Abdominally Targeted Management Exercises for Crohn's Disease Patients (TAME-CD)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorShmuel Kivity, MD
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Abdominally targeted exercises
- General exercises
Treatment groups
42 Participants
are divided into 2 treatment groupsSponsors and collaborators
Shmuel Kivity, MD
Lead sponsor
Tel-Aviv Sourasky Medical Center
Sponsor institution
Source ClinicalTrials.gov