NCT07443904

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 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 training 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 training 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 training sessions using a structured digital program. All sessions will be conducted in supervised, controlled settings by trained professionals, following standardized protocols to ensure safety, consistency, and adherence.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
297

participants targeted

Target at P75+ for not_applicable healthy

Timeline
9mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Aug 2026Apr 2027

First Submitted

Initial submission to the registry

February 8, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 2, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

July 24, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

February 8, 2026

Last Update Submit

July 22, 2026

Conditions

HealthyHealthy Adult Participants

Keywords

executive functionstresssalivary cortisolmind-body exerciseDual-task trainingTai ChiCognitive traininguniversity 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).

  • +3 more secondary outcomes

Other Outcomes (1)

  • Intervention adherence

    Throughout the 12-week intervention period

Study Arms (3)

Dual-Task (DT)

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 (TC)

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 Training (CT)

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.

Dual-Task (DT)
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 (TC)
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 Training (CT)

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Enrolled in a health-related undergraduate program at Universidad San Sebastián, Concepción campus (Chile).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad San Sebastián

Concepción, Biobio, 4030375, Chile

Location

Central Study Contacts

Montserrat A Rodríguez, Doctor of Psychology

CONTACT

+56984041657montserrat.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
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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 8, 2026

First Posted

March 2, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

April 30, 2027

Last Updated

July 24, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

After completion of the study and publication of the primary results, the de-identified dataset underlying the reported findings will be deposited in the international open-access repository Figshare, together with the corresponding data dictionary and analysis code. No directly identifying information will be publicly shared.

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 4 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.
More information

Locations

CL(1)