The transition to higher education is characterized by increased academic demands and psychosocial stress, which may negatively affect cognitive functioning and student well-being. Executive functions (working memory, inhibitory control, and cognitive flexibility) are critical for academic adaptation and can be enhanced through structured interventions. Physical exercise, mind–body practices, and cognitive training have demonstrated potential benefits for executive functioning and stress reduction; however, few randomized controlled trials have directly compared interventions with different physical and cognitive demands in university students, particularly in Latin America. In addition, most studies have relied on self-report measures and physiological stress biomarkers such as salivary cortisol.
This protocol describes a three-arm, parallel-group randomized controlled trial designed to evaluate the effects of a 12-week intervention on executive functions and stress in first-year university students. The study will recruit 160 first-year health-science students aged 18–25 years. Participants will be randomly assigned (1:1:1), using block randomization stratified by sex, to one of three interventions delivered twice weekly (24 sessions of 60 minutes): (1) moderate-to-vigorous motor–cognitive dual-task exercise (DT); (2) low-to-moderate intensity Tai Chi (TC); or (3) supervised digital cognitive training (CT) using structured graphomotor tasks.
Primary outcomes include executive functions assessed through standardized neuropsychological measures. Secondary outcomes include stress will be evaluated using the Academic Stress Inventory, Depression Anxiety Stress Scales and salivary cortisol collected in the morning using passive drool and analyzed by competitive ELISA.Other outcomes include physical activity levels, anthropometric and body composition measures, and handgrip strength. Data will be analyzed following an intention-to-treat approach using repeated-measures models, with multiple imputation for missing data.
The study has received institutional ethics and biosafety approval. Trial registration: ClinicalTrials.gov Identifier: NCT07443904 27/02/26.
Competing Interest StatementThe authors have declared no competing interest.
Clinical TrialClinicalTrials.gov Identifier: NCT07443904 27/02/26.
Clinical ProtocolsFunding StatementYes
Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
This study involves human participants. Ethical approval was obtained from the Scientific Ethics Committee of Universidad San Sebastián (Comité Científico de Ética, Universidad San Sebastián), Chile (approval number: 57-25). The study protocol was also approved by the Institutional Biosafety Committee of Universidad San Sebastián, Chile (approval number: B-25-018). Written informed consent will be obtained from all participants prior to participation. Participants will be informed about the study objectives, procedures, potential risks and benefits, and their right to withdraw at any time without consequences. All procedures will be conducted in accordance with the Declaration of Helsinki and institutional ethical guidelines for research involving human participants.
I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.
Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.
Yes
Data AvailabilityAll relevant data from this study will be made available upon study completion.
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