Inflammatory Bowel Disease : Could a Regular Physical Activity Reduce Patients Fatigue ? (MICI)
Primary Purpose
Inflammatory Bowel Disease
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
regular and moderate physical activity
No regular and moderate physical activity more than usual
Sponsored by
About this trial
This is an interventional supportive care trial for Inflammatory Bowel Disease
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
Sites / Locations
- Rouen University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
chronic quiet inflammatory bowel disease patient (IBD)
chronic quiet inflammatory bowel disease Patient (IBD)
Arm Description
Patient with chronic quiet inflammatory bowel disease patient (IBD) with regular and moderate physical activity
Patient with chronic quiet inflammatory bowel disease patient (IBD) with no regular and moderate physical activity more than usual
Outcomes
Primary Outcome Measures
Difference from baseline in the evaluation of fatigue
Evaluation of fatigue using FACIT questionnaire
Secondary Outcome Measures
Difference from baseline in the Evaluation of the Quality of life
Evaluation of the Quality of life using Quality of life scores (IBDQ)
Difference from baseline in the Evaluation of the Quality of life
Evaluation of the Quality of life using Quality of life scores (SF36)
Full Information
NCT ID
NCT02861053
First Posted
August 5, 2016
Last Updated
August 29, 2017
Sponsor
University Hospital, Rouen
1. Study Identification
Unique Protocol Identification Number
NCT02861053
Brief Title
Inflammatory Bowel Disease : Could a Regular Physical Activity Reduce Patients Fatigue ?
Acronym
MICI
Official Title
Inflammatory Bowel Disease : Could a Regular Physical Activity Reduce Patients Fatigue ?
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
April 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
chronic quiet inflammatory bowel disease patient (IBD)
Arm Type
Experimental
Arm Description
Patient with chronic quiet inflammatory bowel disease patient (IBD) with regular and moderate physical activity
Arm Title
chronic quiet inflammatory bowel disease Patient (IBD)
Arm Type
Sham Comparator
Arm Description
Patient with chronic quiet inflammatory bowel disease patient (IBD) with no regular and moderate physical activity more than usual
Intervention Type
Other
Intervention Name(s)
regular and moderate physical activity
Intervention Description
regular and moderate physical activity will be done 3 times per week more than usual
Intervention Type
Other
Intervention Name(s)
No regular and moderate physical activity more than usual
Intervention Description
regular and moderate physical activity will be done as usual
Primary Outcome Measure Information:
Title
Difference from baseline in the evaluation of fatigue
Description
Evaluation of fatigue using FACIT questionnaire
Time Frame
3 Month
Secondary Outcome Measure Information:
Title
Difference from baseline in the Evaluation of the Quality of life
Description
Evaluation of the Quality of life using Quality of life scores (IBDQ)
Time Frame
3 Month
Title
Difference from baseline in the Evaluation of the Quality of life
Description
Evaluation of the Quality of life using Quality of life scores (SF36)
Time Frame
3 Month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David DEBEAUMONT, MD
Email
david.debeaumont@chu-rouen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Julien BLOT
Email
julien.blot@chu-rouen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David DEBEAUMONT, MD
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rouen University Hospital
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David DEBEAUMONT, MD
First Name & Middle Initial & Last Name & Degree
David DEBEAUMONT, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Inflammatory Bowel Disease : Could a Regular Physical Activity Reduce Patients Fatigue ?
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