Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000623493p
Ethics application status
Submitted, not yet approved
Date submitted
28/04/2025
Date registered
13/06/2025
Date last updated
13/06/2025
Date data sharing statement initially provided
13/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Including Healthy Breaks During Theoretical Classes in Higher Education
Scientific title
Effect of Including Healthy Breaks on musculoskeletal discomfort During Theoretical Classes in Higher Education: A Controlled Experimental Study with a Mixed Quantitative and Qualitative Component in Spanish Universities
Secondary ID [1] 314202 0
None
Universal Trial Number (UTN)
Trial acronym
MSC-Breaks.
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cognitive fatigue 337638 0
physical inactivity 337099 0
low mood 337639 0
Sedentary behaviour 337098 0
musculoskeletal discomfort 337100 0
Condition category
Condition code
Musculoskeletal 333516 333516 0 0
Other muscular and skeletal disorders
Mental Health 333517 333517 0 0
Other mental health disorders
Public Health 333515 333515 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Delivered face-to-face by the instructor during class.
Frequency: 2–3 sessions/week for 8 weeks.
20-30 students per class.
Theorical lessons will have between 90 and 120 minutes.
Break time at the middle after class starts,
All students will be invite to participate during lessons.
Fidelity to intervention will be considered thorough attendance log.


Arm 1 – High-intensity physical activity break:
Participants perform a 4–5-minute structured cardiovascular routine during a scheduled break in class. Exercises include jumping jacks, high knees, squats, etc.


Arm 2 – Stretching break:
Participants follow a 4–5-minute guided stretching session targeting major muscle groups (neck, back, legs). Conducted by the instructor in class. Frequency: 2–3 sessions/week for 8 weeks.

Arm 3 – Educational video:
Participants watch a 4–5-minute video on healthy lifestyle habits, covering topics such as sedentarism and benefits of physical activity. Delivered via screen in class, same schedule as other arms.

Arm 4 – Passive break (active control):
Participants are given a 4–5-minute break but are free to use the time as they wish (e.g., rest, check phone), with no structured content. Delivered in class, 2–3 sessions/week for 8 weeks.

Additionally, a qualitative component will be conducted using semi-structured interviews to explore participants' perceptions and experiences regarding the active breaks interventions.
Intervention code [1] 330805 0
Lifestyle
Intervention code [2] 330806 0
Behaviour
Comparator / control treatment
Control groups include:
- Arm 5: No break – students attend class without any scheduled break.
Control group
Active

Outcomes
Primary outcome [1] 341616 0
Pain perceived
Timepoint [1] 341616 0
Baseline (Week 0) and immediately post-intervention (Week 8) – Week 8 is the primary timepoint
Primary outcome [2] 341089 0
Musculoskeletal discomfort
Timepoint [2] 341089 0
Baseline (Week 0) and immediately post-intervention (Week 8) – Week 8 is the primary timepoint
Primary outcome [3] 341090 0
Affective response to task
Timepoint [3] 341090 0
Immediately before and after each break; summary analysis will focus on Week 4 and Week 8 (Week 8 is the primary timepoint)
Secondary outcome [1] 446201 0
Sedentary behaviour
Timepoint [1] 446201 0
Baseline (Week 0) and post-intervention (Week 8)
Secondary outcome [2] 446200 0
Physical activity level
Timepoint [2] 446200 0
Baseline (Week 0) and post-intervention (Week 8)
Secondary outcome [3] 446205 0
Mood
Timepoint [3] 446205 0
Baseline and post-intervention (Week 8)
Secondary outcome [4] 446203 0
Internal training load
Timepoint [4] 446203 0
During each break session; weekly averages analyzed at Week 4 and Week 8 post-intervention commencement
Secondary outcome [5] 446202 0
Cognitive function
Timepoint [5] 446202 0
Baseline and after the intervention period (Week 8)
Secondary outcome [6] 446902 0
Perceptions and experiences regarding active breaks.
Timepoint [6] 446902 0
After 8-week intervention period.
Secondary outcome [7] 446204 0
Academic performance
Timepoint [7] 446204 0
End of semester (within 4 weeks post-intervention completion)
Secondary outcome [8] 448085 0
Exertion effort
Timepoint [8] 448085 0
During each break session; weekly averages analyzed at Week 4 and Week 8

Eligibility
Key inclusion criteria
University students enrolled in participating courses.
Aged 18 years or older.
Able and willing to participate in physical activity during class.
Able to provide informed consent.
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Medical contraindications to physical activity (e.g., cardiovascular conditions, musculoskeletal injuries).
Current injury or condition that may be aggravated by participation.
Inability to attend a minimum of 70% of sessions.
Cognitive impairment that would prevent understanding or completing study questionnaires.

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 will be concealed using sealed, opaque envelopes prepared in advance by a researcher not involved in participant recruitment or data collection. Instructors and participants will be unaware of the group allocation until the moment of the intervention assignment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be generated using computer-based software (e.g., R or SPSS) to assign instructors/classes to one of five intervention arms. A simple randomisation method without replacement will be used. Stratification by faculty or course will not be applied.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Mixed-methods study with quantitative and qualitative components. The qualitative component will use semi-structured interviews analyzed through thematic content analysis to complement quantitative outcomes.

Between-group comparisons will be conducted using ANOVA or ANCOVA depending on the outcome variable, controlling for baseline values where appropriate. Post-hoc analyses will be applied with Bonferroni correction. For within-group changes, paired t-tests or Wilcoxon signed-rank tests will be used. Effect sizes will be calculated using Cohen's d or partial eta squared. Statistical significance will be set at p < 0.05. Quantitative analyses will be performed using Jamovi version 2.3.18. Qualitative data from interviews will be analyzed thematically following content analysis principles.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2025
Actual
Date of last participant enrolment
Anticipated
30/11/2025
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment outside Australia
Country [1] 26975 0
Spain
State/province [1] 26975 0
Sevilla

Funding & Sponsors
Funding source category [1] 318719 0
University
Name [1] 318719 0
Universidad de Sevilla
Country [1] 318719 0
Spain
Primary sponsor type
University
Name
Universidad de Sevilla
Address
Country
Spain
Secondary sponsor category [1] 321152 0
University
Name [1] 321152 0
Universidad de Córdoba
Address [1] 321152 0
Country [1] 321152 0
Spain
Secondary sponsor category [2] 321154 0
University
Name [2] 321154 0
Tecnocampus Mataró (Universitat Pompeu Fabra)
Address [2] 321154 0
Country [2] 321154 0
Spain
Secondary sponsor category [3] 321153 0
University
Name [3] 321153 0
Fundación CEU San Pablo
Address [3] 321153 0
Country [3] 321153 0
Spain

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317330 0
Universidad de Sevilla
Ethics committee address [1] 317330 0
Ethics committee country [1] 317330 0
Spain
Date submitted for ethics approval [1] 317330 0
20/05/2025
Approval date [1] 317330 0
Ethics approval number [1] 317330 0

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

Contacts
Principal investigator
Name 140706 0
Dr Borja Sañudo Corrales
Address 140706 0
Universidad de Sevilla, Facultad de Ciencias de la Educación, C/ Pirotecnia s/n, 41013 Sevilla
Country 140706 0
Spain
Phone 140706 0
+34 954557800
Fax 140706 0
Email 140706 0
[email protected]
Contact person for public queries
Name 140707 0
Borja Sañudo Corrales
Address 140707 0
Universidad de Sevilla, Facultad de Ciencias de la Educación, C/ Pirotecnia s/n, 41013 Sevilla
Country 140707 0
Spain
Phone 140707 0
+34 954557800
Fax 140707 0
Email 140707 0
[email protected]
Contact person for scientific queries
Name 140708 0
Borja Sañudo Corrales
Address 140708 0
Universidad de Sevilla, Facultad de Ciencias de la Educación, C/ Pirotecnia s/n, 41013 Sevilla
Country 140708 0
Spain
Phone 140708 0
+34 954557800
Fax 140708 0
Email 140708 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Studies testing whether findings can be repeated or confirmed
• Teaching research methods or developing new statistical techniques
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
Yes: Access to data will require a formal request, including a study proposal and proof of ethics approval. A data use agreement will be required to ensure responsible use of the dataset and compliance with GDPR and institutional policies.



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.