A Multimodal Wearable Device-based Study to Evaluate the Efficacy of an Exercise Prescription Intervention in Inflammatory Bowel Disease: a Single-center, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
- 主要终点
- skeletal muscle mass index
研究概览
简要总结
This project is a multimodal wearable device-based evaluation of the efficacy of an exercise prescription intervention for inflammatory bowel disease in a This is a single-center, randomized controlled clinical study to evaluate the efficacy of an exercise prescription intervention in inflammatory bowel disease based on multimodal wearable devices. The experimental group was treated with exercise intervention therapy on top of the existing medication.
详细描述
Inflammatory bowel disease (IBD) is a chronic inflammatory bowel disease that mainly involves the digestive system, including Crohn's disease (CD) and ulcerative colitis (UC).CD is characterized by abdominal pain, diarrhea, abdominal mass, fistula formation and intestinal obstruction. CD is characterized by abdominal pain, diarrhea, abdominal mass, fistula formation, and intestinal obstruction; UC is characterized by diarrhea, mucopurulent blood stools, and abdominal pain, and the peak age of onset is between 15 and 40 years old. Notably, many studies have shown that patients with inflammatory bowel disease commonly suffer from malnutrition, low body mass index (BMI), muscle atrophy, decreased bone density, and fatigue and anxiety, and that surgery is not a one-time event, with patients often requiring several surgeries.
Current treatment strategies focus on medication, nutritional support and nursing care, neglecting other possible adjunctive treatments.
Exercise interventions, as an effective adjunctive therapy for inflammatory bowel disease, have been shown to have anti-inflammatory, anti-muscle atrophic, and physical enhancement effects, improve psychological status, and also have beneficial effects on intestinal flora and intestinal absorption. Exercise is also economical, efficient and highly feasible, making it more acceptable to IBD patients. With the integration of physical medicine and the implementation of Healthy China, the role of exercise intervention in the majority of patients will be more important and its application will be more extensive.
Multimodal wearable device is a simple and efficient miniaturized smart device commonly used in the field of exercise, which can monitor the wearer's heart rate, blood oxygen, step count, exercise data in real time, etc. This group proposes to combine the multimodal wearable device as an auxiliary device with the exercise intervention for patients with inflammatory bowel disease (IBD), which is the first of its kind in China.
Most of the current studies are conducted on the conditions of small samples, single period, and single exercise modality, lack of studies on large samples and multi index evaluation, and the field has not yet formed a unified consensus on personalized exercise intervention for different levels of patients. There is still considerable work to be done on the study of exercise interventions for the treatment of inflammatory bowel disease.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Commitment to comply with the study procedures and cooperate in the implementation of the full study
- •Age ≥ 18 years old, gender is not limited
- •Muscle strength examination of all four limbs is greater than or equal to grade 3
- •Patients with a diagnosis of CD or UC in combination with clinical presentation, laboratory examination, endoscopy, imaging and histopathologic examination, with a disease course in mild to moderate activity or remission
- •Presence of low or high BMI, malnutrition, muscular dystrophy, and anxiety
- •Voluntarily sign a written informed consent
排除标准
- •Absolute contraindications to exercise: acute stages of various diseases (e.g. cerebral hemorrhage, acute stage of myocardial infarction), severe complications, severe cardiopulmonary dysfunction, severe gastrointestinal problems (e.g. gastric perforation, intestinal obstruction), severe locomotor system disorders (e.g. severe bone fracture), as well as other diseases that are not under effective control
- •Relative contraindications to exercise: severe hypertension, severe diabetes, chronic pain, cardiac arrhythmia, etc
- •Persons with unstable vital signs
- •Presence of cognitive, communication disorders
- •Patients who have recently undergone gastrointestinal surgery (<1 month) or who have not fully healed
- •Short bowel syndrome
- •Presence of extra-intestinal manifestations and complications that interfere with therapy, such as retinopathy, deep vein thrombosis, etc
- •Pregnant or lactating women
- •Active tuberculosis; if subjects are suspected of having active tuberculosis, chest X-ray, sputum and exclusion by clinical signs and symptoms are required
- •Other potential subjects who are not suitable for participation in this study
结局指标
主要结局
skeletal muscle mass index
时间窗: Weeks 0, 4, 8, 12 and 16 of treatment
Changes in skeletal muscle mass index (SMI) were detected using a body composition analyzer, and were considered statistically significant if they were higher in the intervention group than in the control group (P \< 0.05);Skeletal muscle mass index is calculated as the ratio of limb skeletal muscle mass (kg) to height (m) in kg/m\^2.
次要结局
- body fat percentage(Weeks 0, 4, 8, 12 and 16 of treatment)
- muscle power(Weeks 0, 4, 8, 12 and 16 of treatment)
- Fecal calprotectin level(Weeks 0, 4, 8, 12 and 16 of treatment)
- Quality of life rating(Weeks 0, 4, 8, 12 and 16 of treatment)
- Psychological assessment(Weeks 0, 4, 8, 12 and 16 of treatment)
- spirometry(Weeks 0, 4, 8, 12 and 16 of treatment)
- Fatigue status assessment(Weeks 0, 4, 8, 12 and 16 of treatment)
- C-reaction protein level(Weeks 0, 4, 8, 12 and 16 of treatment)
研究者
Ping An
Professor
Renmin Hospital of Wuhan University