Clinical trial NCT05099653: Study of the Impact of a Physical Activity Programme on the Quality of Life of Patients With Inflammatory Bowel Disease
Official title: Study of the Impact of a Physical Activity Programme on the Quality of Life of Patients With Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Crohn Disease Haemorrhagic Rectocolitis
Keywords: Physical Activity
Quality of Life
Lead sponsor: Raincy Montfermeil Hospital Group
Sponsor class: NETWORK
First posted: 2021-10-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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)
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: THE IMPACT OF A PHYSICAL ACTIVITY PROGRAM ON THE QUALITY OF LIFE OF PATIENTS
timeFrame: 6 months
Secondary outcomes:
measure: the impact of the physical activity programme on Psychological state
timeFrame: 6 months
measure: the impact of the physical activity programme on fatigue (FACIT score)
timeFrame: 6 months
Other outcomes:
Locations:
city: Montfermeil
country: France
facility: Stéphane Nahon
Study officials:
affiliation: Raincy Montfermeil Hospital Group
name: Stéphane Nahon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Torres J, Mehandru S, Colombel JF, Peyrin-Biroulet L. Crohn's disease. Lancet. 2017 Apr 29;389(10080):1741-1755. doi: 10.1016/S0140-6736(16)31711-1. Epub 2016 Dec 1.
citation: Ungaro R, Mehandru S, Allen PB, Peyrin-Biroulet L, Colombel JF. Ulcerative colitis. Lancet. 2017 Apr 29;389(10080):1756-1770. doi: 10.1016/S0140-6736(16)32126-2. Epub 2016 Dec 1.
citation: Gower-Rousseau C, Vasseur F, Fumery M, Savoye G, Salleron J, Dauchet L, Turck D, Cortot A, Peyrin-Biroulet L, Colombel JF. Epidemiology of inflammatory bowel diseases: new insights from a French population-based registry (EPIMAD). Dig Liver Dis. 2013 Feb;45(2):89-94. doi: 10.1016/j.dld.2012.09.005. Epub 2012 Oct 27.