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

University Hospital, Rouen

Status: Completed

Conditions: Inflammatory Bowel Disease

Treatments: Other: No regular and moderate physical activity more than usual; Other: regular and moderate physical activity

Study type: Interventional

Funder types: Other

Identifiers

NCT02861053

2016/013/HP

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

chronic quiet inflammatory bowel disease patient (IBD)

Experimental group

Description:

Patient with chronic quiet inflammatory bowel disease patient (IBD) with regular and moderate physical activity

Treatment:

Other: regular and moderate physical activity

Other: No regular and moderate physical activity more than usual

chronic quiet inflammatory bowel disease Patient (IBD)

Sham Comparator group

Description:

Patient with chronic quiet inflammatory bowel disease patient (IBD) with no regular and moderate physical activity more than usual

Treatment:

Other: regular and moderate physical activity

Other: No regular and moderate physical activity more than usual