Clinical trial NCT02861053: Inflammatory Bowel Disease : Could a Regular Physical Activity Reduce Patients Fatigue ?
Official title: Inflammatory Bowel Disease : Could a Regular Physical Activity Reduce Patients Fatigue ?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammatory Bowel Disease
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2016-08-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference from baseline in the evaluation of fatigue
timeFrame: 3 Month
Secondary outcomes:
measure: Difference from baseline in the Evaluation of the Quality of life
timeFrame: 3 Month
measure: Difference from baseline in the Evaluation of the Quality of life
timeFrame: 3 Month
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: David DEBEAUMONT, MD
role: PRINCIPAL_INVESTIGATOR
References: