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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 219
- 试验地点
- 1
- 主要终点
- Changes in Executive Function - Flexibility
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Changes in Executive Function - Flexibility
时间窗: 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 visual attention
时间窗: 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
时间窗: 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 processing speed
时间窗: 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 immediate verbal attention
时间窗: 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 Depression, anxiety and stress
时间窗: 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 visual memory
时间窗: 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 - Inhibition
时间窗: 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
时间窗: 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.
Changes in Self-esteem
时间窗: 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.
Change in verbal digit working memory
时间窗: 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
时间窗: 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
时间窗: 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 Mindfulness
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Changes in Anthropometric Measurements - Height(Baseline (2 weeks before) & follow-up (2 weeks after completing interventions))
- Changes in Anthropometric Measurements - Body Mass(Baseline (2 weeks before) & follow-up (2 weeks after completing interventions))
- Changes in Physiological stress - blood pressure(Baseline (2 weeks before) & follow-up (2 weeks after completing interventions))
- Changes in lower body muscle power(Baseline (2 weeks before) & follow-up (2 weeks after completing interventions))
- Changes in strength of the hand flexor muscles(Baseline (2 weeks before) & follow-up (2 weeks after completing interventions))
- Microbiota data(Baseline (2 weeks before) & follow-up (2 weeks after completing interventions))
- Changes in Anthropometric Measurements - Waist and hip circumference(Baseline (2 weeks before) & follow-up (2 weeks after completing interventions))
- Changes in Physiological stress - Heart rate variability(Baseline (2 weeks before) & follow-up (2 weeks after completing interventions))
- Changes in brain volumetry(Baseline (2 weeks before) & follow-up (2 weeks after completing interventions))
- Changes in Physical activity(Baseline (2 weeks before) & follow-up (2 weeks after completing interventions))
- Changes in Anthropometric Measurements - Weight(Baseline (2 weeks before) & follow-up (2 weeks after completing interventions))
- Changes in aerobic capacity(Baseline (2 weeks before) & follow-up (2 weeks after completing interventions))
- Changes in flexibility(Baseline (2 weeks before) & follow-up (2 weeks after completing interventions))
- Changes in Resting-state connectivity(Baseline (2 weeks before) & follow-up (2 weeks after completing interventions))
- Changes in White matter integrity(Baseline (2 weeks before) & follow-up (2 weeks after completing interventions))
- Changes in emotional status(Follow-up (2 weeks after completing interventions))
- Usability Virtual Reality System:(Follow-up (2 weeks after completing interventions))
- Changes in balance(Baseline (2 weeks before) & follow-up (2 weeks after completing interventions))
研究者
Maria Mataro Serrat
Principal Investigator
University of Barcelona