Study of the Impact of a Physical Activity Programme on the Quality of Life of Patients With Inflammatory Bowel Disease

Study Overview
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Brief Summary
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Regular physical activity at a mild to moderate intensity can control inflammation in general and intestinal inflammation in particular during IBD. The effectiveness of a physical activity programme has been evaluated during IBD, but the data are limited to a few studies. Overall, PA improves quality of life but also improves control of disease symptoms and fatigue . The aim of the present work is to evaluate the impact of a physical activity programme on quality of life in patients with IBD. This programme will also evaluate the impact of physical activity on 1) anxiety-depression, 2) fatigue (a frequent and difficult to manage symptom in IBD), 3) IBD activity, 4) smoking cessation.

Detailed Description
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Crohn's disease and haemorrhagic rectocolitis are Chronic Inflammatory Bowel Diseases (CIBD) which evolve by flare-ups interspersed with periods of remission . The incidence of these two diseases is increasing in France in adults but also and especially in children and adolescents. Indeed, according to data from the EPIMAD registry, from 1988-1990 to 2009-2011, a significant increase in the incidence of both Crohn's disease and haemorrhagic rectocolitis was observed in adolescents (10-16 years): for Crohn's disease from 4.2 to 9.5/10 5 (+126%; P <0.001) and for UC from 1.6 to 4.1/10 5 (+156%; P <0.001). Over the long term, Crohn's disease can progress to intestinal destruction that can be complicated by stricture(s), obstruction(s), fistula(s) and/or abscesses leading to surgical treatment estimated at 50% after 10 years of Crohn's disease progression 1. Anti-TNFα therapies are widely prescribed for Crohn's disease because they control symptoms, heal the mucosa, reduce hospital admissions and improve quality of life. However, they are associated with side effects often reported by patients, such as asthenia, weight gain and joint pain, symptoms that could be improved by regular physical activity. Regular physical activity at a mild to moderate intensity can control inflammation in general and intestinal inflammation in particular during IBD. The effectiveness of a physical activity programme has been evaluated during IBD, but the data are limited to a few studies. Overall, PA improves quality of life but also improves control of disease symptoms and fatigue . The aim of the present work is to evaluate the impact of a physical activity programme on quality of life in patients with IBD. This programme will also evaluate the impact of physical activity on 1) anxiety-depression, 2) fatigue (a frequent and difficult to manage symptom in IBD), 3) IBD activity, 4) smoking cessation.

Official Title
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Study of the Impact of a Physical Activity Programme on the Quality of Life of Patients With Inflammatory Bowel Disease

Conditions
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Crohn Disease Haemorrhagic Rectocolitis

Intervention / Treatment
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* Other: physical activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient followed for IBD in the hospital of Montfermeil over 18 years of age medical certificate authorising the practice of physical activity Informed consent Exclusion Criteria: Age < 18 years Medical contraindication to physical activity Objection to participation in this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Comparisons of two parallel groups of patients. The constitution of the two groups will be done by randomisation. A group of 10 to 12 patients with physical activity (protocolised) A group of 10 to 12 patients without physical activity (protocolised)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients with physical activity<br>A group of patients with physical activity (protocolized) | Other: physical activity<br>* physical activity<br>|
| No Intervention: patients without physical activity<br>A group of patients without physical activity (protocolised) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| THE IMPACT OF A PHYSICAL ACTIVITY PROGRAM ON THE QUALITY OF LIFE OF PATIENTS | EVALUATE THE IMPACT OF A PHYSICAL ACTIVITY PROGRAM ON THE QUALITY OF LIFE OF PATIENTS WITH IBD (assessment by IBDQ score) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the impact of the physical activity programme on Psychological state | To measure the impact of the physical activity programme on Psychological state (HAD score) | 6 months | 
| the impact of the physical activity programme on fatigue (FACIT score) | the impact of the physical activity programme on fatigue (FACIT score) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical Activity, Quality of Life