MICISPORT Survey : Questionnaire (MICISPORT)

July 28, 2020 updated by: University Hospital, Montpellier

MICISPORT Patient Questionnaire

This study offers a questionnaire to patients with Crohn's disease in order to assess their physical activity and / or sport as well as their eating habits in order to assess the impact of these lifestyle habits on activity and the symptoms of the disease.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Montpellier, France, 34295
        • Uhmontpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Any patient with Crohn's disease, seen in consultation

Description

Inclusion criteria:

- Crohn's disease patients

Exclusion criteria:

- Patients without Crohn's disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Crohn disease's patients
Crohn's disease patients seen in gastroenterology consultation or coming in day hospital for treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease activity/expression
Time Frame: 1 day
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
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lived pathology
Time Frame: 1 day
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Guillaume BOUTA, Resident, University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2020

Primary Completion (Actual)

April 1, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

March 3, 2020

First Submitted That Met QC Criteria

March 3, 2020

First Posted (Actual)

March 5, 2020

Study Record Updates

Last Update Posted (Actual)

July 29, 2020

Last Update Submitted That Met QC Criteria

July 28, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

NC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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