Benefit of Moderate Intensity Exercise in Patients With Clinical Quiescent Inflammatory Bowel Disease (IBDEXERCISE)
2026年8月18日 更新者：Mahidol University
The goal of this Randomised controlled trial is to investigate the effect of exercise on changes in quality of life in in patients with clinical quiescent Inflammatory bowel Disease. The main question it aims to answer
- The Relationship Between Moderate-Intensity Exercise and Quality of Life in Patients with clinical quiescent nflammatory Bowel Disease Over a Six-Month Period
- To examine the association between the recurrence of clinical symptoms(defined as a Harvey-Bradshaw Index > 5 for Crohn's disease and a Mayo Ulcerative Colitis Subscore > 2 for Ulcerative Colitis) and changes in inflammatory markers in blood and stool, comparing patients with clinical quiescent inflammatory bowel disease (IBD) who engage in regular exercise versus those who do not.
- To evaluate the relationship between higher levels of physical activity and quality of life, sleep quality, and stress levels in patients with clinical quiescent IBD.
- To assess changes in body composition including body mass index (BMI), fat mass, total muscle mass, skeletal muscle mass, and skeletal muscle index between patients who exercise regularly and those who do not.
Intervened participants will be encoraged in moderate-intensity exercise for at least 30 minutes per session, three times per week or more, under the supervision and guidance of a sports scientist compared participants who do not receive exercise training or supervision from a sports scientist.
研究概览
研究类型
介入性
注册 (估计的)
50
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Jirateep Tuntichamnankul, MD
- 电话号码：+66 0858570247
- 邮箱：jirateeptuntikul2@gmail.com
研究联系人备份
- 姓名：Julajak Limsrivilai, MD, MSc
- 电话号码：+66 081-496-8895
- 邮箱：alimsrivilai@gmail.com
学习地点
-
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Bangkok
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Bangkok Noi、Bangkok、泰国、10700
- 招聘中
- Faculty of Medicine Siriraj Hospital
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接触：
- Jirateep Tuntichamnankul, MD
- 电话号码：+66 0858570247
- 邮箱：jirateeptuntikul2@gmail.com
-
接触：
- Julajak Limsrivilai, MD, MSc
- 电话号码：+66 081-496-8895
- 邮箱：alimsrivilai@gmail.com
-
副研究员：
- Marianee Salaemae, BD
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Patients diagnosed with Crohn's disease or Ulcerative colitis.
- Aged between 18 and 65 years.
- Disease must be in clinical remission for at least 2 months prior to study enrollment, as defined by: Crohn's disease: Harvey-Bradshaw Index < 5 Ulcerative colitis: Mayo Ulcerative Colitis Subscore < 2
- Not currently receiving corticosteroids,
- If receiving immunomodulators or biologic therapy, the treatment regimen must be stable for at least 2 months prior to enrollment.
- Participants must have access to and be capable of using online communication tools and digital platforms.
Exclusion Criteria:
- Patients with medical conditions that limit the ability to exercise, including Severe joint pain or inflammatory arthritis affecting ambulation or mobility Advanced cardiac disease (New York Heart Association Class ≥ 2) Chronic lung disease or pulmonary hypertension Liver cirrhosis Chronic kidney disease stage 3 or higher
Poorly controlled non-communicable diseases, such as:
Hypertension (BP ≥ 160/100 mmHg) Diabetes mellitus with poor glycemic control (HbA1c ≥ 9% or requiring insulin therapy)
- Patients who already engage in moderate-intensity exercise for more than 60 minutes per week on a regular basis.
- Pregnant individuals or those planning to become pregnant during the study period.
- Patients planning to undergo treatment changes or surgery within the next 3 months, or who have had surgery within the past 6 months.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：patients with clinical quiescent Inflammatory bowel Disease taught exercise by sport scientist
Patient will be encouraged in moderate-intensity exercise for at least 30 minutes per session, three times per week or more, under the supervision and guidance of a sports scientist.
to look for improvement of IPAQ score
|
Patient will be encouraged in moderate-intensity exercise for at least 30 minutes per session, three times per week or more, under the supervision and guidance of a sports scientist.
To look for improvement of IPAQ score
|
|
无干预：Non exercise patient
Participants with clinical quiescent Inflammatory bowel Disease who do not receive exercise training or supervision from a sports scientist.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
大体时间：6 months
|
•Short Inflammatory Bowel Disease Questionnaire (SIBDQ) total score at 6 months. - Total score ranges from 10 to 70. Higher scores indicate better health-related quality of life. |
6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Harvey-Bradshaw Index (HBI)
大体时间：6 months
|
Clinical relapse assessed at 6 months. - Relapse is defined as Harvey-Bradshaw Index (HBI) >5 for Crohn's disease |
6 months
|
|
Mayo Ulcerative Colitis Subscore
大体时间：6 months
|
Clinical relapse is defined by Mayo Ulcerative Colitis Subscore >2 for ulcerative colitis.
|
6 months
|
|
Pittsburgh Sleep Quality Index (PSQI)
大体时间：6 months
|
Pittsburgh Sleep Quality Index (PSQI) total score.
if overall score <= 5 : good quality of sleep if Overall score >5 : poor quality of sleep
|
6 months
|
|
Body mass index (BMI)
大体时间：6 months
|
BMI is expressed in kg/m²
|
6 months
|
|
Skeletal muscle mass
大体时间：6 months
|
Skeletal muscle mass is expressed in kg
|
6 months
|
|
Body fat mass
大体时间：6 months
|
Body fat mass is expressed in percentage
|
6 months
|
|
C-reactive protein (CRP)
大体时间：6 months
|
CRP is measured in mg/L.
|
6 months
|
|
Fecal calprotectin
大体时间：6 months
|
Fecal calprotectin is measured in µg/g stool.
|
6 months
|
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International Physical Activity Questionnaire-Short Form (IPAQ-SF)
大体时间：6 months
|
International Physical Activity Questionnaire-Short Form (IPAQ-SF).
Physical activity is expressed as MET-minutes/week.
|
6 months
|
|
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
大体时间：6 months
|
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) total score is used to measure fatigue
|
6 months
|
|
Hospital Anxiety and Depression Scale (HADS)
大体时间：6 months
|
Hospital Anxiety and Depression Scale (HADS) total score
|
6 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Julajak Limsrivilai, MD, MSc、Mahidol university
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2024年11月17日
初级完成 (估计的)
2026年12月31日
研究完成 (估计的)
2026年12月31日
研究注册日期
首次提交
2025年5月6日
首先提交符合 QC 标准的
2026年8月18日
首次发布 (实际的)
2026年8月20日
研究记录更新
最后更新发布 (实际的)
2026年8月20日
上次提交的符合 QC 标准的更新
2026年8月18日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.