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

Not Applicable

• Conditions: Inflammatory Bowel Disease

• Registration Number: NCT02861053
• Lead Sponsor: University Hospital, Rouen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-05
• Study First Submitted QC: 2016-08-05
• Study First Posted: 2016-08-10
• Study Start: 2016-09
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-29
• Last Update Posted: 2017-08-30
• Primary Completion: 2018-04
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Difference from baseline in the evaluation of fatigue	3 Month	Evaluation of fatigue using FACIT questionnaire

Secondary Outcome Measures

Name	Time	Method
Difference from baseline in the Evaluation of the Quality of life	3 Month	Evaluation of the Quality of life using Quality of life scores (SF36)

Trial Locations

Locations (1)

Rouen University Hospital; 🇫🇷 Rouen, France