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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05099653
Acronym
APMICI
Enrollment
30
Registered
2021-10-29
Start date
2020-02-20
Completion date
2022-10-31
Last updated
2022-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease Haemorrhagic Rectocolitis

Keywords

Physical Activity, Quality of Life

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.

Interventions

OTHERphysical activity

physical activity

Sponsors

Raincy Montfermeil Hospital Group
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

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)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
THE IMPACT OF A PHYSICAL ACTIVITY PROGRAM ON THE QUALITY OF LIFE OF PATIENTS6 monthsEVALUATE THE IMPACT OF A PHYSICAL ACTIVITY PROGRAM ON THE QUALITY OF LIFE OF PATIENTS WITH IBD (assessment by IBDQ score)

Secondary

MeasureTime frameDescription
the impact of the physical activity programme on Psychological state6 monthsTo measure the impact of the physical activity programme on Psychological state (HAD score)
the impact of the physical activity programme on fatigue (FACIT score)6 monthsthe impact of the physical activity programme on fatigue (FACIT score)

Countries

France

Contacts

Primary ContactStéphane Nahon, MD
gastronahon@gmail.com0141708121

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026