Muévete conCiencia Project: Protocol for a Randomized Controlled Trial of Physical Exercise and Mind-Body Interventions in University Students
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 297
- 试验地点
- 1
- 主要终点
- Working memory
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Dual-Task (DT)
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.
干预措施: Motor-Cognitive Dual-Task Exercise (DT) (Behavioral)
Tai Chi (TC)
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.
干预措施: Tai Chi Mind-Body Exercise (TC) (Behavioral)
Cognitive Training (CT)
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.
干预措施: Cognitive Stimulation (CS) (Behavioral)
结局指标
主要结局
Working memory
时间窗: Baseline (pre-intervention) and immediately after completion of the 12-week intervention (post-intervention).
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.
Inhibitory Control
时间窗: Baseline (pre-intervention) and immediately after completion of the 12-week intervention (post-intervention).
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.
Cognitive Flexibility
时间窗: Baseline (pre-intervention) and immediately after completion of the 12-week intervention (post-intervention)
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.
次要结局
- Academic stress(Baseline (pre-intervention) and immediately after completion of the 12-week intervention (post-intervention).)
- 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).)
- 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).)
- Body Weight(Baseline (pre-intervention) and immediately after completion of the 12-week intervention (post-intervention).)
- Height(Baseline (pre-intervention) and immediately after completion of the 12-week intervention (post-intervention).)
- Body Fat Percentage(Baseline (pre-intervention) and immediately after completion of the 12-week intervention (post-intervention).)
研究者
Montserrat Rodríguez Vera
Assistant Professor
Universidad San Sebastián