Crohn'sNot yet recruiting

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

Not applicable · Testing Abdominally targeted exercises and General exercises · 1 site · Shmuel Kivity, MD

Official record & contacts on ClinicalTrials.gov ↗

In plain English

What this trial is testing

This study is testing Abdominally targeted exercises and General exercises as a possible treatment. Condition(s) listed: Crohn Disease (CD) and IBD (Inflammatory Bowel Disease).

Participants are assigned to groups by chance (randomized).

Some participants receive a placebo or sham for comparison.

It is blinded: participants and the study team do not know who receives what.

This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).

Who can join

Ages 18 to 60
Any sex

Some of the main requirements, copied from the record:

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/…
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

Plus 1 more requirement(s). There are also 13 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

About 42 participants are expected to take part.
Start date: 2025-04 (planned).
Main results expected around 2029-04 (estimate from the record).
1 study site listed in Israel.

Main thing being measured

Clinical response rate (From enrollment to the end of treatment at 8 weeks)

In the researchers’ words

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.

This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.

Questions to ask your doctor and the trial team

Am I likely to qualify, given my health history?
What would I have to do, and how often would I need to visit?
Could I get a placebo? What happens to my current treatment?
What are the possible risks and benefits?
Are travel or other costs covered?
What happens after the trial ends?

Official details

Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional
Conditions	Crohn Disease (CD); IBD (Inflammatory Bowel Disease)
Lead sponsor	Shmuel Kivity, MD
Enrollment	42 (estimated)
Start date	2025-04
Primary completion (est.)	2029-04
First posted	2025-04-08
Last updated	2025-04-08
Official title	Abdominally Targeted Management Exercises for Crohn's Disease Patients (TAME-CD)
ClinicalTrials.gov ID	NCT06917443

Interventions

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

Full eligibility criteria (from the record)

Inclusion Criteria:

* 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 Criteria:

* 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.

Locations (1)

Site	City	Country	Site status
Department of Gastroenterology and Liver Diseases, Tel Aviv Medical Center	Tel Aviv, Israel	Israel

For contacts at each site, use the official record.

Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.