Exercise and Nutrition as Treatment Alternatives in Women With Inflammatory Bowel Disease During Preconception: Saskatchewan Multidisciplinary Inflammatory Bowel Diseases Clinic (MDIBDC)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Change from Baseline Inflammatory Bowel Disease Questionnaire score
研究概览
简要总结
The objectives are to: 1) Assess the independent and synergistic efficacy of exercise and nutrition interventions to manage major symptomatic concerns of inflammatory bowel diseases (IBD), 2) Assess the independent and synergistic efficacy of exercise and nutrition to mitigate inflammation in IBD, and 3) Assess the feasibility of such an intervention in preconception women with IBD. The investigators hypothesize that the combination of anti-inflammatory exercise and nutritional interventions will have a synergistic effect on managing major symptomatic concerns associated with IBD, reducing inflammation, and improving fertility status in preconception women with IBD, as compared to either intervention independently.
详细描述
Potential participants will be recruited from the Preconception and Pregnancy Clinic recently established within the Saskatchewan Multidisciplinary Inflammatory Bowel Disease Clinic [MDIBDC]. Eligible participants will be randomized [stratified] to one of four groups: 1) Exercise and dietary plan, 2) Exercise and no dietary plan, 3) Stretching [placebo exercise] and dietary plan, 4) Stretching and no dietary plan. Participants will be assessed at baseline, midway [3 months], and post-intervention [6 months] for indications of disease activity, quality of life, fertility status, and bone health.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of Inflammatory Bowel Disease
- •Child-bearing age
排除标准
- •Currently following a Mediterranean diet
- •Currently performing resistance training on a regular basis (within the past 6 months)
- •Failed Physical Activity Readiness Questionnaire-Plus (PAR-Q+).
- •Past ileal pouch anal anastomosis
- •Unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise subject safety
研究组 & 干预措施
Exercise and dietary plan
Combination cardiovascular and resistance training and Mediterranean dietary plan
干预措施: Exercise (Other)
Exercise and dietary plan
Combination cardiovascular and resistance training and Mediterranean dietary plan
干预措施: Dietary plan (Other)
Exercise and no dietary plan
Combination cardiovascular and resistance training and participants regular diet (control diet)
干预措施: Exercise (Other)
Stretching and dietary plan
Flexibility training (control exercise) and Mediterranean dietary plan
干预措施: Dietary plan (Other)
Stretching and dietary plan
Flexibility training (control exercise) and Mediterranean dietary plan
干预措施: Stretching (Other)
Stretching and no dietary plan
Flexibility training (control exercise) and participants regular diet (control diet)
干预措施: Stretching (Other)
结局指标
主要结局
Change from Baseline Inflammatory Bowel Disease Questionnaire score
时间窗: Baseline, 3 months, and 6 months
Inflammatory Bowel Disease Questionnaire (score on a scale); measures quality of life
次要结局
- Change from Baseline in Body Composition(Baseline, 3 months, and 6 months)
- Change from Baseline in Femoral Neck Bone Mineral Density(Baseline, 3 months, and 6 months)
- Change from Baseline Protein Consumption(Baseline, 3 months, and 6 months)
- Change from Baseline in Estradiol(Baseline, 3 months, and 6 months)
- Change from Baseline in Harvey Bradshaw Index(Baseline, 3 months, and 6 months)
- Change from Baseline Fat Consumption(Baseline, 3 months, and 6 months)
- Change from Baseline Interleukin-6(Baseline, 3 months, and 6 months)
- Change from Baseline in Follicle Stimulating Hormone(Baseline, 3 months, and 6 months)
- Change from Baseline in Leisure Time Physical Activity Questionnaire score(Baseline, 3 months, and 6 months)
- Change from Baseline in Total Body Lean Mass(Baseline, 3 months, and 6 months)
- Change from Baseline in Total Body Fat Mass(Baseline, 3 months, and 6 months)
- Change from Baseline Fecal Calprotectin(Baseline, 3 months, and 6 months)
- Change from Baseline Carbohydrate Consumption(Baseline, 3 months, and 6 months)
- Change from Baseline EuroQol Five Dimensions Questionnaire (EQ-5D) score(Baseline, 3 months, and 6 months)
- Change from Baseline in Total Body Bone Mineral Density(Baseline, 3 months, and 6 months)
- Change from Baseline in partial Mayo Score(Baseline, 3 months, and 6 months)
研究者
Sharyle Fowler
M.D.
University of Saskatchewan