed by the American College of Obstetricians and Gynecologist (2015)

any current or past history of psychiatric disease

refusal to participate in the study

iii Age Minimum

18

iv Age Maximum

45

v Gender

Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Block randomization

ii Nature of control

Active

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Trial subjects

iv Group Assignment

Parallel

v Study Phase

0

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2017-05-15

21 Target Sample Size

134

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

the prevalence of LPP

ii The metric or method of measurement used

A numeric pain rating scale (NPRS)

iii The timepoint(s) of primary interest

at recruitment and 12th week

Primary Outcome

i The Name of the outcome

functional disability of LPP

ii The metric or method of measurement used

Hong Kong version of Roland Morris Disability Questionnaire

iii The timepoint(s) of primary interest

at recruitment and 12th week

24 Secondary Outcome

i The Name of the outcome

physical activity level

ii The metric or method of measurement used

Chinese version of Pregnancy Physical Activity Questionnaire

iii The timepoint(s) of primary interest

at recruitment and 12th week

Secondary Outcome

i The Name of the outcome

risk of antenatal depression

ii The metric or method of measurement used

Chinese version of Edinburgh Postnatal Depression Scale (EPDS)

iii The timepoint(s) of primary interest

at recruitment and 12th week

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2017-07-03

27 Primary Registry and Trial Identifying Number

ChiCTR-INR-17011308

28 Date of Registration in Primary Registry

2017-05-04

Back History

Trial Detail