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| ID | Type | Description | Link |
|---|---|---|---|
| MOH_2024-11-20_013744 | Other Identifier | The Israeli ministry of health |
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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:
Inflammatory bowel diseases (IBD) are chronic relapsing diseases that carry considerable impact on patients' quality of life (QoL) including objective measures such as increased bowel movements and more subjective measures such as fatigue, stress and depression. While the pathogenesis of IBD is thought to result from a deregulated immune response towards microbial antigens in a genetically predisposed person, various associations of environmental factors and disease activity have been described. These include, but are not limited to diet, stress, physical activity, and microbial composition and function.
Mild to moderate physical activity, which by itself can be beneficial for patients who suffer from chronic disabling diseases such as IBD, is thought to have positive effects on health, general well-being and stress. The positive effects of physical activity can be mediated directly and/ or secondarily through its impact on other modifying factors such as sleep quality, bowel circadian rhythm, and perceived stress. In this regard, by reducing stress through physical activity, one can not only improve patients' QoL and reported outcomes (PROMs) such as sleep quality and stress reduction, which are an important measure by themselves; but also to improve subjective measures of the disease severity. Additionally, physical activity can impact the enteric microbiome, which can be beneficial in IBD patients.
It is currently not clear whether routine physical activity, performed by IBD patients, improves their symptoms, disease activity and quality of lives and if yes, which activity is mostly recommended.
In this study, the investigator intends to further examine whether these disease-specifically designed exercise sets can improve patients' perceived QoL and positively influence clinical and biological responses.
The hypothesize anticipates performing sets of special physical exercises designed for IBD patients, compared to a control set of exercises, can result in an improved QoL, in CD patients suffering from mild to moderate disease activity.
The effect of each set of exercises on patients' QoL, clinical and biological responses through symptoms severity, inflammatory biomarkers, intestinal ultrasound, change in microbiome and gut permeability, will be evaluated.
For this aim, CD patients suffering from mild to moderate disease will be randomized to undergo either a set of specific physical exercises for CD or a control set of unrelated exercises. Patients will be randomized to either group by a computer randomization program according to disease activity (5\
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abdominally targeted exercises | Experimental | 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 exercises | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at 8 weeks |
| 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. | From enrollment to the end of treatment at 8 weeks |
| Biomarker remission rate | biomarker remission as defined by calprotectin <150 μg/g. Lower levels indicate better outcome | From enrollment to the end of treatment at 8 weeks |
| Biomarker remission rate | Biomarker remission as defined by CRP levels <5 mg/L. Lower levels indicate better outcome | From enrollment to the end of treatment at 8 weeks |
| Change from Baseline in mean values of PROMIS-29 scores | To assess the differences in patients' perceived QoL according to patients reported outcomes questionnaires: Patient-Reported Outcomes Measurement Information System (PROMIS-29) | From enrollment to the end of treatment at 8 weeks |
| Change from Baseline in mean values of IBDQ | To assess the differences in patients' perceived QoL according to patients reported outcomes questionnaires: Inflammatory Bowel Disease Questionnaire (IBDQ) | From enrollment to the end of treatment at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarker response rate | Biomarker response will be assessed by a 50% decrease in fecal calprotectin. Greater decrease indicates better response. | From enrollment to the end of treatment at 8 weeks |
| IUS remission rate |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in mean serum levels of LBP | To assess LPS binding protein (LBP) serum level as a marker of permeability | From enrollment to the end of treatment at 8 weeks |
| Change from baseline in mean serum levels of LBP |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nitsan Maharshak, Professor | Contact | +972527360384 | nitsanm@tlvmc.gov.il | |
| Rony Izhar, PhD | Contact | +972504991116 | ronyi@tlvmc.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Nitsan Maharshak, Professor | Tel Aviv Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology and Liver Diseases, Tel Aviv Medical Center | Tel Aviv | Israel | Israel |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D015212 | Inflammatory Bowel Diseases |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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Patients will be randomized to either intervention or control arm in 2:1 ratio, respectively.
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| General exercises | Other | Generally recommended exercises, without particular attention to the abdomen |
|
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.
| End of treatment at 8 weeks |
| 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. | From enrollment to 4 weeks |
| 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. | From enrollment to 4 weeks |
| Change from Baseline in mean values of PROMIS-29 scores | To assess the differences in patients' perceived QoL according to patients reported outcomes questionnaires: Patient-Reported Outcomes Measurement Information System (PROMIS-29) | From enrollment to 4 weeks |
| Change from Baseline in mean values of IBDQ | To assess the differences in patients' perceived QoL according to patients reported outcomes questionnaires: Inflammatory Bowel Disease Questionnaire (IBDQ) | From enrollment to 4 weeks |
To assess LPS binding protein (LBP) serum level as a marker of permeability
| From enrollment to 4 weeks |
| 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. | From enrollment to the end of treatment at 8 weeks |
| D001519 | Behavior |