- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04297566
MICISPORT Survey : Questionnaire (MICISPORT)
MICISPORT Patient Questionnaire
Study Overview
Status
Conditions
Detailed Description
This questionnaire, validated with Doctor Pineton de Chambrun, is set up within the framework of an exercise thesis in pharmacy focusing on the impact of physical activity and diet on the evolution and patients' Crohn's disease (CD) experience. Along with ulcerative colitis (UC), Crohn's disease belongs to chronic inflammatory bowel disease (IBD), which is a major public health concern. These pathologies currently affect 2.5 million patients in Europe (1 million of CD versus 1.5 million of UC). More specifically, in France in 2015, there were 212,700 patients with IBD, with a proportion of 60% CD and 40% RCH1. These pathologies have a major impact on patient's lifes, both in terms of quality of life and the therapeutic course (efficacy and side effects).
Physical activity and diet are other important concerns of health authorities. They are the subject of numerous recommendations based on age and health status. The World Health Organization (WHO), for example, recommends that adults between the ages of 18 and 64 should practice endurance physical activity of moderate intensity lasting at least 150 minutes per week or 75 minutes per day, sustained intensity endurance activity, or a combination of these two types of activity. Epidemiological data show that the lack of physical activity and a sedentary lifestyle favor the increase of the prevalence of diseases, such as cancer and diabetes, but also the increase in cardiovascular risk factors, such as hypertension, obesity and hyperglycemia. A sedentary lifestyle is also considered to be the fourth risk factor for mortality worldwide. Therefore, it appears interesting to study the potential impact of physical activity and exercise as well as food consumption on the activity of Crohn's disease. This impact felt by patients will be assessed by means of a questionnaire which will be offered to them after their medical consultation. The hypothesis of this work is that physical activity and / or sports and diet control improve the quality of life for patients with Crohn's disease.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Montpellier, France, 34295
- Uhmontpellier
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria:
- Crohn's disease patients
Exclusion criteria:
- Patients without Crohn's disease
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Crohn disease's patients
Crohn's disease patients seen in gastroenterology consultation or coming in day hospital for treatment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease activity/expression
Time Frame: 1 day
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Disease activity/expression on a scale of 0 to 10 (0 corresponding to no symptoms experienced and 10 corresponding to the zenith of the symptomatology).
When analysing the questionnaire
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1 day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lived pathology
Time Frame: 1 day
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Lived pathology on a scale of 0 to 10 (0 corresponding to the worst experience and 10 to the best).
When analysing the questionnaire
|
1 day
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Guillaume BOUTA, Resident, University Hospital, Montpellier
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RECHMPL20_0027
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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