CClinicalTrials.gg
Status unknownNCT05099653APMICIUpdated May 5, 2022

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

An interventional study of physical activity in Crohn Disease Haemorrhagic Rectocolitis, sponsored by Raincy Montfermeil Hospital Group. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-05.

Sponsored by Raincy Montfermeil Hospital Group · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Oct 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Feb 2020, registered Oct 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Crohn Disease Haemorrhagic Rectocolitis

Keywords

  • Physical Activity
  • Quality of Life
03

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's planned enrollment of 30 is below the median of 66 across 1,188 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Raincy Montfermeil Hospital Group is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Age \< 18 years
  • Medical contraindication to physical activity
  • Objection to participation in this study
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    patients with physical activity

    A group of patients with physical activity (protocolized)

    Other: physical activity

  • No intervention
    patients without physical activity

    A group of patients without physical activity (protocolised)

Interventions

  • Otherphysical activity

    physical activity

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 6 months

Secondary outcomes

  1. the impact of the physical activity programme on Psychological state

    To measure the impact of the physical activity programme on Psychological state (HAD score)

    Time frame: 6 months

  2. the impact of the physical activity programme on fatigue (FACIT score)

    the impact of the physical activity programme on fatigue (FACIT score)

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • 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. PubMed 27914655 ↗
  • 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. PubMed 27914657 ↗
  • 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. PubMed 23107487 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05099653
Lead sponsor
Raincy Montfermeil Hospital Group
Responsible party
Sponsor
First posted
Oct 29, 2021
Start date
Feb 20, 2020
Primary completion
Oct 31, 2022 (estimated)
Completion
Oct 31, 2022 (estimated)
Last update
May 5, 2022

Study contacts

Stéphane Nahon, MD
Contact
gastronahon@gmail.com
0141708121
Stéphane Nahon, MD
principal investigator · Raincy Montfermeil Hospital Group

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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