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

NCT ID: NCT02861053

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-11
• Study Completion Date: 2020-03-04

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.

Conditions

Inflammatory Bowel Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

chronic quiet inflammatory bowel disease patient (IBD)

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

Group Type: EXPERIMENTAL

regular and moderate physical activity

Intervention Type: OTHER

regular and moderate physical activity will be done 3 times per week more than usual

No regular and moderate physical activity more than usual

Intervention Type: OTHER

regular and moderate physical activity will be done as usual

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

Group Type: SHAM_COMPARATOR

regular and moderate physical activity

Intervention Type: OTHER

regular and moderate physical activity will be done 3 times per week more than usual

No regular and moderate physical activity more than usual

Intervention Type: OTHER

regular and moderate physical activity will be done as usual

Interventions

regular and moderate physical activity

regular and moderate physical activity will be done 3 times per week more than usual

Intervention Type: OTHER

No regular and moderate physical activity more than usual

regular and moderate physical activity will be done as usual

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David DEBEAUMONT, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

Rouen University Hospital

Rouen, , France

Countries

France

Other Identifiers

2016/013/HP

Identifier Type: -

Identifier Source: org_study_id