NCT06917443

Abdominally Targeted Management Exercises for Crohn's Disease Patients (TAME-CD)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Shmuel Kivity, MD · Other Government
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if abdominally targeted exercises can assist to manage disease activity in Crohn disease (CD) patients. The main questions it aims to answer are: Does abdominally targeted exercises can improve the quality of life of CD patients. Does abdominally targeted exercises positively influence clinical and biological responses in CD patients. Researchers will compare performing sets of special physical exercises designed for CD patients, compared to a control set of exercises ("generic" physical activity) to see if exercises designed for CD can result in an improved quality of life, in CD patients suffering from mild to moderate disease activity. Participants will: * Perform physical exercises designed for CD or control set of exercises every day for 8 weeks. * Visit the clinic once every 4 weeks for doctor visit, blood and stool test and filling out questionnaires.

Detailed description

Inflammatory bowel diseases (IBD) are chronic relapsing diseases that carry considerable impact on patients' quality of life (QoL) including objective measures such as increased bowel movements and more subjective measures such as fatigue, stress and depression. While the pathogenesis of IBD is thought to result from a deregulated immune response towards microbial antigens in a genetically predisposed person, various associations of environmental factors and disease activity have been described. These include, but are not limited to diet, stress, physical activity, and microbial composition and function. Mild to moderate physical activity, which by itself can be beneficial for patients who suffer from chronic disabling diseases such as IBD, is thought to have positive effects on health, general well-being and stress. The positive effects of physical activity can be mediated directly and/ or secondarily through its impact on other modifying factors such as sleep quality, bowel circadian rhythm, and perceived stress. In this regard, by reducing stress through physical activity, one can not only improve patients' QoL and reported outcomes (PROMs) such as sleep quality and stress reduction, which are an important measure by themselves; but also to improve subjective measures of the disease severity. Additionally, physical activity can impact the enteric microbiome, which can be beneficial in IBD patients. It is currently not clear whether routine physical activity, performed by IBD patients, improves their symptoms, disease activity and quality of lives and if yes, which activity is mostly recommended. In this study, the investigator intends to further examine whether these disease-specifically designed exercise sets can improve patients' perceived QoL and positively influence clinical and biological responses. The hypothesize anticipates performing sets of special physical exercises designed for IBD patients, compared to a control set of exercises, can result in an improved QoL, in CD patients suffering from mild to moderate disease activity. The effect of each set of exercises on patients' QoL, clinical and biological responses through symptoms severity, inflammatory biomarkers, intestinal ultrasound, change in microbiome and gut permeability, will be evaluated. For this aim, CD patients suffering from mild to moderate disease will be randomized to undergo either a set of specific physical exercises for CD or a control set of unrelated exercises. Patients will be randomized to either group by a computer randomization program according to disease activity (5\<HBI≤7 or 7\<HBI≤15) and biomarker status (Fecal calprotectin below or above 350ugr/gr). Patients will receive an email with the link to an internet site where they will be able to watch the exercise program. Videos sets of exercises will be available online and patients will be able to watch and follow these videos at their home. Each video will include explicit instructions and examples for each of the exercises. Compliance will be documented by the study coordinator (by mail or phone call) every week during the first 2 weeks and then every 2 weeks until the end of the study. This will be verified through the software itself, which documents whenever a patient activates the video. All patients should remain on consistent dietary regimen throughout the study period. Patients will attend research visits at weeks 0, 4, and 8. During visits patients will answer questionnaires for QoL (IBDQ), and PROMs (PROMIS-29); and will be monitored for disease activity. At these time points, patients will give biologic samples: 1. Serum- 20 ml of blood will be drawn for serum analysis of CRP concentration and for LPS binding protein (LBP). Serum will also be frozen for future metabolome analysis. 2. Stool - analyzed for inflammatory marker calprotectin, as well as microbial composition and function. Data collection will include basic medical and demographic information, including gender, age, weight, height, smoking and exercise habits. Medical data will include age at diagnosis, disease duration, CD Montreal classification, HBI (Harvey-Bradshaw Index), lab results (CRP, LBP and calprotectin), comorbidities, medications history and previous intestinal surgery.

Conditions

• Crohn Disease (CD)
• IBD (Inflammatory Bowel Disease)

Interventions

Type	Name	Description
OTHER	Abdominally targeted exercises	The interventional exercise regimen will include specific abdominally targeted exercises postulated to increase blood flow to the intestine and decrease inflammation.
OTHER	General exercises	Generally recommended exercises, without particular attention to the abdomen

Timeline

• Start date: 2025-04-01
• Primary completion: 2029-04-01
• Completion: 2029-08-01
• First posted: 2025-04-08
• Last updated: 2025-04-08

Locations

1 site across 1 country: Israel