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

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

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02861053
Acronym
MICI
Enrollment
3
Registered
2016-08-10
Start date
2018-09-11
Completion date
2020-03-04
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Disease

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.

Interventions

OTHERregular and moderate physical activity

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

OTHERNo regular and moderate physical activity more than usual

regular and moderate physical activity will be done as usual

Sponsors

University Hospital, Rouen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Difference from baseline in the evaluation of fatigue3 MonthEvaluation of fatigue using FACIT questionnaire

Secondary

MeasureTime frameDescription
Difference from baseline in the Evaluation of the Quality of life3 MonthEvaluation of the Quality of life using Quality of life scores (IBDQ)

Countries

France

Contacts

PRINCIPAL_INVESTIGATORDavid DEBEAUMONT, MD

University Hospital, Rouen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 5, 2026