A Multimodal Wearable Device-based Study to Evaluate the Efficacy of an Exercise Prescription Intervention in IBD

Launched by PING AN · May 18, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating how effective an exercise program can be for people with Inflammatory Bowel Diseases (IBD), such as Crohn’s disease and ulcerative colitis. The study will use a wearable device to monitor participants while they follow an exercise prescription, in addition to their regular medications. The goal is to see if this combination can help improve their health.

To be eligible for the study, participants must be at least 18 years old and have a diagnosis of IBD that is currently mild to moderate or in remission. They should also be able to perform basic movements with their limbs. However, people with certain serious health conditions, recent surgeries, or other complications may not qualify to ensure safety during the exercise program. Participants will be expected to commit to the study procedures and complete all necessary assessments. This trial aims to explore how exercise can support the treatment of IBD, potentially leading to better health outcomes for those living with these conditions.

Gender

ALL

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