Testing special exercises for people with Crohn's disease

Trial details

Who runs it

Shmuel Kivity, MD

Trial code

NCT06917443

Record updated

8 April 2025

Original description

The goal of this clinical trial is to learn if abdominally targeted exercises can assist to manage disease activity in Crohn disease (CD) patients.Read full original descriptionShow less

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

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.

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: 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; Probiotics or antibiotics in the 15 days prior to enrollment or during the study period; Any proven current infection such as, fever, active abscess, Clostridioides difficile infection, positive stool culture, or parasite in patients with chronic diarrhea; Active peri-anal disease (fistula, abscess, fissure), stricturing or penetrating disease; 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; 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; 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).

ClinicalTrials.gov NCT06917443