Active Young, Healthy Mind. The YoungFitT Project

NCT06406283 | Recruiting

• 2 other identifiers: UBPID2022-137776OB-100
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of YoungFitT Project is to study the effect and neuro-psycho-biological mechanisms of mind and body interventions, also in the form of virtual reality (VR), on brain health, cognitive and psychological well-being of college students. The investigators have adopted an inter and multidisciplinary and multimodal approach to provide a more integrative perspective using cognitive, psychological, biochemical, and neuroimaging measurements. The investigators hypothesize that all three interventions Mindfulness-Based Stress Reduction (MBSR), Qigong, and High-Intensity Functional Training (HIFT) will produce gains in cognitive functions and psychological well-being at three months compared to baseline. Also, all three interventions will induce changes in the microbiota and brain structure and function. Finally, using a VR environment for these interventions will provide greater adherence and cognitive and psychological well-being benefits than conventional training.

Conditions

University Students

Keywords

Well-being; Physical exercise; Qigong; Mindfulness; Neuroimaging; Intervention; Randomization; Cognition; Virtual environment

Outcome Measures

Primary Outcomes (17)

• Changes in immediate verbal attention

  Direct Digit Span, subtest from the Wechsler Adult Intelligence Scale - Third Edition (WAIS-III). Span. Direct score. Range 0-9. Higher scores indicate better performance.

  Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)

• Changes in processing speed

  Symbol-Digit Coding subtest from the Wechsler Adult Intelligence Scale - Third Edition (WAIS-III). Direct score. Range 0-133. Higher scores indicate better performance.

  Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)

• Changes in visual attention

  Trail Making Test Part A. Seconds to complete the numerical sequence. Direct score. More time indicates worse performance.

  Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)

• Changes in verbal memory

  Rey Auditory Verbal Learning Test. Direct score. Range 0-75. Higher scores indicate better performance.

  Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)

• Changes in visual memory

  Rey-Osterrieth Complex Figure. The memory drawing accuracy at 3-5 minutes. Direct score. Range 0-36. Higher scores indicate better performance.

  Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)

• Changes in Executive Function - Flexibility

  Trail Making Test Part B. Seconds to complete the alphanumeric sequence. Direct score. More time indicates worse performance.

  Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)

• Changes in Executive Function - Inhibition

  Stroop Color and Word Test. Interference of the Stroop Color and Word Test. Interference is calculated as follows: CW - ((W \* C) / (W + C)). Higher scores indicate better performance. Negative values are possible, meaning a bad performance.

  Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)

• Changes in Executive Function - Verbal Fluency

  Phonetic Fluency is measured using the Controlled Oral Word Association Test, spanish adaptation, and semantic fluency test using the category Animal. The total number of evoked words starting with the letters P, M, and R (60 seconds for each letter) and animals (60 seconds). Direct score. Higher scores indicate better performance.

  Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)

• Change in verbal digit working memory

  Backward Digit Span subtest from the Wechsler Adult Intelligence Scale - Third Edition (WAIS-III). Span. Direct score. Range 0-8. Higher scores indicate better performance.

  Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)

• Changes in Verbal Comprehension

  Vocabulary subtest from the Wechsler Adult Intelligence Scale - Third Edition (WAIS-III). Direct score. Range 0-66. Higher scores indicate better performance.

  Baseline (2 weeks before)

• Changes in Psychological symptoms

  90 Symptoms Inventory (90-SCL-R). Direct scores from 0 to 4. Higher scores indicate more symptomatology.

  Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)

• Changes in Self-esteem

  Rosenberg Self-esteem scale (RSE). Direct scores from 10 to 40. Higher scores indicate higher self-esteem.

  Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)

• Changes in Depression, anxiety and stress

  Depression, Anxiety and Stress Scale-21 (DASS-21). Direct score. Range 0-126. Higher scores indicate more global symptoms

  Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)

• Changes in Mindfulness

  Five facet mindfulness questionnaire (FFMQ). Direct scores from 39 to 195. Higher scores indicate more Mindfulness levels.

  Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)

• Changes in Self-efficacy

  General self-efficacy scale (GSE). Direct scores from 10 to 40. Higher scores indicate more self-eficacy.

  Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)

• Changes in Sleep quality

  Pittsburgh Sleep Quality Index (PSQI). Direct score. Range 0-21. Lower scores indicate better sleep quality.

  Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)

• Changes in Diet

  Mediterranean Diet Assessment Tool (PREDIMED). Direct score. Range 0-14. Higher scores indicate more adherence to a Mediterranean diet.

  Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)

Secondary Outcomes (18)

• Changes in Physical activity

  Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)

• Changes in Anthropometric Measurements - Height

  Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)

• Changes in Anthropometric Measurements - Weight

  Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)

• Changes in Anthropometric Measurements - Body Mass

  Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)

• Changes in Anthropometric Measurements - Waist and hip circumference

  Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)

Study Arms (3)

High-Intensity Functional Training (HIFT) Group

EXPERIMENTAL

Behavioral: High-Intensity Functional Training (HIFT)

Mindfulness Group

EXPERIMENTAL

Behavioral: Mindfulness-Based Stress Reduction Program (MBSR)

Qigong Group

EXPERIMENTAL

Behavioral: Qigong

Interventions

High-Intensity Functional Training (HIFT) BEHAVIORAL

This intervention will include three sessions per week: two group 60-minute zoom online synchronous sessions guided by experts and one individual autonomous session (a repetition of a chosen session of that week). The training protocol will be designed based on Cross-Training workouts, emphasizing high-intensity interval training combined with functional resistance-training movements.

High-Intensity Functional Training (HIFT) Group

Mindfulness-Based Stress Reduction Program (MBSR) BEHAVIORAL

This intervention follows the official MBSR program designed by Jon Kabat-Zinn with some adaptations, as we did in Bermudo-Gallaguet, et al. (2022). The intervention will occur three days a week, including one 120-minute online synchronous session and two 20-40 min individual practices. The intensity of physical exercise will be adjusted to personal baseline characteristics.

Mindfulness Group

Qigong BEHAVIORAL

This intervention will include three sessions per week: two group 60-minute zoom online synchronous sessions guided by experts and one individual autonomous session (a repetition of a chosen session of that week). The program includes the Baduanjin sequence, considered one of the most ancient and beneficial forms for physical and mental health within the Qigong tradition.

Qigong Group

Eligibility Criteria

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

You may qualify if:

• Individuals aged 18-25 years old
• Fluency in Catalan or Spanish (I.e., able to understand and speak)
• Accept to take part in the study and sign the informed consent according to the Declaration of Helsinki.

You may not qualify if:

• Severe Neurological or psychiatric history
• Alcohol or drug abuse history
• Injury that prevents exercise
• Claustrophobia
• Medical device (e.g., pacemaker implants, stents)
• Other metal objects in the body
• Dizziness
• Contraindications or troubles that could condition the use of VR

Sponsors & Collaborators

• University of Barcelona: lead
• University Ramon Llull: collaborator
• ICREA Academia: collaborator
• Institut de Neurociències de la Universitat de Barcelona: collaborator
• Institut de Recerca Sant Joan de Déu (CERCA center): collaborator
• EventLab: collaborator
• INEFC: collaborator
• Nirakara Lab: collaborator
• Adventhealth Research Institute, Neuroscience: collaborator
• University of Murdock: collaborator

Study Sites (1)

Maria Mataro

Barcelona, Spain

RECRUITING

Related Publications (1)

• Rostami S, Bermudo-Gallaguet A, Camins-Vila N, Ferrer-Uris B, Busquets A, Ribera M, Coll L, Gallego Vila J, Oliva Martinez R, Slater M, Garcia Diez G, Perales Castellanos N, Larrosa M, Bielsa-Pascual J, Toran-Montserrat P, Bruna Rabassa O, Guerra-Balic M, Erickson KI, Brown B, Serrat MM. The YoungFitT project: Study protocol for a randomized mixed-methods trial of physical exercise and mind-body interventions, with or without virtual reality, in university students. PLoS One. 2025 Aug 1;20(8):e0328538. doi: 10.1371/journal.pone.0328538. eCollection 2025.

  PMID: 40748900 DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Qigong

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Breathing Exercises; Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Maria Mataró, PhD

  University of Barcelona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Mataró, PhD

CONTACT

+34933125052; mmataro@ub.edu

Samira Rostami, PhD

CONTACT

Samira7rostami@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The randomization sequence is concealed (blinded) from research personnel, so that the investigators are not aware of whether a particular subject has been randomized to one of the intervention groups or to the active control group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: In Study 1: 174 participants, all of them university students aged 18 to 25 years old, are randomly assigned to one of three arms: The first group (n=58) receives HIFT. The second group (n=58) receives Qigong. Finally, the third group (n=58) receives MBSR. In Study 1: 45 participants, all of them university students aged 18 to 25 years old, are randomly assigned to one of three arms: The first group (n=15) receives HIFT-VR. The second group (n=15) receives Qigong-VR. Finally, the third group (n=15) receives MBSR-VR.

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: May 9, 2024
• Study Start: December 20, 2023
• Primary Completion (Estimated): May 18, 2026
• Study Completion (Estimated): September 18, 2026
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)