NCT05099653

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2020

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 29, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

May 5, 2022

Status Verified

October 1, 2021

Enrollment Period

2.7 years

First QC Date

October 18, 2021

Last Update Submit

April 29, 2022

Conditions

Crohn Disease Haemorrhagic Rectocolitis

Keywords

Physical ActivityQuality of Life

Outcome Measures

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)

    6 months

Secondary Outcomes (2)

  • the impact of the physical activity programme on Psychological state

    6 months

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

    6 months

Study Arms (2)

patients with physical activity

EXPERIMENTAL

A group of patients with physical activity (protocolized)

Other: physical activity

patients without physical activity

NO INTERVENTION

A group of patients without physical activity (protocolised)

Interventions

physical activityOTHER

physical activity

patients with physical activity

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient followed for IBD in the hospital of Montfermeil
  • over 18 years of age
  • medical certificate authorising the practice of physical activity
  • Informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stéphane Nahon

Montfermeil, 93370, France

RECRUITING

Related Publications (3)

  • 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.

    PMID: 27914655RESULT

  • 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.

    PMID: 27914657RESULT

  • 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.

    PMID: 23107487RESULT

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Stéphane Nahon, MD

    Raincy Montfermeil Hospital Group

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stéphane Nahon, MD

CONTACT

0141708121gastronahon@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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)
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2021

First Posted

October 29, 2021

Study Start

February 20, 2020

Primary Completion

October 31, 2022

Study Completion

October 31, 2022

Last Updated

May 5, 2022

Record last verified: 2021-10

Locations

FR(1)