The ExMET-IBD Study: A Randomized Control Trial to Determine the Effects of Exercise on Intestinal Microbiota and Immunological Markers in Patients With Inflammatory Bowel Disease and Rheumatoid Arthritis
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Body composition alterations in patients with exercise.
研究概览
简要总结
The purpose of this study is too determine the effects of exercise on the gut microbiota and immunological markers in patients with inflammatory bowel disease and rheumatoid arthritis.
详细描述
Background:
The benefits of exercise are plentiful (1). They are physical, psychological and social. Exercise exhibits its effects on multiple systems through multiple mechanisms. These mechanisms are often poorly understood. Long-term resistance training results in many health benefits. It is associated with a reduced risk of low-grade inflammatory diseases, improved metabolic profile in patients with type two diabetes and the prevention of osteoporosis (2, 3). The means by which resistance training achieves this is not fully understood. A study of paediatric patients with Inflammatory Bowel Disease found that this patient cohort tolerated high intensity exercise well (4). Regular exercise could help improve disease activity in Inflammatory Bowel Disease by the release of anti-inflammatory cytokines from myocytes during exercise.
Intestinal microbiota are now thought to be a key link in disease expression in humans (5). Previous studies have shown that aerobic exercise in obese adolescents has led to particular alterations in intestinal microbiota (6). These alterations appear to be related to the weight loss experienced. This may determine the quantity of weight and body fat lost by these adolescents.
Persistent resistance and aerobic exercise also leads to changes in baseline immunological profiles, particularly cytokines (7).
The investigators aim to explore the relationship between alterations in intestinal microbiota following a structured mixed cardio-respiratory and strength training exercise program and the correlation with changes on cytokine profile, percentage of body fat lost and disease activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 - 40 year-old male and females
- •BMI between 22 and 35
- •Confirmed diagnosis of Crohn's Disease, Ulcerative Colitis or Rheumatoid Arthritis
- •Currently inactive i.e. No involvement in regular organized physical activity and with low weekly physical activity levels - as defined by the International Physical Activity Questionnaire (IPAQ)
- •No regular organized physical activity in the last month
- •Subject is willing to comply thoroughly with the basic, standard requirements of the training program
- •Subject is willing to refrain from taking any unspecified dietary, probiotics, multivitamin or herbal supplements (14-day washout period pre-commencement of exercise program)
- •Participant is happy to confine their formal exercise to within the Mardyke Arena
- •Deemed to be fit to participate in exercise program for 8 weeks by the study investigators
排除标准
- •History of coronary artery disease, congenital heart disease or any cardiovascular disease, including a family history of coronary artery disease before 45 years of age
- •Uncontrolled hypertension (>140/90mmHg) (not white coat)
- •Course of antibiotics or bowel preparation for endoscopy one month prior to the commencement of the exercise program
- •Psychiatric disorders
- •Any medical condition deemed exclusionary by the Principle Investigator
- •A history of substance abuse
- •History of total colectomy
- •Currently treated with high dose corticosteroids or disease flare within 2 weeks of starting exercise program
- •History of faecal incontinence
- •Have a malignant disease or any concomitant end stage organ disease
- •Patients may not be receiving any experimental drug or have been involved in a recent experimental trial in the last 30 days
研究组 & 干预措施
Immediate exercise
This group will immediately commence an 8 week exercise programme.
干预措施: Exercise (Other)
Delayed exercise
This group will continue regular activities for 8 weeks and then commence 8 week exercise programme.
干预措施: Exercise (Other)
结局指标
主要结局
Body composition alterations in patients with exercise.
时间窗: 8 weeks
To determine the metabolic and body composition alterations that occur in these patients with exercise as measured by changes in body fat composition measured using DEXA imaging and relate these changes to microbiota change
次要结局
- Changes in Powell tuck score in subjects with ulcerative colitis(8 weeks)
- Changes in DAS-28 CRP score in subjects with rheumatoid arthritis(8 weeks)
- Changes in Predicted VO2 max via 1-mile walk test (Rockport test)(8 weeks)
- Changes in fecal bile acids(8 weeks)
- Impact of medium-term moderate intensity exercise on resting inflammatory profiles (cytokines) in these patients.(8 weeks)
- Changes in Harvey Bradshaw index in subjects with Crohn's disease(8 weeks)
- Changes in markers of intestinal inflammation (faecal calprotectin) that occur with exercise(8 weeks)
- Alterations in gut microbiota(8 weeks)
研究者
Professor Fergus Shanahan
Professor and Chair Department of Medicine and Director Alimentary Pharmabiotic Centre, University College Cork
University College Cork