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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Abdominally targeted exercises
Other interventionThe interventional exercise regimen will include specific abdominally targeted exercises postulated to increase blood flow to the intestine and decrease inflammation.
General exercises
Other interventionGenerally recommended exercises, without particular attention to the abdomen
Treatment groups
42 Participants
are divided into 2 treatment groupsGroup A: Abdominally targeted exercisesExperimental treatment 1 intervention
Group B: Generally recommended exercisesPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Clinical response rate
Clinical response rate will be assessed by using a clinical activity index, Harvey-Bradshaw index (HBI), and defined by a decrease of ≥3 points. A greater decrease is regarded as a better response.
Time frame
From enrollment to the end of treatment at 8 weeks2
Clinical remission rate
Clinical remission rate will be assessed by using a clinical activity index, HBI defined by achieving HBI\<5. Lower scores indicate lower disease activity and severity.
Time frame
From enrollment to the end of treatment at 8 weeks3
Biomarker remission rate
biomarker remission as defined by calprotectin \<150 μg/g. Lower levels indicate better outcome
Time frame
From enrollment to the end of treatment at 8 weeks4
Biomarker remission rate
Biomarker remission as defined by CRP levels \<5 mg/L. Lower levels indicate better outcome
Time frame
From enrollment to the end of treatment at 8 weeksSecondary outcomes
1
Biomarker response rate
Biomarker response will be assessed by a 50% decrease in fecal calprotectin. Greater decrease indicates better response.
Time frame
From enrollment to the end of treatment at 8 weeks2
IUS remission rate
IUS remission will be determined by modified Limberg score evaluating bowel wall vascularity. Score range between grade 0 to 4. Remission is defined by modified Limberg score= 0.
Time frame
End of treatment at 8 weeks3
Clinical remission rate
Clinical remission rate will be assessed by using a clinical activity index, HBI defined by achieving HBI\<5. Lower scores indicate lower disease activity and severity.
Time frame
From enrollment to 4 weeks4
Clinical response rate
Clinical response rate will be assessed by using a clinical activity index, Harvey-Bradshaw index (HBI), and defined by a decrease of ≥3 points. A greater decrease is regarded as a better response.
Time frame
From enrollment to 4 weeksOther outcomes
1
Change from baseline in mean serum levels of LBP
To assess LPS binding protein (LBP) serum level as a marker of permeability
Time frame
From enrollment to the end of treatment at 8 weeks2
Change from baseline in mean serum levels of LBP
To assess LPS binding protein (LBP) serum level as a marker of permeability
Time frame
From enrollment to 4 weeks3
Treatment affect on microbiome and metabolome composition or function
To evaluate the differences on microbiome and metabolome composition or function based on microbial metagenomics analysis.
Time frame
From enrollment to the end of treatment at 8 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Shmuel Kivity, MD
Lead sponsor
Tel-Aviv Sourasky Medical Center
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: