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临床试验/NCT03520244
NCT03520244已完成不适用

Understanding the Relationship Between the MicrobiOme, Vitality and Exercise in Celiac Disease (MOVE-C)

University of Calgary2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2016年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
2
主要终点
Celiac Disease Quality of Life (CD-QoL)

研究概览

简要总结

Engagement in regular physical activity (PA) is associated with a range of physical and psychological benefits among chronic disease populations. Celiac disease is a chronic autoimmune condition that requires strict adherence to a gluten-free diet (GFD) for the best medical outcomes, as well as to prevent detrimental health outcomes including bloating, diarrhea, constipation, and increased risk of intestinal cancers and osteoporosis. Despite following a GFD, individuals with celiac disease often report dissatisfaction with the diet, are less likely to engage in social activities, can have an imbalance in gut bacteria and up to 30% still report negative symptoms (e.g., gastro-intestinal upset). Furthermore, preliminary research revealed that rates of PA among those with celiac disease are dismal, with the majority of participants failing to engage in regular PA. The purpose of this pilot research project is to examine the effects of a 12-week structured exercise program on inactive adults with celiac disease. It is anticipated that compared to those in a wait-list control condition, participants who engage in the 12-week exercise program will report greater improvements in quality of life and experience improved balance of gut bacteria. The findings from this project may reveal an additional strategy to optimize health while living with celiac disease. In addition, results from this study will provide essential pilot data that will inform a grant application for a larger clinical trial to further investigate the role of exercise in the promotion of health and well-being among those with celiac disease.

详细描述

Background & Rationale:

Engagement in regular physical activity (PA) is associated with a range of physical and psychological benefits among chronic disease populations. Quality of life (QoL) is significantly higher among people with cancer, depression and coronary heart disease who engage in PA on a regular basis. Risk of other chronic diseases such as type 2 diabetes is significantly reduced when people engage in regular PA. In addition, findings from a recent intervention study revealed that after engaging in a 12-week structured exercise program, cancer survivors had improvements in physical functioning, and reductions in fatigue and tiredness.

One chronic disease population that could particularly benefit from engaging in regular PA is people with celiac disease. Celiac disease is a chronic autoimmune condition and the incidence has increased 4 to 5 times over the past 50 years. Strict adherence to a gluten-free diet (GFD) is currently the only treatment for preventing both short- and long-term consequences from celiac disease (e.g., infertility, intestinal cancers, osteoporosis). Unfortunately, preliminary research revealed that rates of PA among those with celiac disease are dismal, with the majority of participants failing to engage in regular PA. Further, following a strict GFD alone may not be sufficient to effectively manage the disease, and can be associated with detrimental outcomes including reduced QoL. Despite following a GFD, individuals with celiac disease report high treatment burden, lower social engagement, fatigue, altered gut microbiota, and up to 30% still report negative symptoms (e.g., gastro-intestinal upset). Given the benefits of engagement in regular PA for other chronic disease populations, helping people with celiac disease become more physically active may lead to improvements in QoL and physiological outcomes.

High-Intensity Interval Training (HIIT) has been found to be appropriate for those with lifestyle-induced chronic diseases, including type 2 diabetes, atherosclerotic cardiovascular disease and metabolic syndrome. HIIT involves repeated bouts of high intensity effort followed by varied recovery times and can be easily modified for people of all fitness levels and chronic conditions. For example, Jung and colleagues reported on the benefits of HIIT for people with pre-diabetes and found that compared to participants engaging in moderate intensity continuous training, participants who engaged in regular bouts of HIIT exercise had better adherence to independent exercise. Martinez et al. found that participants who engaged in shorter interval training (e.g., HIIT), reported more pleasure and enjoyment of the exercise when compared to heavy, continuous or longer interval exercise. In addition to improvements in behavioural outcomes, Denou and colleagues recently found that HIIT also led to improvements in the gut microbiota of mice with diet induced obesity. Given that people with celiac disease are at increased risk of metabolic syndrome and are likely to have gut dysbiosis (imbalance in gut microorganisms), it is anticipated that HIIT may lead to improvements in key psychosocial (e.g., QoL) and behavioural outcomes (i.e., exercise adherence). Further, key markers of metabolic syndrome and balance in the gut microbiota may be positively impacted.

Study aims:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

Outcomes assessors are masked to participant group.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years+, diagnosed with celiac disease (blood test and/or biopsy), lives in the Calgary area, inactive (engage in exercise on 2 or less days of the week for 30 mins or less)

排除标准

  • medical condition preventing engagement in progressive high intensity interval training, unable to attend exercise sessions at the University 2x/week for 12 weeks

结局指标

主要结局

Celiac Disease Quality of Life (CD-QoL)

时间窗: Baseline, Immediately Post Program and 3 Months After Program

Assessment of change in Celiac Disease Quality of Life (CD-QoL)

Microbiome

时间窗: Baseline, Immediately Post Program and 3 Months After Program

Assessment of change in balance of gut microbiome assessed through stool samples analysis

次要结局

  • Sleep quality(Baseline, Immediately Post Program and 3 Months After Program)
  • Self-regulatory efficacy - gluten-free diet(Baseline, Immediately Post Program and 3 Months After Program)
  • Serum lipids(Baseline, Immediately Post Program and 3 Months After Program)
  • Adherence to a Gluten-free Diet(Baseline, Immediately Post Program and 3 Months After Program)
  • Gastrointestinal symptoms(Baseline, Immediately Post Program and 3 Months After Program)
  • Fasting glucose(Baseline, Immediately Post Program and 3 Months After Program)
  • Blood pressure(Baseline, Immediately Post Program and 3 Months After Program)
  • Exercise behaviour(Baseline, Immediately Post Program and 3 Months After Program)
  • Self-regulatory efficacy - exercise(Baseline, Immediately Post Program and 3 Months After Program)
  • Self-compassion - Short form(Baseline, Immediately Post Program and 3 Months After Program)
  • Waist circumference(Baseline, Immediately Post Program and 3 Months After Program)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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