Active Young, Healthy Mind. The YoungFitT Project

Официальное название

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)

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

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

Вторичные конечные точки (12)

• Changes in Physical activity [Срок оценки: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)]
• Changes in Anthropometric Measurements - Height [Срок оценки: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)]
• Changes in Anthropometric Measurements - Weight [Срок оценки: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)]
• Changes in Anthropometric Measurements - Body Mass [Срок оценки: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)]
• Changes in Anthropometric Measurements - Waist and hip circumference [Срок оценки: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)]
• Changes in Physiological stress - Heart rate variability [Срок оценки: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)]
• Changes in Physiological stress - blood pressure [Срок оценки: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)]
• Changes in aerobic capacity [Срок оценки: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)]
• Changes in lower body muscle power [Срок оценки: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)]
• Changes in strength of the hand flexor muscles [Срок оценки: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)]
• Changes in balance [Срок оценки: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)]
• Changes in flexibility [Срок оценки: Baseline (2 weeks before) & follow-up (2 weeks after completing interventions)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Maria Mataro — Barcelona

Публикации

• 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

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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