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

Inflammatory Bowel Disease Clinical Trial

— MICI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02861053
• Other study ID #: 2016/013/HP
• Status: Recruiting
• Phase: N/A
• First received: August 5, 2016
• Last updated: August 29, 2017
• Start date: September 2016
• Est. completion date: April 2018

Study information

• Verified date: August 2017
• Source: University Hospital, Rouen
• Contact: David DEBEAUMONT, MD
• Email: david.debeaumont[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Other:
• regular and moderate physical activity
regular and moderate physical activity will be done 3 times per week more than usual
• No regular and moderate physical activity more than usual
regular and moderate physical activity will be done as usual

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference from baseline in the evaluation of fatigue	Evaluation of fatigue using FACIT questionnaire	3 Month
Secondary	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
Secondary	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