Meditation and Yoga for Irritable Bowel Syndrome Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- IBS-Symptom Severity Scale
研究概览
简要总结
Study Aim: This study will explore the feasibility and effectiveness of a yoga program for patients with IBS.
Methods: A superiority RCT with 30 participants per group. Adult patients with IBS fluent in English who do not have major physical impairments or cognitive, psychological, or psychiatric disorder will be recruited and randomly using the REDCap randomization module to either a yoga intervention delivered (a) a yoga intervention delivered online led by a yoga facilitator or (b) a advice only control group. The 8-week Hatha Yoga intervention consists of Yoga Namaskar, Nadi Shuddhi (alternate nostril breathing), mantra chanting, and breath watching.
Group 1: Yoga program. Participants will be asked to practice the yoga program daily at home and will be given access to the yoga videos hosted on the University of Calgary study website, as well as written program instructions, and frequently answered questions. A brief description of the video content will be provided to inform the participant of its content and length. Additional website content will include study information, study schedule, and contact information, as well as a pre-recorded educational session. In addition to the daily program describe above, the facilitator-led intervention will be delivered online by a certified yoga facilitator using the Microsoft Teams platform. Participants in group of 3 to 5 will be collated to enhance effectiveness of the study processes. Our team has experience with this approach, as this strategy is currently used with previous yoga study. Yoga classes will be held once per week for 8 weeks, with the first session lasting approximately 1.5 hours and subsequent sessions up to 60 minutes. The total allocated time for the introductory session will include the class set-up, introductions, educational material (please see below), overview of practices, teaching of practices, practice corrections/enhancements, modifications, and practice expectations. Each follow-up class will include review from the previous week, questions and answers, individual corrections and/or modifications. For individual corrections, the yoga facilitator will ask the participant to do the practices and receive corrections, if needed.
Group 2. Advice-only control group. This group will receive general education on IBS, the mind and gut connection, and the role of mind-body therapies in the management of IBS.
Effectiveness outcomes will be assessed at baseline and 8 weeks. The primary effectiveness outcome will be the severity of IBS symptoms, and secondary effectiveness outcomes include microbiome analysis, quality of life, anxiety and depression symptoms, perceived stress, fatigue, and severity of somatic symptoms. Microbiome composition will be measured using shotgun metagenomic sequencing. Microbiome sequences will be analyzed for alpha diversity, beta diversity, species composition, functional composition and biomarker discovery. To determine the feasibility of each intervention, recruitment and attrition rates, adherence, program preferences and satisfaction, and adverse event outcomes will be evaluated.
详细描述
Study Aim. This study will explore the feasibility and effectiveness of a yoga program for patients with IBS. Objective. Examine the feasibility and effectiveness of an 8-week online live facilitator-led yoga program compared to a wait-list control. Hypothesis. Yoga delivered online live by a facilitator will have the superior effectiveness in reducing IBS symptoms compared to advice only control group after 8 weeks.
Background
IBS is a highly prevalent disorder affecting 12% of Canadians. One in five individuals with IBS has one or more psychiatric disorder, and 50% have at least one comorbid somatic symptom. Frequently used therapies are targeted toward symptom reduction with modest benefits, whereas treatments with greater therapeutic effect may be associated with side effects. This leaves many patients dissatisfied with their symptom management, resulting in half of patients using alternative therapies. The underlying cause of IBS is likely multifactorial and the interplay of the brain-gut axis in the pathophysiology of IBS has been well established. An altered stress response, arising through either psychological and/or physiological mechanisms is hypothesized to be involved in the impairment of the signalling between the brain and the gut. This demonstrates a connection between gut function, stress, and psychological processes. Therefore, therapies that focus on mind-body interactions and stress reduction, may be useful adjunctive treatments for IBS.
Yoga is a traditional "mind-body-breath" discipline that includes yogic postures, structured breathing, and meditation. Several potential mechanisms for the effectiveness of yoga that have applicability to IBS have been proposed, including reducing the upregulated sympathetic activity and increasing the parasympathetic response. The investigator's recent review of the literature has identified four randomized controlled trials that examined traditional yoga practice as therapy for adult IBS patients. All trials found yoga as more effective compared to pharmacological treatment, and equally effective as dietary interventions or moderate-intensity walking. Both physical (IBS symptom severity, gastric motility, autonomic and somatic symptom scores, physical functioning) and mental (depression, anxiety, GI-specific anxiety, and QOL) improvements were seen. The current literature supports that yoga is effective, safe and it may target multiple mechanisms involved in the treatment of IBS symptoms as previously described. Although yoga is effective in managing IBS symptoms, further research is needed to determine the feasibility and effectiveness of yoga as a therapeutic option in clinical practice for patients with IBS, while also examining delivery strategies (face-to-face vs. online) to more optimally understand how to sequence therapeutic interventions and whether this improves initiation and adherence to the intervention.
Research Methods
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of IBS based on Rome IV criteria
- •At least 18 years old
- •Adequate understanding of English
- •Ability to provide written informed consent
- •No changes in IBS medication (including anti-depressants), diet, or physical activity levels for at least 8 weeks prior to starting the intervention
排除标准
- •Major physical impairment that would prevent the individual from doing yoga
- •Diagnosis of any major cognitive, psychological, or psychiatric disorder (diagnosed before or during the intervention) as identified by the treating physician/healthcare practitioner or screened by the study coordinator
结局指标
主要结局
IBS-Symptom Severity Scale
时间窗: Baseline and 8 weeks
Scores range from 0 to 500 with higher scores indicating more severe symptoms. Symptom reduction of at least 50 points is considered clinically meaningful; however, the primary endpoint will be the proportion of participants in each group who demonstrate a symptom reduction of 83 points or more, based on the variables used in the sample size calculation.
次要结局
- IBS-Quality of Life(Baseline and 8 weeks)
- Patient Health Questionnaire-15 (Somatic Symptoms)(Baseline and 8 weeks)
- COVID-19 Stress Scale(Baseline and 8 weeks)
- Attrition rates(8 weeks)
- Perceived Stress Scale(Baseline and 8 weeks)
- Recruitment rates(8 weeks)
- Adherence to class attendance and home practice(8 weeks)
- Generalized Anxiety Disorder(Baseline and 8 weeks)
- Patient Health Questionnaire-9 (Depression)(Baseline and 8 weeks)
- Modified Fatigue Impact Scale-21(Baseline and 8 weeks)
- Self-Compassion Scale-Short Form(Baseline and 8 weeks)
- Intention to practice yoga(Baseline and 8 weeks)
- Program preferences(Baseline)
- Program satisfaction(8 weeks)
- Adverse event outcomes(8 weeks)
研究者
Maitreyi Raman
Principal Investigator
University of Calgary