NCT02861053

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 10, 2016

Completed
2.1 years until next milestone

Study Start

First participant enrolled

September 11, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2020

Completed
Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

1.5 years

First QC Date

August 5, 2016

Last Update Submit

April 28, 2026

Conditions

Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

  • Difference from baseline in the evaluation of fatigue

    Evaluation of fatigue using FACIT questionnaire

    3 Month

Secondary Outcomes (2)

  • Difference from baseline in the Evaluation of the Quality of life

    3 Month

  • Difference from baseline in the Evaluation of the Quality of life

    3 Month

Study Arms (2)

chronic quiet inflammatory bowel disease patient (IBD)

EXPERIMENTAL

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

Other: regular and moderate physical activityOther: No regular and moderate physical activity more than usual

chronic quiet inflammatory bowel disease Patient (IBD)

SHAM COMPARATOR

Patient with chronic quiet inflammatory bowel disease patient (IBD) with no regular and moderate physical activity more than usual

Other: regular and moderate physical activityOther: No regular and moderate physical activity more than usual

Interventions

regular and moderate physical activityOTHER

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

chronic quiet inflammatory bowel disease Patient (IBD)chronic quiet inflammatory bowel disease patient (IBD)
No regular and moderate physical activity more than usualOTHER

regular and moderate physical activity will be done as usual

chronic quiet inflammatory bowel disease Patient (IBD)chronic quiet inflammatory bowel disease patient (IBD)

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rouen University Hospital

Rouen, France

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • David DEBEAUMONT, MD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2016

First Posted

August 10, 2016

Study Start

September 11, 2018

Primary Completion

March 4, 2020

Study Completion

March 4, 2020

Last Updated

May 4, 2026

Record last verified: 2026-04

Locations

FR(1)