Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-29 @ 11:59 PM
Study NCT ID:
NCT07443904
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Muévete conCiencia: Exercise and Mind-Body Program for First-Year University Students
Sponsor:
Universidad San Sebastián
Organization:
Study Overview
Official Title:
Muévete conCiencia Project: Protocol for a Randomized Controlled Trial of Physical Exercise and Mind-Body Interventions in University Students
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to evaluate whether different physical exercise and mind-body interventions can improve executive functions and reduce stress in first-year university students.
The study focuses on healthy undergraduate students, men and women, aged approximately 18-25 years, enrolled in the first year of health-related programs at a Chilean university.
The main questions it aims to answer are:
Do high-intensity dual-task physical exercise interventions improve executive functions (working memory, inhibitory control, and cognitive flexibility) and reduce stress in university students? Do mind-body exercise interventions (Tai Chi) reduce stress levels, measured through self-report and psychobiological biomarkers (cortisol)? Are there differential effects between high-intensity dual-task exercise, low-to-moderate intensity mind-body exercise, and cognitive stimulation on executive functioning and stress-related outcomes?
Researchers will compare:
* high-intensity dual-task exercise group,
* low-to-moderate intensity mind-body exercise group (Tai Chi), and
* cognitive stimulation control group,
To determine whether physically integrated motor-cognitive training produces greater improvements in executive functions and stress biomarkers than mind-body exercise or cognitive stimulation alone.
Participants will:
Complete baseline pre-intervention and post-intervention assessments, Neuropsychological tests of executive functions (working memory, inhibitory control, cognitive flexibility), Self-reported academic stress questionnaires, Psychobiological measures of stress (hair cortisol, salivary cortisol), Physical activity, anthropometric, and sociodemographic assessments.
Participate for 12 weeks (22 sessions, twice per week) in one of the following interventions:
High-intensity dual-task physical exercise, combining aerobic, strength, and motor-cognitive tasks; Low-to-moderate intensity mind-body exercise (Tai Chi) emphasizing mindful movement, balance, breathing, and attentional control; Cognitive stimulation sessions using a structured digital cognitive training program.
All sessions will be conducted in supervised, controlled settings by trained professionals, following standardized protocols to ensure safety, consistency, and adherence.
The study focuses on healthy undergraduate students, men and women, aged approximately 18-25 years, enrolled in the first year of health-related programs at a Chilean university.
The main questions it aims to answer are:
Do high-intensity dual-task physical exercise interventions improve executive functions (working memory, inhibitory control, and cognitive flexibility) and reduce stress in university students? Do mind-body exercise interventions (Tai Chi) reduce stress levels, measured through self-report and psychobiological biomarkers (cortisol)? Are there differential effects between high-intensity dual-task exercise, low-to-moderate intensity mind-body exercise, and cognitive stimulation on executive functioning and stress-related outcomes?
Researchers will compare:
* high-intensity dual-task exercise group,
* low-to-moderate intensity mind-body exercise group (Tai Chi), and
* cognitive stimulation control group,
To determine whether physically integrated motor-cognitive training produces greater improvements in executive functions and stress biomarkers than mind-body exercise or cognitive stimulation alone.
Participants will:
Complete baseline pre-intervention and post-intervention assessments, Neuropsychological tests of executive functions (working memory, inhibitory control, cognitive flexibility), Self-reported academic stress questionnaires, Psychobiological measures of stress (hair cortisol, salivary cortisol), Physical activity, anthropometric, and sociodemographic assessments.
Participate for 12 weeks (22 sessions, twice per week) in one of the following interventions:
High-intensity dual-task physical exercise, combining aerobic, strength, and motor-cognitive tasks; Low-to-moderate intensity mind-body exercise (Tai Chi) emphasizing mindful movement, balance, breathing, and attentional control; Cognitive stimulation sessions using a structured digital cognitive training program.
All sessions will be conducted in supervised, controlled settings by trained professionals, following standardized protocols to ensure safety, consistency, and adherence.
Detailed Description:
Muévete conCiencia is a single-center, three-arm, parallel-group randomized controlled trial designed to evaluate and compare the effects of three structured programs-(1) moderate-to-vigorous intensity motor-cognitive dual-task exercise, (2) low-to-moderate intensity Tai Chi as a mind-body intervention, and (3) supervised digital cognitive stimulation-on executive functioning and stress-related outcomes in first-year university students.
Rationale and background Transitioning into higher education is a developmental period characterized by increased academic demands, changes in routines, and new social and environmental stressors. Elevated and persistent stress during this stage has been associated with poorer well-being and may negatively impact cognitive performance, particularly executive functions (EF). EF-including working memory, inhibitory control, and cognitive flexibility-are higher-order cognitive processes crucial for academic performance, self-regulated learning, and problem solving. Because EF continue developing into early adulthood, the university context provides an opportunity for preventive and promotive interventions aimed at strengthening cognitive resources that support academic adaptation.
Physical activity has been associated with cognitive and mental-health benefits in university populations, including improvements in attention and EF and reductions in stress-related symptoms. Evidence indicates that cognitive outcomes may depend not only on exercise intensity but also on the cognitive demands embedded in the activity. Motor-cognitive dual-task training explicitly combines physical and cognitive loads (e.g., working memory, inhibitory control, and set shifting) and may produce larger EF gains than exercise alone by increasing executive control requirements during movement. In parallel, mind-body practices such as Tai Chi integrate mindful attention, controlled breathing, and coordinated movement and have been linked to improved psychological well-being and stress regulation. A third approach, digital cognitive stimulation, uses structured adaptive tasks to target executive components directly and can be delivered in a scalable and standardized format. However, there is limited experimental evidence comparing these modalities head-to-head within the same randomized design, particularly in Latin American university settings.
Stress is assessed using both self-report and a physiological biomarker. Cortisol is a key end-product of hypothalamic-pituitary-adrenal (HPA) axis activity and exhibits a circadian rhythm, making it a relevant biomarker for stress-related physiological regulation. Salivary sampling provides a non-invasive approach suitable for educational settings. Integrating psychological and physiological measures can contribute to a more comprehensive understanding of intervention effects and potential mechanisms.
Design and setting The study uses a three-arm randomized controlled design with pre-intervention (baseline) and post-intervention assessments. The trial is conducted at Universidad San Sebastián (Concepción campus, Chile) and targets first-year students from health-related academic programs. Participants are recruited during the university induction period and enrolled after completing baseline assessments. Given the nature of behavioral interventions, participants and instructors are not blinded; however, outcome assessors are trained and remain blinded to group allocation, and procedures are standardized to reduce performance and measurement bias.
Intervention Participants are allocated to one of three 12-week programs delivered in small groups, with two sessions per week (24 sessions total). Each program is supervised by trained professionals and delivered in an on-campus setting. Sessions follow a standardized structure that includes preparation/warm-up, a main training component, and a closing/cool-down or debriefing period, adapted to the characteristics of each modality.
Motor-cognitive dual-task exercise (moderate-to-vigorous intensity): sessions combine aerobic/functional exercises with concurrent cognitive demands targeting core executive components (e.g., working memory updating, inhibitory control, and cognitive flexibility), implemented through standardized verbal instructions and visual stimuli. Effort is monitored using perceived exertion and heart rate checks, with planned progression across weeks to maintain an appropriate training stimulus.
Tai Chi (low-to-moderate intensity mind-body intervention): sessions emphasize postural alignment, slow coordinated sequences, weight shifting, and breath-movement synchronization, with an explicit focus on mindful attention and motor sequence learning. Intensity is maintained within low-to-moderate ranges and progressed gradually by increasing sequence complexity and practice continuity.
Digital cognitive stimulation: sessions involve supervised use of a digital platform for structured graphomotor and cognitive tasks designed to engage sustained/selective attention, working memory, planning, and other executive processes. Task difficulty is adjusted to participant performance to ensure a progressive cognitive load and to promote adherence and standardized delivery.
Assessment schedule and procedures Assessments are conducted at baseline and after completion of the 12-week program using standardized procedures and consistent testing order. The cognitive assessment battery is administered by trained evaluators and includes measures aligned with the three-component model of executive functions (working memory, inhibitory control, and cognitive flexibility). Stress is assessed using a validated academic stress self-report scale and salivary cortisol measurement. Physical fitness and health-related indicators are collected to characterize participants and to examine whether changes in physical condition co-occur with cognitive and stress outcomes. Attendance is recorded at every session to quantify adherence.
For salivary cortisol, samples are collected in a controlled laboratory setting using passive drool procedures. Participants receive standardized pre-collection instructions (e.g., avoiding food and beverages other than water, tobacco, and oral hygiene for a specified period before sampling) to minimize pre-analytical variability. Samples are processed following laboratory protocols (e.g., centrifugation and appropriate storage conditions) and analyzed using enzyme immunoassay methods according to manufacturer specifications. Collection times are standardized to reduce circadian-related variability.
Data quality, adherence, and safety monitoring Intervention fidelity is supported through standardized session plans, trained instructors, and systematic recording of session attendance. To promote retention and minimize missed sessions, the study uses flexible scheduling options and structured reminders. Any adverse events or discomfort reported during sessions or assessments are documented and managed according to institutional procedures, with referral to appropriate services if needed.
Planned analysis approach (overview) Analyses will follow a pre-post framework to estimate within-group change and between-group differences over time. Group-by-time effects will be tested using repeated-measures models, with appropriate post-hoc comparisons when significant interactions are identified. Standard data checks (distributional assumptions and homoscedasticity) will be performed. Missing data will be addressed using principled methods (e.g., multiple imputation) consistent with recommendations for clinical trials. Effect sizes will be reported to support interpretation of clinical and practical relevance.
Expected contribution This trial aims to generate comparative evidence on three feasible intervention strategies for first-year university students by integrating cognitive, psychological, physiological, and physical assessments. Findings may inform scalable health-promotion and academic-adaptation programs in higher education contexts, particularly in Chile and other Latin American settings where experimental longitudinal evidence remains limited.
Rationale and background Transitioning into higher education is a developmental period characterized by increased academic demands, changes in routines, and new social and environmental stressors. Elevated and persistent stress during this stage has been associated with poorer well-being and may negatively impact cognitive performance, particularly executive functions (EF). EF-including working memory, inhibitory control, and cognitive flexibility-are higher-order cognitive processes crucial for academic performance, self-regulated learning, and problem solving. Because EF continue developing into early adulthood, the university context provides an opportunity for preventive and promotive interventions aimed at strengthening cognitive resources that support academic adaptation.
Physical activity has been associated with cognitive and mental-health benefits in university populations, including improvements in attention and EF and reductions in stress-related symptoms. Evidence indicates that cognitive outcomes may depend not only on exercise intensity but also on the cognitive demands embedded in the activity. Motor-cognitive dual-task training explicitly combines physical and cognitive loads (e.g., working memory, inhibitory control, and set shifting) and may produce larger EF gains than exercise alone by increasing executive control requirements during movement. In parallel, mind-body practices such as Tai Chi integrate mindful attention, controlled breathing, and coordinated movement and have been linked to improved psychological well-being and stress regulation. A third approach, digital cognitive stimulation, uses structured adaptive tasks to target executive components directly and can be delivered in a scalable and standardized format. However, there is limited experimental evidence comparing these modalities head-to-head within the same randomized design, particularly in Latin American university settings.
Stress is assessed using both self-report and a physiological biomarker. Cortisol is a key end-product of hypothalamic-pituitary-adrenal (HPA) axis activity and exhibits a circadian rhythm, making it a relevant biomarker for stress-related physiological regulation. Salivary sampling provides a non-invasive approach suitable for educational settings. Integrating psychological and physiological measures can contribute to a more comprehensive understanding of intervention effects and potential mechanisms.
Design and setting The study uses a three-arm randomized controlled design with pre-intervention (baseline) and post-intervention assessments. The trial is conducted at Universidad San Sebastián (Concepción campus, Chile) and targets first-year students from health-related academic programs. Participants are recruited during the university induction period and enrolled after completing baseline assessments. Given the nature of behavioral interventions, participants and instructors are not blinded; however, outcome assessors are trained and remain blinded to group allocation, and procedures are standardized to reduce performance and measurement bias.
Intervention Participants are allocated to one of three 12-week programs delivered in small groups, with two sessions per week (24 sessions total). Each program is supervised by trained professionals and delivered in an on-campus setting. Sessions follow a standardized structure that includes preparation/warm-up, a main training component, and a closing/cool-down or debriefing period, adapted to the characteristics of each modality.
Motor-cognitive dual-task exercise (moderate-to-vigorous intensity): sessions combine aerobic/functional exercises with concurrent cognitive demands targeting core executive components (e.g., working memory updating, inhibitory control, and cognitive flexibility), implemented through standardized verbal instructions and visual stimuli. Effort is monitored using perceived exertion and heart rate checks, with planned progression across weeks to maintain an appropriate training stimulus.
Tai Chi (low-to-moderate intensity mind-body intervention): sessions emphasize postural alignment, slow coordinated sequences, weight shifting, and breath-movement synchronization, with an explicit focus on mindful attention and motor sequence learning. Intensity is maintained within low-to-moderate ranges and progressed gradually by increasing sequence complexity and practice continuity.
Digital cognitive stimulation: sessions involve supervised use of a digital platform for structured graphomotor and cognitive tasks designed to engage sustained/selective attention, working memory, planning, and other executive processes. Task difficulty is adjusted to participant performance to ensure a progressive cognitive load and to promote adherence and standardized delivery.
Assessment schedule and procedures Assessments are conducted at baseline and after completion of the 12-week program using standardized procedures and consistent testing order. The cognitive assessment battery is administered by trained evaluators and includes measures aligned with the three-component model of executive functions (working memory, inhibitory control, and cognitive flexibility). Stress is assessed using a validated academic stress self-report scale and salivary cortisol measurement. Physical fitness and health-related indicators are collected to characterize participants and to examine whether changes in physical condition co-occur with cognitive and stress outcomes. Attendance is recorded at every session to quantify adherence.
For salivary cortisol, samples are collected in a controlled laboratory setting using passive drool procedures. Participants receive standardized pre-collection instructions (e.g., avoiding food and beverages other than water, tobacco, and oral hygiene for a specified period before sampling) to minimize pre-analytical variability. Samples are processed following laboratory protocols (e.g., centrifugation and appropriate storage conditions) and analyzed using enzyme immunoassay methods according to manufacturer specifications. Collection times are standardized to reduce circadian-related variability.
Data quality, adherence, and safety monitoring Intervention fidelity is supported through standardized session plans, trained instructors, and systematic recording of session attendance. To promote retention and minimize missed sessions, the study uses flexible scheduling options and structured reminders. Any adverse events or discomfort reported during sessions or assessments are documented and managed according to institutional procedures, with referral to appropriate services if needed.
Planned analysis approach (overview) Analyses will follow a pre-post framework to estimate within-group change and between-group differences over time. Group-by-time effects will be tested using repeated-measures models, with appropriate post-hoc comparisons when significant interactions are identified. Standard data checks (distributional assumptions and homoscedasticity) will be performed. Missing data will be addressed using principled methods (e.g., multiple imputation) consistent with recommendations for clinical trials. Effect sizes will be reported to support interpretation of clinical and practical relevance.
Expected contribution This trial aims to generate comparative evidence on three feasible intervention strategies for first-year university students by integrating cognitive, psychological, physiological, and physical assessments. Findings may inform scalable health-promotion and academic-adaptation programs in higher education contexts, particularly in Chile and other Latin American settings where experimental longitudinal evidence remains limited.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 11251478 | OTHER_GRANT | Agencia Nacional de Investigación y Desarrollo (ANID), Chile | View |