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

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.

Study Overview

• Status: Terminated
• Conditions: Inflammatory Bowel Disease
• Intervention / Treatment: Other: regular and moderate physical activity; Other: No regular and moderate physical activity more than usual

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rouen, France
    • Rouen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: David DEBEAUMONT, MD, University Hospital, Rouen

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2018
• Primary Completion (Actual): March 4, 2020
• Study Completion (Actual): March 4, 2020

Study Registration Dates

• First Submitted: August 5, 2016
• First Submitted That Met QC Criteria: August 5, 2016
• First Posted (Estimated): August 10, 2016

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases
• Other Study ID Numbers: 2016/013/HP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No