Evaluating the Physiological and Psychological Impact of Low-Frequency Vibration Therapy: A Longitudinal Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Resting EEG Spectral Power
研究概览
简要总结
The goal of this randomized clinical trial is to learn whether a low-frequency "kinetic wellness" mat (a comfortable mat that gently vibrates) can improve stress recovery, sleep quality, mood, and attention in healthy adults ages 18-45.
The main questions it aims to answer are:
- After 3 weeks, does regular use of the vibrating mat increase heart rate variability (a noninvasive marker of the body's ability to recover from stress) and improve sleep, mood, perceived stress, and anxiety compared with no mat use?
- Do patterns of resting brain activity (measured with EEG) and heart rate variability (HRV) change from before to after the program, and are those changes related to each other?
Researchers will compare two groups: an Experimental group that uses the vibrating mat at home for 3 weeks, and a Control group that does not use the mat. Participants are randomly assigned to a group.
Participants will:
- Attend two lab visits (~60 min) for questionnaires, resting heart activity (HRV) and brain activity (EEG), and a brief attention test.
- On 3-4 days per week for 3 weeks:
- Experimental group: use the vibrating mat for 15 minutes while recording HRV.
- Control group: lie quietly for 15 minutes while recording HRV.
- Both groups: record HRV for 15 minutes before bedtime and 15 minutes after waking on those same days.
- Both groups: complete quick check-ins on feelings (after sessions and the next morning) and log caffeine/alcohol, exercise, and medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 18-45 years.
- •Able to provide written informed consent.
- •Apparently healthy and free of unstable cardiovascular, neurological, or psychiatric conditions per screening.
- •Cleared for low-to-moderate intensity whole-body vibration delivered supine/recumbent on a mat.
- •Willing and able to comply with study procedures: two lab visits; 3-week home protocol (3-4 days/week); three 15-min sessions; brief affect check-ins and daily logs.
- •Willing to abstain from caffeine, alcohol, and strenuous exercise for 24 hours before each lab visit and to attend visits at the same time of day.
- •Able to lie supine for 15 minutes and follow instructions for the HRV device.
排除标准
- •Implanted electronic medical devices (e.g., pacemaker, neurostimulator).
- •Uncontrolled hypertension or severe vestibular disorders.
- •Current substance dependence.
- •Medications known to markedly affect autonomic function or sleep architecture (e.g., beta-blockers, antiarrhythmics, sedative-hypnotics, antidepressants with strong autonomic effects).
- •Diagnosed neurological or psychological disorders that substantially affect emotional processing or autonomic regulation (severe psychiatric conditions).
- •Prior extensive experience with vibration therapies (to minimize expectancy bias).
- •Any condition judged by study staff to contraindicate vibration exposure or preclude safe participation (including inability to tolerate supine/recumbent position).
- •Unwillingness to refrain from initiating new structured exercise or relaxation programs during the study period.
结局指标
主要结局
Resting EEG Spectral Power
时间窗: From enrollment to the end of treatment at 3 weeks
Eyes-closed 15-minute, supine resting EEG using a 24-channel Smarting Mobi system. Preprocessing: 0.5-30 Hz band-pass, ocular SSP, ±100 µV artifact rejection, common-average reference; clean data segmented into 10-s epochs. Outcome is band power in Theta (4-8 Hz), Alpha (8-13 Hz), Beta (13-30 Hz), averaged across all electrodes and epochs (units: power; may be log-transformed for analysis). Higher values indicate stronger oscillatory activity in each band. Primary analysis compares Post-Baseline change between groups.
Resting EEG Directed Connectivity
时间窗: From enrollment to the end of treatment at 3 weeks
From the same 15-minute, eyes-closed, supine EEG. Frequency-domain Granger causality computed per 10-s epoch; spectra averaged within Theta (4-8 Hz), Alpha (8-13 Hz), Beta (13-30 Hz). Connectivity summarized across all electrodes via: (a) Global directed strength (mean of all non-diagonal influences; unitless; higher = stronger overall directed connectivity); (b) Nodal inflow and outflow (sum of incoming vs. outgoing influences for each electrode; unitless; higher = stronger received/sent influence); and (c) Pairwise directed influence (value for each electrode pair; unitless). Primary analysis compares Post-Baseline change between groups, with band-specific follow-ups.
Resting vagally mediated HRV
时间窗: From enrollment to the end of treatment at 3 weeks
Heart rate variability measured during a 15-minute, eyes-closed, supine rest in the lab. Inter-beat intervals captured with Optimal HRV; processed in Kubios (artifact correction; 4 Hz resampling; files with \>5% corrected beats excluded; spectral estimates with 300-s windows, 50% overlap). Outcomes reported as: * RMSSD (ms): Root mean square of successive differences. Higher = greater parasympathetic (vagal) activity. * HF power (0.15-0.40 Hz, ms²): High-frequency power. Higher = greater parasympathetic activity. Primary analysis compares change (Post - Baseline) between groups for each metric; an exploratory composite (mean of RMSSD and HF z-scores) may be reported to summarize parasympathetic tone.
Longitudinal HRV Response to Intervention
时间窗: Session days across Weeks 1-3
RMSSD and HF recorded (i) during the 15-min home session (vibration vs quiet rest), (ii) 15 min before bedtime, and (iii) 15 min after waking. Outcomes are trajectories and group differences over time (linear mixed-effects). Benefit onset (threshold) will be explored via segmented regression/GAM change-point. Operational definition (pre-specified exploratory): first of two consecutive session-day recordings where RMSSD exceeds each participant's Baseline median by ≥0.10 log-units (\~10% increase), sustained thereafter.
次要结局
- Sleep Quality (PSQI Global Score)(From enrollment to the end of treatment at 3 weeks)
- Perceived Stress (PSQ Total Score)(From enrollment to the end of treatment at 3 weeks)
- State Anxiety (6-Item STAI Short Form)(From enrollment to the end of treatment at 3 weeks)
- Mood States (Brunel Mood Scale)(From enrollment to the end of treatment at 3 weeks)
- Cognitive Test (Trail Making Test)(From enrollment to the end of treatment at 3 weeks)