Status:
NOT_YET_RECRUITING
Abdominally Targeted Management Exercises for Crohn's Disease Patients (TAME-CD)
Lead Sponsor:
Shmuel Kivity, MD
Conditions:
Crohn Disease (CD)
IBD (Inflammatory Bowel Disease)
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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 abd...
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 mo...
Eligibility Criteria
Inclusion
- Patients with no treatment or on constant medicinal therapy, expected to remain constant: mesalamine for at least 6 weeks, steroids at least 2 weeks (≤20mg prednisone or budesonide ≤6mg), immunomodulatory at least 12 weeks or biologics/ small molecules for at least 12 weeks therapy. Patients who initiate the study on steroids will remain on a constant dose throughout the study.
- If patients stopped therapy prior to the study then they should be at least 2 weeks from stopping steroids or 5ASA, or 4 weeks from stopping small molecules, 8 weeks from stopping biologics, or 12 weeks from stopping thiopurines.
- CD patients will be included if their symptoms score \>4 and ≤15 on the HBI score
- Fecal calprotectin\>150ug/gr or evidence of an active disease per IUS defined as increased blood flow (modified Limberg score\>0) or thickness of bowel wall\>3mm
Exclusion
- Inability to commit for performing at least 10-15 minutes of exercise, 6 times a week.
- Lack of availability or capability to use a computer/ internet.
- Any proven current infection such as, fever, active abscess, Clostridioides difficile infection, positive stool culture, or parasite in patients with chronic diarrhea.
- Inability to sign informed consent and/ or complete the study protocol.
- Incompetent individuals who are unable to provide informed consent.
- Planed pregnancy or pregnancy- up to 3 months post labor.
- Subjects with chronic conditions such as active arthritis, cancer (within the previous 5 years, not including BCC, SCC), organ transplant subjects, advanced kidney or liver disease, or systemic inflammatory conditions other than IBD.
- Patients who underwent surgery in the previous 3 months, had more than 1 surgery of intestinal resection, patients with ileostomy, pouch or patients with short bowel (small intestine\<1.5 meter).
- Patients with a significant abdominal wall hernia, unless received a written confirmation from a treating surgeon.
- Active peri-anal disease (fistula, abscess, fissure), stricturing or penetrating disease
- Active extra-intestinal manifestations (not excluded are- oral aphthae and peripheral arthralgia without arthritis)
- Patients on total parenteral nutrition (TPN) or on exclusive enteral nutrition (EEN).
- Probiotics or antibiotics in the 15 days prior to enrollment or during the study period.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2029
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT06917443
Start Date
April 1 2025
End Date
August 1 2029
Last Update
April 8 2025
Active Locations (1)
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1
Department of Gastroenterology and Liver Diseases, Tel Aviv Medical Center
Tel Aviv, Israel, Israel