Sinclair Jonathan, Brooks-Warburton Johanne, Baker Lauren, Pujari Amit N, Jewiss Matthew, Lawson Charlotte, Anderson Simon, Bottoms Lindsay
Research Centre for Applied Sport, Physical Activity and Performance, School of Sport and Health Sciences, Faculty of Allied Health and Wellbeing, University of Central Lancashire, Preston, Lancashire, United Kingdom.
Centre for Research in Psychology and Sports, School of Life and Medical Sciences, University of Hertfordshire, Hatfield, Hertfordshire, United Kingdom.
PLoS One. 2025 Mar 19;20(3):e0319685. doi: 10.1371/journal.pone.0319685. eCollection 2025.
Crohn's disease (CD) is a long-term inflammatory gastrointestinal disorder, often adversely affecting physical, emotional, and psychological well-being. Pharmaceutical management is habitually adopted; although medicinal therapies require continuous administration, and are often associated with significant side effects and low adherence rates. Whole body vibration (WBV) represents a non-invasive technique, that provides vibration stimulation to the entire body. As WBV appears to target the physiological pathways and symptoms pertinent to CD epidemiology, it may have significant potential as a novel non-pharmaceutical intervention therapy in CD. This paper presents the study protocol for a randomised controlled trial investigating the impact of WBV on health outcomes in individuals with CD. This 6-week, parallel randomised controlled trial will recruit 168 individuals, assigned to receive WBV and lifestyle education 3 times per week compared to control, receiving lifestyle education only. The primary outcome of the trial will be the difference from baseline to post-intervention in health-related quality of life between the groups, assessed with the Inflammatory Bowel Disease Quality of Life Questionnaire. Secondary outcomes will include between-group differences in other questionnaires assessing fatigue, anxiety and pain, measures of physical fitness, and biological markers for disease activity and inflammation. Statistical analyses will follow an intention-to-treat approach, using linear mixed-effects models to compare changes between time points and both trial groups. Ethical approval was granted by the Nottingham Research Ethics Committee (REC: 24/EM/0106) and the study has been registered prospectively as a clinical trial (NTC06211400).
克罗恩病（CD）是一种长期的炎症性胃肠道疾病，常对身体、情绪和心理健康产生不利影响。通常采用药物治疗；尽管药物疗法需要持续给药，且常常伴有显著的副作用和低依从率。全身振动（WBV）是一种非侵入性技术，可对全身提供振动刺激。由于WBV似乎针对与CD流行病学相关的生理途径和症状，它可能作为一种治疗CD的新型非药物干预疗法具有巨大潜力。本文介绍了一项随机对照试验的研究方案，该试验旨在研究WBV对CD患者健康结局的影响。这项为期6周的平行随机对照试验将招募168名个体，分为两组，一组每周接受3次WBV和生活方式教育，另一组作为对照，仅接受生活方式教育。试验的主要结局将是两组之间从基线到干预后与健康相关的生活质量的差异，使用炎症性肠病生活质量问卷进行评估。次要结局将包括在评估疲劳、焦虑和疼痛的其他问卷、体能指标以及疾病活动和炎症的生物标志物方面的组间差异。统计分析将采用意向性分析方法，使用线性混合效应模型比较各时间点和两个试验组之间的变化。该研究已获得诺丁汉研究伦理委员会的伦理批准（REC：24/EM/0106），并已作为一项临床试验进行前瞻性注册（NTC06211400）。
