Inflammatory Bowel Disease : Could a Regular Physical Activity Reduce Patients Fatigue ?

Study Overview
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Brief Summary
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The chronic fatigue is observed in approximately 40 % of the patients with a chronic quiet inflammatory bowel disease (IBD) and impacts the quality of life of the patients. The beneficial role of a regular physical activity on the quality of life of patients having an IBD was demonstrated in 5 studies including only 1 controlled one [Bilski, on 2013]. The mechanism by which the physical activity could improve the quality of life of the patients remains unknown (stress decreased, reduction of the inflammatory process) [Bilski, on 2014]. Several studies concerning other chronic pathologies such as fibromyalgia, have demonstrated the beneficial effect of a regular physical exercise to reduce the fatigue of patients. It was recently demonstrated that the chronic fatigue observed in patients with IBD came along with a physical reduction in the performances during the exercise test and a reduction in the physical activity of the patients [Vogelaar, 2015]. Our hypothesis is that a regular moderate physical activity could improve physical performance during an effort et could reduce the chronic fatigue and improve their quality of life.

Official Title
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Inflammatory Bowel Disease : Could a Regular Physical Activity Reduce Patients Fatigue ?

Conditions
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Inflammatory Bowel Disease

Intervention / Treatment
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* Other: regular and moderate physical activity
* Other: No regular and moderate physical activity more than usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥ 18 years old Patients suffering from IBD Patients with a FACIT score < 30 Patients with BD in remission with a C-reactiv protein dose < 5 Patients with Hemoglobin dosage > 10g/dl Patients with 18<BMI<30 kg/m2 Informed consent given by the patients Patients affiliated to the social security Patients living not far from the centre where the rehabilitation program will be performed Women with no risk of pregnancy (menopausal women or with contraceptive drugs). Exclusion Criteria: Patients ≥ 45 years old Inability to walk or to ride a bike Contraindication to practice physical exercise Contraindication to exercise test Participation to another research study within the week preceding the beginning of the protocol Patients unstable smokers Patients unable to keep their medical treatment stable along the study Patients with a regular intensive physical practice Patients with depression (HAD>11/21) Patients with bad sleep quality (PSQI score >5) Pregnant or breast-feeding patients Patients under legal protection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: chronic quiet inflammatory bowel disease patient (IBD)<br>Patient with chronic quiet inflammatory bowel disease patient (IBD) with regular and moderate physical activity | Other: regular and moderate physical activity<br>* regular and moderate physical activity will be done 3 times per week more than usual<br>Other: No regular and moderate physical activity more than usual<br>* regular and moderate physical activity will be done as usual<br>|
| Sham Comparator: chronic quiet inflammatory bowel disease Patient (IBD)<br>Patient with chronic quiet inflammatory bowel disease patient (IBD) with no regular and moderate physical activity more than usual | Other: regular and moderate physical activity<br>* regular and moderate physical activity will be done 3 times per week more than usual<br>Other: No regular and moderate physical activity more than usual<br>* regular and moderate physical activity will be done as usual<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference from baseline in the evaluation of fatigue | Evaluation of fatigue using FACIT questionnaire | 3 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference from baseline in the Evaluation of the Quality of life | Evaluation of the Quality of life using Quality of life scores (IBDQ) | 3 Month | 
| Difference from baseline in the Evaluation of the Quality of life | Evaluation of the Quality of life using Quality of life scores (SF36) | 3 Month |