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CTRI Number  CTRI/2022/03/040973 [Registered on: 10/03/2022] Trial Registered Prospectively
Last Modified On: 09/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA)
Behavioral 
Study Design  Cluster Randomized Trial 
Public Title of Study   Effectiveness Of Antenatal Exercise Intervention on Exercise Adherence Among Pregnant Women 
Scientific Title of Study   Effectiveness Of Antenatal Exercise Intervention Using Behavioral Theory On Exercise Adherence Among Antenatal Women In Kuala Selangor District 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rosliza Abdul Manaf 
Designation  Associate Professor 
Affiliation  Universiti Putra Malaysia 
Address  Department of Community Health Faculty of Medicine Health Sciences Universiti Putra Malaysia



43400
Other 
Phone    
Fax    
Email  rosliza_abmanaf@upm.edu.my  
 
Details of Contact Person
Scientific Query  
Name  Rosliza Abdul Manaf 
Designation  Associate Professor 
Affiliation  Universiti Putra Malaysia 
Address  Department of Community Health Faculty of Medicine Health Sciences Universiti Putra Malaysia



43400
Other 
Phone    
Fax    
Email  rosliza_abmanaf@upm.edu.my  
 
Details of Contact Person
Public Query  
Name  NUR FARHANA MD YUNUS 
Designation  PhD student 
Affiliation  Universiti Putra Malaysia 
Address  Department of Community Health Faculty of Medicine Health Sciences Universiti Putra Malaysia



43400
Other 
Phone  0123915516  
Fax    
Email  gs58667@student.upm.edu.my  
 
Source of Monetary or Material Support  
Primary Healthcare Clinics Kuala Selangor District Malaysia 
 
Primary Sponsor  
Name  Rosliza Abdul Manaf 
Address  Department of Community Health Faculty of Medicine Health Sciences Universiti Putra Malaysia 43400 Serdang Selangor Malaysia 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Malaysia  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Nur Farhana Md Yunus  Bestari Jaya Health Clinic  1867 Jln Kampung Pekan Batang Berjuntai 45600 Batang Berjuntai Selangor Malaysia

 		 60123915516

gs58667@student.upm.edu.my 
Nur Farhana Md Yunus  Bukit Cherakah Health Clinic  Jln Rizab Masjid Kampung Bukit Cherakah 45800 Jeram Selangor Malaysia

 		 60123915516

gs58667@student.upm.edu.my 
Nur Farhana Md Yunus  Ijok Health Clinic  JKR 1087 Jln 14 Ijok 45700 Batang Berjuntai Selangor Malaysia

 		 60123915516

gs58667@student.upm.edu.my 
Nur Farhana Md Yunus  Jeram Health Clinic  Jalan Klang 45800 Jeram Kuala Selangor Malaysia

 		 60123915516

gs58667@student.upm.edu.my 
Nur Farhana Md Yunus  Kuala Selangor Health Clinic  Jalan Klinik Bandar Malawati 45000 Kuala Selangor Selangor Malaysia

 		 60123915516

gs58667@student.upm.edu.my 
Nur Farhana Md Yunus  Tanjung Karang Health Clinic  Jalan Sungai Kajang Lama Sungai Kajang 45500 Tanjong Karang Selangor Malaysia

 		 60123915516

gs58667@student.upm.edu.my 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Medical Research and Ethics Committee Malaysia  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O269||Pregnancy related conditions, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Antenatal exercise intervention group  The intervention group will receive 12 weeks antenatal exercise module integrated with IMB model construct (information, motivation and behavioural skills). The module will be delivered using video-based approach through telegram group in six session, every 2 weeks. The module consists of short lecture video, attractive antenatal exercise video, role play video, short messaging and multimedia messaging service (MMS) technology. 
Comparator Agent  Control group  The control groups in this study will receive standard antenatal care only 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Antenatal women:
- at 12-16 weeks of gestation.
- who did not actively exercise or attend any antenatal exercise class during current pregnancy.
- who owned smart mobile phone.
- who able to read and understand the Malay language.
- who will continue their check-up in the same clinic during their pregnancy.

 
 
ExclusionCriteria 
Details  - Antenatal women who presented and/or diagnosed with medical or obstetric complications (heart problem, thyroid disease, multiple pregnancies, high blood pressure, diabetes, anaemia, asthma, epilepsy, and cervical incompetence) and serious psychological conditions that could have impacted the reliability of information.
- High risk pregnancy (contraindications to exercise e.g. placenta previa, persistent bleeding, cervical incompetence).
- Non singleton pregnancy
- High risk for preterm delivery (birth before 37 weeks) such as twin pregnancy.

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine the effectiveness of ANE intervention module on exercise adherence among antenatal women in primary health care.  baseline, immediately post intervention and 1 month post intervention 
 
Secondary Outcome  
Outcome  TimePoints 
-To determine the effectiveness of ANE intervention module on information, motivation and behavioural skills (perceived benefits, perceived barriers and exercise self-efficacy)
-To determine the effectiveness of ANE intervention module on HRQOL  		 baseline, immediately post intervention and 1 month post intervention 
 
Target Sample Size   Total Sample Size="322"
Sample Size from India="0" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  09/05/2022 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Applicable 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This study is a cluster randomized, single blind, parallel group to determine the effectiveness of antenatal exercise module intervention using behavioral theory on exercise adherence among 322 antenatal women in six primary health care clinics in Selangor, Malaysia. The primary outcome measures will be a significant differences on exercise adherence at immediately post intervention and 1 month post intervention between intervention and control group. The secondary outcomes will be a significant differences on information, motivation, behavioral skills and HRQOL at immediately post intervention and 1 month post intervention between intervention and control group. 
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