Muévete conCiencia: Exercise and Mind-Body Program for First-Year University Students

NCT07443904 | Not Yet Recruiting

• 2 other identifiers: 572511251478
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Healthy Adult Participants

Keywords

executive function; stress; salivary cortisol; mind-body exercise; Dual-task training; Tai Chi; Cognitive training; university students

Outcome Measures

Primary Outcomes (3)

• Working memory

  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.

  Baseline (pre-intervention) and immediately after completion of the 12-week intervention (post-intervention).

• Inhibitory Control

  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.

  Baseline (pre-intervention) and immediately after completion of the 12-week intervention (post-intervention).

• Cognitive Flexibility

  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.

  Baseline (pre-intervention) and immediately after completion of the 12-week intervention (post-intervention)

Secondary Outcomes (8)

• Physiological Stress Salivary Cortisol

  Baseline (pre-intervention) and immediately after completion of the 12-week intervention (post-intervention).

• Depression, anxiety, and Stress symptoms

  Baseline (pre-intervention) and immediately after completion of the 12-week intervention (post-intervention).

• Academic stress

  Baseline (pre-intervention) and immediately after completion of the 12-week intervention (post-intervention).

• Physical Activity

  Baseline (pre-intervention) and immediately after completion of the 12-week intervention (post-intervention).

• Muscle Strength

  Baseline (pre-intervention) and immediately after completion of the 12-week intervention (post-intervention).

Other Outcomes (1)

• Intervention adherence

  Throughout the 12-week intervention period

Study Arms (3)

Motor-Cognitive Dual-Task Exercise

EXPERIMENTAL

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.

Behavioral: Motor-Cognitive Dual-Task Exercise (DT)

Tai Chi Mind-Body Exercise

EXPERIMENTAL

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.

Behavioral: Tai Chi Mind-Body Exercise (TC)

Cognitive Stimulation (CS)

ACTIVE COMPARATOR

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.

Behavioral: Cognitive Stimulation (CS)

Interventions

Motor-Cognitive Dual-Task Exercise (DT) BEHAVIORAL

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.

Motor-Cognitive Dual-Task Exercise

Tai Chi Mind-Body Exercise (TC) BEHAVIORAL

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

Tai Chi Mind-Body Exercise

Cognitive Stimulation (CS) BEHAVIORAL

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.

Cognitive Stimulation (CS)

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Enrolled in the first year of a health-related undergraduate program at Universidad San Sebastián, Concepción campus (Chile), academic cohort 2026.
• Willing and able to attend scheduled intervention sessions and complete baseline and post-intervention assessments.
• Provides written informed consent prior to participation.

You may not qualify if:

• Diagnosis of neurological disease or severe psychiatric disorder that may interfere with participation or outcome validity.
• Medical or musculoskeletal condition that contraindicates participation in moderate-to-vigorous physical exercise.
• Regular participation in another structured exercise program during the study period or being a competitive athlete.

Sponsors & Collaborators

• Universidad San Sebastián: lead
• Agencia Nacional de Investigación y Desarrollo: collaborator

Study Sites (1)

Universidad San Sebastián

Concepción, Región del Biobío, 4030375, Chile

Location

Central Study Contacts

Montserrat A Rodríguez, Doctor of Psychology

CONTACT

+56984041657; montserrat.rodriguez@uss.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 8, 2026
• First Posted: March 2, 2026
• Study Start: March 1, 2026
• Primary Completion: March 31, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 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.
• Access Criteria: 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.

Locations

CL (1)