Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06427135
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-04-25
Brief Title:
A Multimodal Wearable Device-based Study to Evaluate the Efficacy of an Exercise Prescription Intervention in IBD
Sponsor:
Ping An
Organization:
Renmin Hospital of Wuhan University
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Crohns disease CD and ulcerative colitis UCCD 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 wearers 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
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 wearers 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None