Clinical trial NCT06427135: A Multimodal Wearable Device-based Study to Evaluate the Efficacy of an Exercise Prescription Intervention in IBD
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Diseases
Keywords: Exercise interventions
Inflammatory Bowel Diseases
Wearable Device
Lead sponsor: Renmin Hospital of Wuhan University
Sponsor class: OTHER
First posted: 2024-05-23
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective randomized controlled study divided into intervention and control groups.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Therefore, this group proposes to conduct a randomized controlled trial to investigate the effects of exercise intervention on body composition and disease progression in patients with inflammatory bowel disease.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: skeletal muscle mass index
timeFrame: Weeks 0, 4, 8, 12 and 16 of treatment
Secondary outcomes:
measure: Quality of life rating
timeFrame: Weeks 0, 4, 8, 12 and 16 of treatment
measure: Psychological assessment
timeFrame: Weeks 0, 4, 8, 12 and 16 of treatment
measure: Fatigue status assessment
timeFrame: Weeks 0, 4, 8, 12 and 16 of treatment
measure: body fat percentage
timeFrame: Weeks 0, 4, 8, 12 and 16 of treatment
measure: muscle power
timeFrame: Weeks 0, 4, 8, 12 and 16 of treatment
measure: spirometry
timeFrame: Weeks 0, 4, 8, 12 and 16 of treatment
measure: Fecal calprotectin level
timeFrame: Weeks 0, 4, 8, 12 and 16 of treatment
measure: C-reaction protein level
timeFrame: Weeks 0, 4, 8, 12 and 16 of treatment
Other outcomes:
Locations:
Study officials:
affiliation: Renmin Hospital of Wuhan University
name: Ping An
role: PRINCIPAL_INVESTIGATOR
References: