Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000855426
Ethics application status
Approved
Date submitted
19/05/2025
Date registered
7/08/2025
Date last updated
7/08/2025
Date data sharing statement initially provided
7/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A school-based posture education program to improve lung function, heart health, and psychological well-being in adolescents
Scientific title
Development and Effectiveness of a Posture Education Program on Cardiovascular Health, Lung Function, and Psychological Well-Being in High School Students: A Randomized Controlled Trial
Secondary ID [1] 314460 0
NIL
Universal Trial Number (UTN)
Trial acronym
PEP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Poor posture 337494 0
Condition category
Condition code
Musculoskeletal 333860 333860 0 0
Other muscular and skeletal disorders
Cardiovascular 334030 334030 0 0
Normal development and function of the cardiovascular system
Respiratory 334031 334031 0 0
Normal development and function of the respiratory system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study implements a structured Posture Education Program (PEP) aimed at improving posture, cardiovascular health, and psychological well-being among high school students.
The intervention is delivered over 14 weeks, with one face-to-face group session per week (each session lasting approximately 45–50 minutes).
Content of the Intervention:
The sessions are interactive and based on evidence-informed practices from physiotherapy, health psychology, and ergonomic guidelines. They include:
Posture awareness and ergonomics education (aligned with ICF framework and informed by the American Physical Therapy Association and WHO school health frameworks)
Stretching and strengthening exercises for postural muscles
Breathing techniques to support lung function
Mindfulness and stress-reduction strategies to support psychological well-being
Program materials were developed by the research team, validated through the Delphi method, and aligned with clinical guidelines and evidence from studies such as Alves et al. (2020), Macialczyk-Paprocka et al. (2017), and Inagaki et al. (2018).
Delivery Mode:
Face-to-face in group settings, conducted within secondary school classrooms.
Provider Expertise:
Delivered by certified physiotherapists and trained PE teachers/health educators experienced in youth health promotion and posture correction strategies.
Materials Used:
Includes posters, ergonomic toolkits, posture grids, and educational leaflets.
Materials are specifically developed for this study based on posture and health education best practices. Where adapted from existing resources.
Co-Interventions:
Students will continue attending their regular Physical Education (PE) classes as per the school curriculum. The posture program acts as an adjunct intervention and does not replace routine PE.
Fidelity Monitoring:
Attendance will be tracked using session logs.
Students will complete weekly reflection logs summarizing key learnings and behavior changes.
Facilitators will use session checklists to ensure consistency in content delivery.
Intervention code [1] 331082 0
Behaviour
Intervention code [2] 331083 0
Rehabilitation
Intervention code [3] 331084 0
Lifestyle
Comparator / control treatment
Students in the control group receive the usual school PE classes, which include general physical activity and fitness exercises such as aerobic warm-ups (e.g., jogging, jumping jacks), strength exercises (e.g., push-ups, sit-ups), flexibility routines (e.g., basic stretching), and team sports (e.g., basketball, football).
These sessions do not include any posture education or corrective posture-focused content.
PE classes are conducted twice per week, with each session lasting approximately 45–60 minutes.
Control group
Active

Outcomes
Primary outcome [1] 341486 0
Peak Expiratory Flow Rate (PEFR)
Timepoint [1] 341486 0
Baseline and Week 14 (post-intervention)
Primary outcome [2] 341487 0
Composite outcome: resting heart rate and blood pressure
Timepoint [2] 341487 0
Baseline and Week 14 (post-intervention)
Primary outcome [3] 341488 0
Composite outcome: Quality of life and psychological well-being
Timepoint [3] 341488 0
Baseline and Week 14 (post-intervention)
Secondary outcome [1] 447730 0
Aerobic capacity
Timepoint [1] 447730 0
Baseline and Week 14 (post-intervention)
Secondary outcome [2] 447731 0
Vital capacity (VC)
Timepoint [2] 447731 0
Baseline and Week 14 (post-intervention)

Eligibility
Key inclusion criteria
High school students aged 14 to 17 years
Enrolled in grades 9–11 in participating schools
Able to understand instructions in English
Physically able to participate in school physical activity and testing procedures
Provide informed assent, with parental/guardian consent obtained
Minimum age
14 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Diagnosed cardiovascular, pulmonary, or musculoskeletal disorders
Existing psychological or neurodevelopmental conditions that interfere with participation
History of recent surgery or injury preventing physical activity
Currently involved in any other clinical trial

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the holder of the allocation schedule who was “off-site” or at central administration site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computer-generated random number table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/08/2025
Actual
Date of last participant enrolment
Anticipated
15/09/2025
Actual
Date of last data collection
Anticipated
30/11/2025
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment outside Australia
Country [1] 27072 0
United Arab Emirates
State/province [1] 27072 0
Al Ain, Abu Dhabi

Funding & Sponsors
Funding source category [1] 318998 0
Self funded/Unfunded
Name [1] 318998 0
Jeyanthi Valaitham– Universiti Kebangsaan Malaysia
Country [1] 318998 0
United Arab Emirates
Primary sponsor type
University
Name
Universiti Kebangsaan Malaysia (UKM)
Address
Country
Malaysia
Secondary sponsor category [1] 321463 0
None
Name [1] 321463 0
Address [1] 321463 0
Country [1] 321463 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317611 0
Research Ethics Committee – Universiti Kebangsaan Malaysia (UKM)
Ethics committee address [1] 317611 0
Ethics committee country [1] 317611 0
Malaysia
Date submitted for ethics approval [1] 317611 0
07/02/2025
Approval date [1] 317611 0
18/06/2025
Ethics approval number [1] 317611 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141558 0
Ms Jeyanthi Valaitham
Address 141558 0
Faculty of Health Sciences, Fakulti Sains Kesihatan, Universiti Kebangsaan Malaysia Jalan Raja Muda Abdul Aziz 50300 Kuala Lumpur Universiti Kebangsaan Malaysia
Country 141558 0
Malaysia
Phone 141558 0
+971509627208
Fax 141558 0
Email 141558 0
[email protected]
Contact person for public queries
Name 141559 0
Jeyanthi Valaitham
Address 141559 0
Faculty of Health SciencesFakulti Sains Kesihatan, Universiti Kebangsaan Malaysia Jalan Raja Muda Abdul Aziz 50300 Kuala Lumpur , Universiti Kebangsaan Malaysia
Country 141559 0
Malaysia
Phone 141559 0
+971509627208
Fax 141559 0
Email 141559 0
[email protected]
Contact person for scientific queries
Name 141560 0
Dr. Asfarina Zanudin
Address 141560 0
Center for Rehabilitation and Special Needs, UKM Medical Centre Fakulti Sains Kesihatan, Universiti Kebangsaan Malaysia Jalan Raja Muda Abdul Aziz 50300 Kuala Lumpur
Country 141560 0
Malaysia
Phone 141560 0
+60 11 2817 7381
Fax 141560 0
Email 141560 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: The study involves school-aged minors and includes sensitive psychological and health-related data. To protect participant confidentiality and comply with ethical requirements from Universiti Kebangsaan Malaysia, individual-level data will not be made publicly available



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.