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)

Overview

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.

Interventions

• 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.
• Behavioral 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.
• Behavioral 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.

Primary outcome measures

• Changes in immediate verbal attention [Time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)]
• Changes in processing speed [Time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)]
• Changes in visual attention [Time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)]
• Changes in verbal memory [Time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)]
• Changes in visual memory [Time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)]
• Changes in Executive Function - Flexibility [Time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)]
• Changes in Executive Function - Inhibition [Time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)]
• Changes in Executive Function - Verbal Fluency [Time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)]
• Change in verbal digit working memory [Time frame: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)]
• Changes in Verbal Comprehension [Time frame: Baseline (2 weeks before)]

Secondary outcome measures (12)

• 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)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Spain · 1 center

• Maria Mataro — Barcelona

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 i PMID 40748900

Identifiers

NCT: NCT06406283 · UB · PID2022-137776OB-100

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗