NCT07044154

Brief Summary

Currently, university students face physical and mental health issues, which are reflected in low levels of physical activity, a decline in healthy eating behaviors, and a high prevalence of mental health symptoms such as stress, anxiety, and depression. Therefore, it is necessary to develop safe, effective, and sustainable interventions that support comprehensive health and provide formative experiences that reinforce the importance of developing healthy lifestyle habits and self-care. In this regard, Tai Chi has been shown to offer physical and mental health benefits. Tai Chi is a low- to moderate-intensity exercise with low joint impact, which facilitates the transition from a sedentary to an active lifestyle. Considering the health problems experienced by university students, it is proposed that a Tai Chi intervention could help produce beneficial effects on both physical and mental health. In this context, the present study aims to implement Tai Chi classes with the objective of determining their effect on the cardiac autonomic system, mental health, and the perception of benefits, facilitators, and barriers among participating university students compared to a control group.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
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 Progress73%
Jul 2025Aug 2026

First Submitted

Initial submission to the registry

June 12, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 29, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

1.1 years

First QC Date

June 12, 2025

Last Update Submit

April 23, 2026

Conditions

Keywords

university studentsSun Tai Chicardiac autonomic modulationcardiopulmonary capacitymental healthqualitative perception

Outcome Measures

Primary Outcomes (11)

  • DASS-21 stress

    Stress will be measured using the stress subdomain of the DASS-21, which ranges from 0 to 21 points, with higher scores indicating higher levels of stress.

    Initial evaluation: Prior to the intervention (week 0) Final evaluation: After 6 weeks of intervention

  • DASS-21 anxiety

    Anxiety will be measured using the anxiety subdomain of the DASS-21, which ranges from 0 to 21 points, with higher scores indicating higher levels of anxiety.

    Initial evaluation: Prior to the intervention (week 0) Final evaluation: After 6 weeks of intervention

  • DASS-21 depression

    Depression will be measured using the depression subdomain of the DASS-21, which ranges from 0 to 21 points, with higher scores indicating higher levels of depression.

    Initial evaluation: Prior to the intervention (week 0) Final evaluation: After 6 weeks of intervention

  • Low frequency (LF)

    LF (ms2) is an index of parasympathetic and sympathetic cardiac autonomic modulation derived from the analysis of RR intervals (iRR).

    Initial evaluation: Prior to the intervention (week 0) Final evaluation: After 6 weeks of intervention

  • High frequency (HF)

    HF (ms2) is an index of parasympathetic cardiac autonomic modulation derived from the analysis of RR intervals (iRR).

    Initial evaluation: Prior to the intervention (week 0) Final evaluation: After 6 weeks of intervention

  • Low frequency/Hight frequency ratio (LF/HF)

    LF/HF is an index reflecting the balance between the parasympathetic and sympathetic cardiac autonomic modulation derived from the analysis of RR intervals (iRR).

    Initial evaluation: Prior to the intervention (week 0) Final evaluation: After 6 weeks of intervention

  • Pattern with no variation (0V)

    0V (%) is a pattern quantified through symbolic analyses of the RR intervals (iRR) reflecting the sympathetic cardiac modulation.

    Initial evaluation: Prior to the intervention (week 0) Final evaluation: After 6 weeks of intervention

  • Pattern with two unlike variation (2ULV)

    2ULV (%) is a pattern quantified through symbolic analyses of the RR intervals (iRR) reflecting the parasympathetic cardiac modulation.

    Initial evaluation: Prior to the intervention (week 0) Final evaluation: After 6 weeks of intervention

  • Baroreflex sensitivity (BRS)

    Baroreflex sensitivity is an index that assesses the heart rate response to changes in blood pressure and serves as an indicator of cardiovascular health.

    Time Frame: Initial evaluation: Prior to the intervention (week 0) Final evaluation: After 6 weeks of intervention

  • LFSAP

    The low-frequency index of systolic arterial pressure (LFSAP) reflects the vascular sympathetic autonomic modulation.

    Time Frame: Initial evaluation: Prior to the intervention (week 0) Final evaluation: After 6 weeks of intervention

  • Qualitative perception

    The qualitative perception of the participants will consider the perceived benefits, barriers, and facilitators. Data will be collected through semi-structured interviews and focus groups, using a qualitative approach.

    It will be conducted one week after the last Tai Chi class.

Secondary Outcomes (1)

  • VO2 Peak

    Initial evaluation: Prior to the intervention (week 0) Final evaluation: After 6 weeks of intervention

Study Arms (2)

Experimental: Sun Tai Chi Group

EXPERIMENTAL

The group will participate in 60-minute Sun Tai Chi sessions, held twice per week over a 6-week period.

Other: Tai Chi (Sun Style)

Control

OTHER

The group will receive informational material on healthy lifestyle topics and will not receive the Sun Tai Chi intervention.

Behavioral: Health lifestyle education

Interventions

The Sun Tai Chi intervention will be conducted by a Sun Tai Chi instructor with 7 years of teaching experience and will take place in an exercise room at the Catholic University of Maule. The intervention will last for 6 weeks, with a frequency of twice per week, and each class will last 60 minutes. Each session will begin with 10 minutes of warm-up exercises, followed by 20 minutes of basic Sun Tai Chi exercises, including lower limb movements, overall body mobility at a slow pace, precise movements of the hands and feet, and proper body alignment. This will be followed by 20 minutes of practice of the basic movement sequence of Sun Tai Chi (Taolú), and will conclude with 5 minutes of meditation and 5 minutes of relaxation exercises.

Experimental: Sun Tai Chi Group

The control group will receive guidance on a healthy physical and mental lifestyle.

Control

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Undergraduate university students
  • Aged 18 to 29 years
  • Both sexes
  • Present mental health symptoms assessed by the Depression Anxiety Stress Scales - 21 Items (DASS-21) questionnaire, according to cutoff points established by Lovibond et al., ranging from mild to severe in any of the subscales of stress (score 15 to 33), anxiety (score 8 to 19), or depression (score 10 to 27).
  • Report a healthy physical condition suitable for Tai Chi practice (self-reported).

You may not qualify if:

  • Engage in a high level of physical activity according to the International Physical Activity Questionnaire (IPAQ) or have regularly practiced moderate to high intensity physical activity in the last 3 months.
  • Report chronic illnesses that limit or contraindicate the practice of exercises required in Tai Chi.
  • Present cardiovascular, pulmonary, or neurological diseases.
  • Exhibit either no mental health impairment or severe impairment according to cutoff scores established by Lovibond et al. in the DASS-21 questionnaire (stress subscale score lower than 15 or greater than 33, anxiety subscale score lower than 8 or greater than 19, depression subscale score lower than 10 or greater than 27).
  • Present specific psychiatric diagnoses, such as Attention-Deficit/Hyperactivity Disorder (ADHD), self-reported.
  • Consume medications for mental health treatment.
  • Consume medications or substances that influence cardiac autonomic modulation (e.g., beta-blockers).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Católica del Maule

Talca, Maule Region, 3460000, Chile

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Central Study Contacts

Pamela Campos Rojas, PT

CONTACT

Antonio R Zamunér, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomized clinical trial will be conducted, using a mixed quantitative-qualitative phenomenological design, single-blind, prospective longitudinal, with non-probabilistic convenience sampling. First, the quantitative phase will be carried out, followed by the qualitative phase. Once the Tai Chi intervention is completed (beginning one week after the final session), the qualitative phase will begin.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
kinesiologist

Study Record Dates

First Submitted

June 12, 2025

First Posted

June 29, 2025

Study Start

July 1, 2025

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations