Not yet taking people in IsraelNo phase

Testing special exercises for people with Crohn's disease

Tests abdominal-focused exercises against general exercise in adults with Crohn's disease.

Key facts

Who runs it: Shmuel Kivity, MD
Where: Tel Aviv, IsraelSee the site
Trial code: NCT06917443
Registry title: Abdominally Targeted Management Exercises for Crohn's Disease Patients (TAME-CD)
Status: Not yet recruiting
People taking part: 42 people, planned
Started: Apr 2025
Expected to end: Aug 2029
Type of study: Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested: Abdominally targeted exercises
General exercises
Record updated: 8 April 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 60 with Crohn disease that is mildly to moderately active. It tests daily abdominal exercises against general exercises over 8 weeks.

Age: 18 Years to 60 Years
Sex: All sexes
Disease stage: Crohn disease with mild to moderate activity: HBI symptom score above 4 and up to 15, plus fecal calprotectin above 150ug/gr or signs of active disease on bowel ultrasound.
Earlier treatment: No treatment, or a steady treatment that is expected to stay the same during the study (for example mesalamine for at least 6 weeks, immunomodulatory or biologics for at least 12 weeks). Stopped treatments need a set time gap before the study.
Biomarker or test result: Fecal calprotectin above 150ug/gr, or active disease on bowel ultrasound (modified Limberg score above 0 or bowel wall thickness above 3mm).

Main reasons for not taking part

Cannot do 10-15 minutes of exercise, 6 times a week
No access to or ability to use a computer or internet
Current infection, such as an active abscess or Clostridioides difficile infection
Pregnancy, planned pregnancy, or up to 3 months after giving birth
Surgery in the previous 3 months, ileostomy, pouch, or short bowel

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

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

Who cannot take part

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)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 60 years old?

Where in Israel

Department of Gastroenterology and Liver Diseases, Tel Aviv Medical CenterTel Aviv, IsraelContact: Rony Izhar, PhDNo longer taking part

About the trial

What the trial wants to find out

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

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.

The 2 groups in the trial

Abdominally targeted exercisesTreatment being tested
The interventional exercise regimen will include specific abdominally targeted exercises postulated to increase blood flow to the intestine and decrease inflammation. Patients will be asked to perform the exercises 6 days every week. Patients will be asked to complete 3 different videos repeatedly, one video per day, as many days a week as possible.
Generally recommended exercisesPlacebo, for comparison
The control arm will practice generally recommended exercises, without particular attention to the abdomen. Patients will be asked to perform the exercises 6 days every week. Patients will be asked to complete 3 different videos repeatedly, one video per day, as many days a week as possible.
Treatment: General exercises