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| ID | Type | Description | Link |
|---|---|---|---|
| PID2022-137776OB-100 | Other Grant/Funding Number | Ministerio de Ciencia e Innovación (Gobierno de España)] |
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| Name | Class |
|---|---|
| University Ramon Llull | OTHER |
| ICREA Academia | UNKNOWN |
| Institut de Neurociències de la Universitat de Barcelona | UNKNOWN |
| Institut de Recerca Sant Joan de Déu (CERCA center) |
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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:
In addition, the Study 2 also has these objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Intensity Functional Training (HIFT) Group | Experimental |
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| Mindfulness Group | Experimental |
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| Qigong Group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria only for MRI examination:
Exclusion criteria only for VR study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Mataró, PhD | Contact | +34933125052 | mmataro@ub.edu | |
| Samira Rostami, PhD | Contact | Samira7rostami@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Maria Mataró, PhD | University of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maria Mataro | Recruiting | Barcelona | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40748900 | Derived | 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. |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D064906 | Qigong |
| ID | Term |
|---|---|
| D001945 | Breathing Exercises |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| UNKNOWN |
| EventLab | UNKNOWN |
| INEFC | UNKNOWN |
| Nirakara Lab | INDUSTRY |
| Adventhealth Research Institute, Neuroscience | UNKNOWN |
| University of Murdock | UNKNOWN |
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.
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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.
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| 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. |
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| 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. |
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| 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) |
| Changes in Anthropometric Measurements - Height | Height in meters | Baseline (2 weeks before) & follow-up (2 weeks after completing interventions) |
| Changes in Anthropometric Measurements - Weight | Weight in Kg | Baseline (2 weeks before) & follow-up (2 weeks after completing interventions) |
| Changes in Anthropometric Measurements - Body Mass | Body mass index (BMI) | 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. | Baseline (2 weeks before) & follow-up (2 weeks after completing interventions) |
| Changes in Physiological stress - Heart rate variability | RMSSD | 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. | 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. | 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. | 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. | 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 | 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. | Baseline (2 weeks before) & follow-up (2 weeks after completing interventions) |
| Changes in White matter integrity | White matter integrity: tractography | Baseline (2 weeks before) & follow-up (2 weeks after completing interventions) |
| Changes in Resting-state connectivity | Resting state brain activity using fMRI | Baseline (2 weeks before) & follow-up (2 weeks after completing interventions) |
| Changes in brain volumetry | Grey and white matter volume measured by MRI | Baseline (2 weeks before) & follow-up (2 weeks after completing interventions) |
| Microbiota data | Quantification of different bacterial species from the fresh stool samples | Baseline (2 weeks before) & follow-up (2 weeks after completing interventions) |
| Changes in emotional status | Semi-structured interview with qualitative content and sentiment analysis | 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 | Follow-up (2 weeks after completing interventions) |
| D026241 |
| Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |