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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
219
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.
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.
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.
Maria Mataro
Barcelona, Spain
RECRUITINGChanges 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
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.
Time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Changes in Anthropometric Measurements - Height
Height in meters
Time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Changes in Anthropometric Measurements - Weight
Weight in Kg
Time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Changes in Anthropometric Measurements - Body Mass
Body mass index (BMI)
Time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Changes in Anthropometric Measurements - Waist and hip circumference
Waist and hip circumference. Waist-to-hip ratio.
Time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Changes in Physiological stress - Heart rate variability
RMSSD
Time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Changes in Physiological stress - blood pressure
Blood pressure. Sistolic and diastolic blood pressure in millimeters of mercury.
Time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Changes in aerobic capacity
Submaximal oxygen consumption test. Estimated VO2 score from submaximal step test.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Changes in lower body muscle power
Countermovement jump. Initial velocity and power output in countermovement jump in meters per second.
Time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Changes in strength of the hand flexor muscles
Han-grip test. Right and left hand grip strength in kilogram-force.
Time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
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
Time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Changes in flexibility
Sit-and-reach test. Corrected sit and reach distance in centimeters.
Time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Changes in White matter integrity
White matter integrity: tractography
Time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Changes in Resting-state connectivity
Resting state brain activity using fMRI
Time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Changes in brain volumetry
Grey and white matter volume measured by MRI
Time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Microbiota data
Quantification of different bacterial species from the fresh stool samples
Time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Changes in emotional status
Semi-structured interview with qualitative content and sentiment analysis
Time frame: Follow-up (2 weeks after completing interventions)
Usability Virtual Reality System:
System Usability Scale (SUS). Direct scores from 0 to 100. Higher scores indicate more usability
Time frame: Follow-up (2 weeks after completing interventions)