Clinical trial NCT06406283: Active Young, Healthy Mind. The YoungFitT Project
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: University Students
Keywords: Well-being
Physical exercise
Qigong
Mindfulness
Neuroimaging
Intervention
Randomization
Cognition
Virtual environment
Lead sponsor: University of Barcelona
Sponsor class: OTHER
Collaborators: name: University Ramon Llull
name: ICREA Academia
name: Institut de Neurociències de la Universitat de Barcelona
name: Institut de Recerca Sant Joan de Déu (CERCA center)
name: EventLab
name: INEFC
name: Nirakara Lab
name: Adventhealth Research Institute, Neuroscience
name: University of Murdock
First posted: 2024-05-09
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in immediate verbal attention
timeFrame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
measure: Changes in processing speed
timeFrame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
measure: Changes in visual attention
timeFrame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
measure: Changes in verbal memory
timeFrame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
measure: Changes in visual memory
timeFrame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
measure: Changes in Executive Function - Flexibility
timeFrame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
measure: Changes in Executive Function - Inhibition
timeFrame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
measure: Changes in Executive Function - Verbal Fluency
timeFrame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
measure: Change in verbal digit working memory
timeFrame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
measure: Changes in Verbal Comprehension
timeFrame: Baseline (2 weeks before)
measure: Changes in Psychological symptoms
timeFrame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
measure: Changes in Self-esteem
timeFrame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
measure: Changes in Depression, anxiety and stress
timeFrame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
measure: Changes in Mindfulness
timeFrame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
measure: Changes in Self-efficacy
timeFrame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
measure: Changes in Sleep quality
timeFrame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
measure: Changes in Diet
timeFrame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
Secondary outcomes:
measure: Changes in Physical activity
timeFrame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
measure: Changes in Anthropometric Measurements - Height
timeFrame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
measure: Changes in Anthropometric Measurements - Weight
timeFrame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
measure: Changes in Anthropometric Measurements - Body Mass
timeFrame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
measure: Changes in Anthropometric Measurements - Waist and hip circumference
timeFrame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
measure: Changes in Physiological stress - Heart rate variability
timeFrame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
measure: Changes in Physiological stress - blood pressure
timeFrame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
measure: Changes in aerobic capacity
timeFrame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
measure: Changes in lower body muscle power
timeFrame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
measure: Changes in strength of the hand flexor muscles
timeFrame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
measure: Changes in balance
timeFrame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
measure: Changes in flexibility
timeFrame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
measure: Changes in White matter integrity
timeFrame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
measure: Changes in Resting-state connectivity
timeFrame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
measure: Changes in brain volumetry
timeFrame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
measure: Microbiota data
timeFrame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)
measure: Changes in emotional status
timeFrame: Follow-up (2 weeks after completing interventions)
measure: Usability Virtual Reality System:
timeFrame: Follow-up (2 weeks after completing interventions)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Maria Mataro
Study officials:
affiliation: University of Barcelona
name: Maria Mataró, PhD
role: PRINCIPAL_INVESTIGATOR
References: