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

Condition(s) studied

Investigational drug(s) / intervention(s)

Abdominally targeted exercises: The interventional exercise regimen will include specific abdominally targeted exercises postulated to increase blood flow to the intestine and decrease inflammation.

General exercises: Generally recommended exercises, without particular attention to the abdomen

Study summary

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

Primary outcome measure(s)

• Clinical response rate — From enrollment to the end of treatment at 8 weeks
  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.
• Clinical remission rate — From enrollment to the end of treatment at 8 weeks
  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.
• Biomarker remission rate — From enrollment to the end of treatment at 8 weeks
  biomarker remission as defined by calprotectin \<150 μg/g. Lower levels indicate better outcome
• Biomarker remission rate — From enrollment to the end of treatment at 8 weeks
  Biomarker remission as defined by CRP levels \<5 mg/L. Lower levels indicate better outcome
• Change from Baseline in mean values of PROMIS-29 scores — From enrollment to the end of treatment at 8 weeks
  To assess the differences in patients' perceived QoL according to patients reported outcomes questionnaires: Patient-Reported Outcomes Measurement Information System (PROMIS-29)
• Change from Baseline in mean values of IBDQ — From enrollment to the end of treatment at 8 weeks
  To assess the differences in patients' perceived QoL according to patients reported outcomes questionnaires: Inflammatory Bowel Disease Questionnaire (IBDQ)

Trial sites (1)

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