An interventional study of Exercise interventions in Inflammatory Bowel Diseases, sponsored by Ping An. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-06-18.
Sponsored by Ping An · Not applicable, Interventional, and Treatment
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.
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.
963 studies on the registry are indexed under Intestinal Diseases; 174 are open to participants now.
This study's planned enrollment of 56 is below the median of 70 across 552 interventional studies indexed under Intestinal Diseases.
Browse Intestinal Diseases studies →Ping An is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Adding exercise intervention therapy to existing medications
Behavioral: Exercise interventions
No exercise intervention, use of existing medication.
Rehabilitation physician or rehabilitation therapist, to engage in physical exercise or patients, according to the medical examination data (including exercise test and physical strength test), according to their health, physical strength, and cardiovascular function status, with the form of a prescription for the type of exercise, intensity of exercise, exercise time and frequency of exercise, to put forward the precautions to be taken during exercise.
skeletal muscle mass index
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.
Time frame: Weeks 0, 4, 8, 12 and 16 of treatment
Quality of life rating
Changes before and after the intervention were assessed by means of a quality of life questionnaire (Inflammatory Bowel Disease Questionnaire, IBDQ) with a total score of 224, the higher the better.
Time frame: Weeks 0, 4, 8, 12 and 16 of treatment
Psychological assessment
Changes before and after the intervention were assessed by means of the Anxiety and Depression Scale (Hospital Anxiety and Depression Scale, HADS), with a total HADS score of 42, with higher scores indicating worse indicators.
Time frame: Weeks 0, 4, 8, 12 and 16 of treatment
Fatigue status assessment
Changes before and after the intervention were assessed by means of a fatigue scale (Functional Assessment of Chronic Illness Therapy, FACIT), with a total FACIT score of 52, with a higher score indicating a better indicator.
Time frame: Weeks 0, 4, 8, 12 and 16 of treatment
body fat percentage
Detecting changes in subjects' body fat percentage using a body composition analyzer
Time frame: Weeks 0, 4, 8, 12 and 16 of treatment
muscle power
Changes in muscle strength (kg) in the limbs of the subjects were detected using a plyometer.
Time frame: Weeks 0, 4, 8, 12 and 16 of treatment
spirometry
Changes in spirometry (mL) before and after the intervention were tested using an electronic spirometry tester.
Time frame: Weeks 0, 4, 8, 12 and 16 of treatment
Fecal calprotectin level
Test for changes in fecal calprotectin (FCP) levels in subjects before and after the intervention.The normal range for FCP is less than 100 ng/mL.
Time frame: Weeks 0, 4, 8, 12 and 16 of treatment
C-reaction protein level
To test for changes in subjects' C-reactive protein (CPR) levels before and after the intervention.The normal range for CRP is less than 5.2 mg/l for adult males and less than 4.6 mg/l for adult females.
Time frame: Weeks 0, 4, 8, 12 and 16 of treatment
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
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