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NCT Number: NCT06406283

Active Young, Healthy Mind. The YoungFitT Project

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.

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Key information

Conditions

University Students Behavior Motor Activity

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The YoungFitT Project is a multicentric, prospective, parallel, single-blinded, three-arm, mixed-method randomized clinical trial with a sample of 219 participants. All of participants are university students aged 18 to 25 years old and will be randomized through a computer-generated allocation sequence with a 1:1:1 ratio and stratified by sex.

The YoungFitT Project is divided into two Studies:

Study 1: Online-based mind and body interventions. A total of 174 eligible university students will be randomized into three groups of HIFT, Qigong and MBSR (n=58). All interventions last 12 weeks.

Study 2: VR-based mind and body interventions. A total of 45 eligible university students will be randomized into three groups of HIFT-VR, Qigong-VR and MBSR-VR (n=15). All interventions last 12 weeks.

In both, within two weeks before and after the interventions, medical, cognitive, and physical assessments will be performed. Neuroimaging and biological samples will be collected in Study 1 only. There will be a follow-up 12 weeks after the end of the trials. This follow-up will assess online questionnaires about physical and psychological well-being.

The objectives of this project are:

  • To evaluate the effectiveness of HIFT, Qigong and MBSR interventions on the cognitive and psychological well-being of college students.
  • To study the intervention-induced changes in the microbiome and brain structure and function (volume of gray and white matter, microstructural integrity, functional connectivity) and their potential mediator effect on cognitive and psychological well-being outcomes.
  • To study the intervention-induced changes in the physical (physical activity and fitness status), mental (mindful thinking, sleep quality, and fatigue), and physiological stress (HRV) components and their potential mediator effect on cognitive and psychological well-being outcomes.
  • To determine the potential moderator effects of demographic (sex, age and educational level) and individual factors (cognitive reserve, general intelligence) with intervention-induced changes in cognitive and psychological well-being outcomes.

In addition, the Study 2 also has these objectives:

  • To generate the virtual environment of the designed interventions (HIFT-VR, Qigong-VR, and MBSR-VR).
  • To evaluate the usability, acceptability, and outcomes of the newly developed VR interventions in relation to cognitive and emotional health to explore the feasibility of each VR intervention.
  • To study the intervention-induced changes in the physical (physical activity and fitness status), mental (mindful thinking and sleep quality) and physiological stress (HRV) components and their potential mediator effect.
  • To compare effects and adherences of traditional versus VR-based interventions.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Severe Neurological or psychiatric history
  • Alcohol or drug abuse history
  • Injury that prevents exercise

Exclusion criteria

only for MRI examination:

  • Claustrophobia
  • Medical device (e.g., pacemaker implants, stents)
  • Other metal objects in the body

Exclusion criteria

only for VR study:

  • Dizziness
  • Contraindications or troubles that could condition the use of VR

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Changes in immediate verbal attention

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

    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.

  2. Changes in processing speed

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

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

  3. Changes in visual attention

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

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

  4. Changes in verbal memory

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

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

  5. Changes in visual memory

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

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

  6. Changes in Executive Function - Flexibility

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

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

  7. Changes in Executive Function - Inhibition

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

    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.

  8. Changes in Executive Function - Verbal Fluency

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

    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.

  9. Change in verbal digit working memory

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

    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.

  10. Changes in Verbal Comprehension

    Time frame: Baseline (2 weeks before)

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

  11. Changes in Psychological symptoms

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

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

  12. Changes in Self-esteem

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

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

  13. Changes in Depression, anxiety and stress

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

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

  14. Changes in Mindfulness

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

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

  15. Changes in Self-efficacy

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

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

  16. Changes in Sleep quality

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

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

  17. Changes in Diet

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

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

Secondary outcomes

  1. Changes in Physical activity

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

    International Physical Activity Questionnaire (IPAQ). Total physical activity measured in MET-min/week through the International Physical Activity Questionnaire - Short Form. Direct score. Higher scores indicate more physical activity.

  2. Changes in Anthropometric Measurements - Height

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

    Height in meters

  3. Changes in Anthropometric Measurements - Weight

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

    Weight in Kg

  4. Changes in Anthropometric Measurements - Body Mass

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

    Body mass index (BMI)

  5. Changes in Anthropometric Measurements - Waist and hip circumference

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

    Waist and hip circumference. Waist-to-hip ratio.

  6. Changes in Physiological stress - Heart rate variability

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

    RMSSD

  7. Changes in Physiological stress - blood pressure

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

    Blood pressure. Sistolic and diastolic blood pressure in millimeters of mercury.

  8. Changes in aerobic capacity

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

    Submaximal oxygen consumption test. Estimated VO2 score from submaximal step test.

  9. Changes in lower body muscle power

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

    Countermovement jump. Initial velocity and power output in countermovement jump in meters per second.

  10. Changes in strength of the hand flexor muscles

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

    Han-grip test. Right and left hand grip strength in kilogram-force.

  11. Changes in balance

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

    Y-balance test. Composite score of left leg Y Balance Test (% of leg length) (in cm). Formula = ((YBALANCE_L_ANTERIOR + YBALANCE_L_POSTEROMEDIAL + YBALANCE_L_POSTEROLATERAL) / (3 * LEG_LENGTH)) * 100

  12. Changes in flexibility

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

    Sit-and-reach test. Corrected sit and reach distance in centimeters.

  13. Changes in White matter integrity

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

    White matter integrity: tractography

  14. Changes in Resting-state connectivity

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

    Resting state brain activity using fMRI

  15. Changes in brain volumetry

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

    Grey and white matter volume measured by MRI

  16. Microbiota data

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

    Quantification of different bacterial species from the fresh stool samples

  17. Changes in emotional status

    Time frame: Follow-up (2 weeks after completing interventions)

    Semi-structured interview with qualitative content and sentiment analysis

  18. Usability Virtual Reality System:

    Time frame: Follow-up (2 weeks after completing interventions)

    System Usability Scale (SUS). Direct scores from 0 to 100. Higher scores indicate more usability

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Mataró, PhD

CONTACT

[email protected]

+34933125052

Samira Rostami, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Barcelona

Other

Collaborators

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

Registry information

Official study title

Active Young, Healthy Mind: Strategies for Brain Health and Psychological Well-being in Young Adults: A Randomized Mixed-method Study With and Without Virtual Reality (VR) (YoungFitT: Young Fitness Technology)

Acronym: YoungFitT

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 9, 2024
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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