University StudentsYoungFitTNCT06406283
Active Young, Healthy Mind. The YoungFitT Project
A study testing High-Intensity Functional Training (HIFT), Mindfulness-Based Stress Reduction Program (MBSR) and Qigong in people with University Students, run by University of Barcelona at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- University Students
- What is being tested?
- High-Intensity Functional Training (HIFT), Mindfulness-Based Stress Reduction Program (MBSR) and Qigong
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 1 siteSpain
- Study dates
- 20 Dec 2023to 18 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Samira Rostami, PhD contact
Spain1 site, 1 recruiting
- Recruiting
Maria Mataro
Barcelona
Maria Mataro, PhD, +34933125052, mmataro@ub.edu
About this study
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)
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.
Read the detailed 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.
- Conditions
- University Students
- Being tested
- High-Intensity Functional Training (HIFT), Mindfulness-Based Stress Reduction Program (MBSR), Qigong
- Keywords
- Well-being, Physical exercise, Qigong, Mindfulness, Neuroimaging, Intervention, Randomization, Cognition, Virtual environment
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Functional Training (HIFT)Behavioural
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)Behavioural
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.
QigongBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| High-Intensity Functional Training (HIFT) Group | Experimental | Not described Receives: Behavioral: High-Intensity Functional Training (HIFT) |
| Mindfulness Group | Experimental | Not described Receives: Behavioral: Mindfulness-Based Stress Reduction Program (MBSR) |
| Qigong Group | Experimental | Not described Receives: Behavioral: Qigong |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Secondary outcomes (18)
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.
Measured: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Changes in Anthropometric Measurements - Height
Height in meters
Measured: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Changes in Anthropometric Measurements - Weight
Weight in Kg
Measured: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Changes in Anthropometric Measurements - Body Mass
Body mass index (BMI)
Measured: 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.
Measured: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Changes in Physiological stress - Heart rate variability
RMSSD
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Changes in White matter integrity
White matter integrity: tractography
Measured: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Changes in Resting-state connectivity
Resting state brain activity using fMRI
Measured: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Changes in brain volumetry
Grey and white matter volume measured by MRI
Measured: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Microbiota data
Quantification of different bacterial species from the fresh stool samples
Measured: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Changes in emotional status
Semi-structured interview with qualitative content and sentiment analysis
Measured: 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
Measured: Follow-up (2 weeks after completing interventions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start20 Dec 2023
- Primary completion18 May 2026 (estimated)
- Study completion18 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for University StudentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 219 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- University Ramon Llull, ICREA Academia, Institut de Neurociències de la Universitat de Barcelona, Institut de Recerca Sant Joan de Déu (CERCA center), EventLab, INEFC, Nirakara Lab, Adventhealth Research Institute, Neuroscience, University of Murdock
- Responsible party
- Principal investigator, Maria Mataro Serrat, University of Barcelona
- Investigators
- Maria Mataró, PhD, Principal investigator, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406283
- Sponsor's protocol ID
- UB
- Other IDs
- PID2022-137776OB-100
- Acronym
- YoungFitT
- Status last verified
- May 2024
- First submitted
- 10 Apr 2024
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40748900
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06406283
- Acronym / sponsor ID
- YoungFitT / UB
- Conditions
- University Students
- Keywords
- Well-being, Physical exercise, Qigong, Mindfulness, Neuroimaging, Intervention, Randomization, Cognition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 219 participants (estimated)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Collaborators
- University Ramon Llull, ICREA Academia, Institut de Neurociències de la Universitat de Barcelona, Institut de Recerca Sant Joan de Déu (CERCA center), EventLab, INEFC, Nirakara Lab, Adventhealth Research Institute, Neuroscience, University of Murdock
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 18 May 2026 (estimated)
- Study completion
- 18 Sep 2026 (estimated)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- Severe Neurological or psychiatric history
- Alcohol or drug abuse history
- Injury that prevents exercise
- Claustrophobia
- Medical device (e.g., pacemaker implants, stents)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | High-Intensity Functional Training (HIFT) Group |
| 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. | Behavioural | Mindfulness Group |
| QigongThis 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. | Behavioural | Qigong Group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
18 secondary outcomes
Changes in Physical activity
Time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Changes in Anthropometric Measurements - Height
Time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Changes in Anthropometric Measurements - Weight
Time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Changes in Anthropometric Measurements - Body Mass
Time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Changes in Anthropometric Measurements - Waist and hip circumference
Time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Changes in Physiological stress - Heart rate variability
Time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Changes in Physiological stress - blood pressure
Time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Changes in aerobic capacity
Time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Changes in lower body muscle power
Time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Changes in strength of the hand flexor muscles
Time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Changes in balance
Time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Changes in flexibility
Time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Changes in White matter integrity
Time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Changes in Resting-state connectivity
Time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Changes in brain volumetry
Time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Microbiota data
Time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Changes in emotional status
Time frame: Follow-up (2 weeks after completing interventions)
Usability Virtual Reality System:
Time frame: Follow-up (2 weeks after completing interventions)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Derived from this study: PubMed 40748900Rostami 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samira Rostami, PhD contact
Maria Mataró, PhD principal investigator
University of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Functional Training (HIFT), Mindfulness-Based Stress Reduction Program (MBSR) and Qigong in people with University Students, run by University of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Mataró, PhD (+34933125052, mmataro@ub.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in immediate verbal attention (time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06406283, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024; AzTrials last refreshed its copy on 28 Oct 2026.