Active Young, Healthy Mind. The YoungFitT Project

University Students Clinical Trial

— YoungFitT  

Official 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06406283
• Other study ID #: UB
• Secondary ID: PID2022-137776OB
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2023
• Est. completion date: September 18, 2026

Study information

• Verified date: May 2024
• Source: University of Barcelona
• Contact: Maria Mataró, PhD
• Phone: +34933125052
• Email: mmataro[@]ub.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 219
• Est. completion date: September 18, 2026
• Est. primary completion date: May 18, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• University Students

Intervention

Behavioral:
• High-Intensity Functional Training (HIFT)
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)
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
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.

Locations

Country	Name	City	State
Spain	Maria Mataro	Barcelona

Sponsors (10)

Lead Sponsor	Collaborator
University of Barcelona	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 of Murdock, University Ramon Llull

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Changes in Physical activity	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.	Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Secondary	Changes in Anthropometric Measurements - Height	Height in meters	Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Secondary	Changes in Anthropometric Measurements - Weight	Weight in Kg	Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Secondary	Changes in Anthropometric Measurements - Body Mass	Body mass index (BMI)	Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Secondary	Changes in Anthropometric Measurements - Waist and hip circumference	Waist and hip circumference. Waist-to-hip ratio.	Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Secondary	Changes in Physiological stress - Heart rate variability	RMSSD	Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Secondary	Changes in Physiological stress - blood pressure	Blood pressure. Sistolic and diastolic blood pressure in millimeters of mercury.	Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Secondary	Changes in aerobic capacity	Submaximal oxygen consumption test. Estimated VO2 score from submaximal step test.	Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Secondary	Changes in lower body muscle power	Countermovement jump. Initial velocity and power output in countermovement jump in meters per second.	Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Secondary	Changes in strength of the hand flexor muscles	Han-grip test. Right and left hand grip strength in kilogram-force.	Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Secondary	Changes in balance	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	Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Secondary	Changes in flexibility	Sit-and-reach test. Corrected sit and reach distance in centimeters.	Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Secondary	Changes in White matter integrity	White matter integrity: tractography	Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Secondary	Changes in Resting-state connectivity	Resting state brain activity using fMRI	Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Secondary	Changes in brain volumetry	Grey and white matter volume measured by MRI	Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Secondary	Microbiota data	Quantification of different bacterial species from the fresh stool samples	Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Secondary	Changes in emotional status	Semi-structured interview with qualitative content and sentiment analysis	Follow-up (2 weeks after completing interventions)
Secondary	Usability Virtual Reality System:	System Usability Scale (SUS). Direct scores from 0 to 100. Higher scores indicate more usability	Follow-up (2 weeks after completing interventions)