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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Due to the nature of the behavioral interventions, participants and intervention providers are not blinded to group assignment. Outcome assessors remain blinded to intervention allocation throughout baseline and post-intervention assessments. No other parties are masked in this trial.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study uses a parallel-group randomized controlled design with three intervention arms. Eligible participants are randomly assigned in a 1:1:1 ratio to one of the following groups: (1) motor-cognitive dual-task exercise, (2) Tai Chi mind-body exercise, or (3) digital cognitive training. Participants remain in their assigned group throughout the 12-week intervention period, and outcomes are assessed before and after the intervention.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-24', 'studyFirstSubmitDate': '2026-02-08', 'studyFirstSubmitQcDate': '2026-02-24', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Intervention adherence', 'timeFrame': 'Throughout the 12-week intervention period', 'description': 'Intervention adherence will be assessed by recording attendance at the scheduled intervention sessions. A participation rate will be calculated as the percentage of attended sessions relative to the total number of planned sessions (attendance/24 sessions × 100). Higher percentages indicate greater adherence to the intervention.'}], 'primaryOutcomes': [{'measure': 'Working memory', 'timeFrame': 'Baseline (pre-intervention) and immediately after completion of the 12-week intervention (post-intervention).', 'description': 'Working memory will be assessed using the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) Digit Span subtest (total raw score). Scores range from 0 to 48. Higher scores indicate better working memory performance.'}, {'measure': 'Inhibitory Control', 'timeFrame': 'Baseline (pre-intervention) and immediately after completion of the 12-week intervention (post-intervention).', 'description': 'Inhibitory control will be assessed using the Stroop Color and Word Test. Performance will be recorded as the number of correctly completed items within the standard time limit. Scores range from 0 to 100. Higher scores indicate better inhibitory control.'}, {'measure': 'Cognitive Flexibility', 'timeFrame': 'Baseline (pre-intervention) and immediately after completion of the 12-week intervention (post-intervention)', 'description': 'Trail Making Test Parts A and B (TMT) using normative data for the Latin American Spanish-speaking adult population. The TMT assesses the ability to alternate between mental sets and manage divided attention demands. The score is the completion time for each part of the TMT-A (Minimum = 0; maximum = 100) and TMT-B (Minimum = 0; maximum = 300). Lower completion time indicates better performance.'}], 'secondaryOutcomes': [{'measure': 'Physiological Stress Salivary Cortisol', 'timeFrame': 'Baseline (pre-intervention) and immediately after completion of the 12-week intervention (post-intervention).', 'description': 'Salivary cortisol levels reflect physiological stress associated with hypothalamic-pituitary-adrenal (HPA) axis activity. Changes in physiological stress in response to the interventions will be assessed non-invasively through salivary cortisol determination using a competitive ELISA assay. Cortisol concentrations will be expressed in µg/dL. The analytical measurement range of the assay is approximately 0.012-3.0 µg/dL. Higher values indicate greater physiological stress.'}, {'measure': 'Depression, anxiety, and Stress symptoms', 'timeFrame': 'Baseline (pre-intervention) and immediately after completion of the 12-week intervention (post-intervention).', 'description': 'Symptoms of depression, anxiety, and stress will be assessed using the Depression Anxiety Stress Scales (DASS-21). The scale consists of 21 items rated on a Likert scale from 0 ("did not apply to me at all") to 5 ("applied to me very much or most of the time"), reflecting the extent to which each statement describes the participant\'s experiences over the previous week (Minimum = 0; maximum = 126). Higher scores indicate more global symptoms. The DASS-21 is a brief self-report measure with well-established psychometric properties in university student populations.'}, {'measure': 'Academic stress', 'timeFrame': 'Baseline (pre-intervention) and immediately after completion of the 12-week intervention (post-intervention).', 'description': 'Academic Stress Scale (Barraza-Macías) - 33-item self-report instrument assessing academic stressors, coping strategies, and stress-related physical, psychological, and behavioral reactions. the total score range Minimum = 33; maximum = 165. Higher scores indicate more global symptoms.'}, {'measure': 'Physical Activity', 'timeFrame': 'Baseline (pre-intervention) and immediately after completion of the 12-week intervention (post-intervention).', 'description': 'Physical activity will be assessed using the International Physical Activity Questionnaire - Short Form (IPAQ-SF). Physical activity will be expressed as MET-minutes per week depending on reported activity. Higher scores indicate higher levels of physical activity.'}, {'measure': 'Muscle Strength', 'timeFrame': 'Baseline (pre-intervention) and immediately after completion of the 12-week intervention (post-intervention).', 'description': 'Muscle strength will be measured using handgrip dynamometry. Three trials will be performed for each hand, and the highest value will be recorded in kilograms-force (kg/f). Higher values indicate greater muscle strength.'}, {'measure': 'Body Weight', 'timeFrame': 'Baseline (pre-intervention) and immediately after completion of the 12-week intervention (post-intervention).', 'description': 'Body weight will be assessed using bioelectrical impedance analysis and expressed in kilograms (kg). Higher values indicate greater body weight.'}, {'measure': 'Height', 'timeFrame': 'Baseline (pre-intervention) and immediately after completion of the 12-week intervention (post-intervention).', 'description': 'Height will be measured in meters (m) using a standardized stadiometer or wall-mounted measuring tape, with participants standing upright without shoes. Higher values indicate greater height.'}, {'measure': 'Body Fat Percentage', 'timeFrame': 'Baseline (pre-intervention) and immediately after completion of the 12-week intervention (post-intervention).', 'description': 'Body fat percentage will be assessed using bioelectrical impedance analysis and expressed as percentage of total body mass (%). Higher values indicate greater adiposity and poorer body composition.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['executive function', 'stress', 'salivary cortisol', 'mind-body exercise', 'Dual-task training', 'Tai Chi', 'Cognitive training', 'university students'], 'conditions': ['Healthy', 'Healthy Adult Participants']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nThe main questions it aims to answer are:\n\nDo 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?\n\nResearchers will compare:\n\n* high-intensity dual-task exercise group,\n* low-to-moderate intensity mind-body exercise group (Tai Chi), and\n* cognitive stimulation control group,\n\nTo determine whether physically integrated motor-cognitive training produces greater improvements in executive functions and stress biomarkers than mind-body exercise or cognitive stimulation alone.\n\nParticipants will:\n\nComplete 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.\n\nParticipate for 12 weeks (22 sessions, twice per week) in one of the following interventions:\n\nHigh-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.\n\nAll sessions will be conducted in supervised, controlled settings by trained professionals, following standardized protocols to ensure safety, consistency, and adherence.', 'detailedDescription': '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.\n\nRationale 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.\n\nPhysical 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.\n\nStress 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.\n\nDesign 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.\n\nIntervention 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.\n\nMotor-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.\n\nTai 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.\n\nDigital 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.\n\nAssessment 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.\n\nFor 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.\n\nData 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.\n\nPlanned 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.\n\nExpected 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Enrolled in the first year of a health-related undergraduate program at Universidad San Sebastián, Concepción campus (Chile), academic cohort 2026.\n* Willing and able to attend scheduled intervention sessions and complete baseline and post-intervention assessments.\n* Provides written informed consent prior to participation.\n\nExclusion Criteria:\n\n* Diagnosis of neurological disease or severe psychiatric disorder that may interfere with participation or outcome validity.\n* Medical or musculoskeletal condition that contraindicates participation in moderate-to-vigorous physical exercise.\n* Regular participation in another structured exercise program during the study period or being a competitive athlete.'}, 'identificationModule': {'nctId': 'NCT07443904', 'briefTitle': 'Muévete conCiencia: Exercise and Mind-Body Program for First-Year University Students', 'organization': {'class': 'OTHER', 'fullName': 'Universidad San Sebastián'}, 'officialTitle': 'Muévete conCiencia Project: Protocol for a Randomized Controlled Trial of Physical Exercise and Mind-Body Interventions in University Students', 'orgStudyIdInfo': {'id': '5725'}, 'secondaryIdInfos': [{'id': '11251478', 'type': 'OTHER_GRANT', 'domain': 'Agencia Nacional de Investigación y Desarrollo (ANID), Chile'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Motor-Cognitive Dual-Task Exercise', 'description': 'Sessions are conducted twice per week and combine moderate-to-vigorous physical exercise with concurrent cognitive demands targeting executive functions such as working memory, inhibitory control, and cognitive flexibility. Exercise intensity is progressively increased and monitored using perceived exertion and heart rate checks. Each session includes a warm-up, a main dual-task training phase, and a cool-down period.', 'interventionNames': ['Behavioral: Motor-Cognitive Dual-Task Exercise (DT)']}, {'type': 'EXPERIMENTAL', 'label': 'Tai Chi Mind-Body Exercise', 'description': 'The intervention consists of low-to-moderate intensity practice emphasizing slow, coordinated movements, postural control, weight shifting, breathing regulation, and mindful attention. Sessions follow a structured format including preparation, practice of progressive Tai Chi sequences, and a closing phase focused on relaxation and integration.', 'interventionNames': ['Behavioral: Tai Chi Mind-Body Exercise (TC)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cognitive Stimulation (CS)', 'description': 'The intervention uses a computerized platform to deliver structured and adaptive graphomotor and cognitive tasks targeting executive functions, including attention, working memory, planning, and cognitive flexibility. Sessions are conducted in person under professional supervision and include task familiarization, progressive cognitive training, and feedback.', 'interventionNames': ['Behavioral: Cognitive Stimulation (CS)']}], 'interventions': [{'name': 'Motor-Cognitive Dual-Task Exercise (DT)', 'type': 'BEHAVIORAL', 'description': "sessions include warm-up, circuit-based functional training integrating simultaneous motor and cognitive tasks (e.g., working memory, inhibitory control, cognitive flexibility), and cool-down. Exercise intensity is moderate to vigorous (≈64-89% HRmax), monitored using heart-rate monitoring and Borg's perceived exertion scale, with progressive overload across weeks.", 'armGroupLabels': ['Motor-Cognitive Dual-Task Exercise']}, {'name': 'Tai Chi Mind-Body Exercise (TC)', 'type': 'BEHAVIORAL', 'description': 'Tai Chi program based on a simplified Yang-style sequence. Sessions emphasize slow coordinated movements, balance, breathing, and mindful attention. Exercise intensity is low to moderate (≈55-70% HRmax), with progressive learning of movement sequences and focus on physiological and emotional', 'armGroupLabels': ['Tai Chi Mind-Body Exercise']}, {'name': 'Cognitive Stimulation (CS)', 'type': 'BEHAVIORAL', 'description': 'Cognitive training program using digital graphomotor tasks delivered via specialized software. Sessions target executive functions (attention, working memory, planning, inhibitory control) through adaptive tasks with immediate feedback and individualized difficulty adjustment.', 'armGroupLabels': ['Cognitive Stimulation (CS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4030375', 'city': 'Concepción', 'state': 'Región del Biobío', 'country': 'Chile', 'facility': 'Universidad San Sebastián', 'geoPoint': {'lat': -36.82699, 'lon': -73.04977}}], 'centralContacts': [{'name': 'Montserrat A Rodríguez, Doctor of Psychology', 'role': 'CONTACT', 'email': 'montserrat.rodriguez@uss.cl', 'phone': '+56984041657'}]}, 'ipdSharingStatementModule': {'url': 'https://www.linkedin.com/in/montserrat-rodr%C3%ADguez-vera-7a134270/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'IPD and supporting documentation will be made available beginning 6 months after publication of the primary study results and will remain available for a period of 5 years.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data (IPD) underlying the results reported in the primary publications of this study will be made available. The shared IPD will include demographic variables, outcome measures, and relevant covariates used in the statistical analyses, along with a corresponding data dictionary. Data that could compromise participant privacy or confidentiality will not be shared.', 'accessCriteria': 'Access to the de-identified IPD and supporting documents will be granted to qualified researchers who submit a reasonable research proposal. Requests will be reviewed by the principal investigator and the research team. Data will be shared for non-commercial research purposes only, and access will require the signing of a data use agreement to ensure appropriate use and protection of the data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad San Sebastián', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agencia Nacional de Investigación y Desarrollo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Montserrat Rodríguez Vera', 'investigatorAffiliation': 'Universidad San Sebastián'}}}}