Study of the Impact of a Physical Activity Programme on the Quality of Life of Patients With Inflammatory Bowel Disease (APMICI)
Primary Purpose
Crohn Disease Haemorrhagic Rectocolitis
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
physical activity
Sponsored by
About this trial
This is an interventional other trial for Crohn Disease Haemorrhagic Rectocolitis focused on measuring Physical Activity, Quality of Life
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
Sites / Locations
- Stéphane NahonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
patients with physical activity
patients without physical activity
Arm Description
A group of patients with physical activity (protocolized)
A group of patients without physical activity (protocolised)
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
the impact of the physical activity programme on Psychological state
To measure the impact of the physical activity programme on Psychological state (HAD score)
the impact of the physical activity programme on fatigue (FACIT score)
the impact of the physical activity programme on fatigue (FACIT score)
Full Information
NCT ID
NCT05099653
First Posted
October 18, 2021
Last Updated
April 29, 2022
Sponsor
Raincy Montfermeil Hospital Group
1. Study Identification
Unique Protocol Identification Number
NCT05099653
Brief Title
Study of the Impact of a Physical Activity Programme on the Quality of Life of Patients With Inflammatory Bowel Disease
Acronym
APMICI
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
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 20, 2020 (Actual)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
October 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Raincy Montfermeil Hospital Group
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease Haemorrhagic Rectocolitis
Keywords
Physical Activity, Quality of Life
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patients with physical activity
Arm Type
Experimental
Arm Description
A group of patients with physical activity (protocolized)
Arm Title
patients without physical activity
Arm Type
No Intervention
Arm Description
A group of patients without physical activity (protocolised)
Intervention Type
Other
Intervention Name(s)
physical activity
Intervention Description
physical activity
Primary Outcome Measure Information:
Title
THE IMPACT OF A PHYSICAL ACTIVITY PROGRAM ON THE QUALITY OF LIFE OF PATIENTS
Description
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 Outcome Measure Information:
Title
the impact of the physical activity programme on Psychological state
Description
To measure the impact of the physical activity programme on Psychological state (HAD score)
Time Frame
6 months
Title
the impact of the physical activity programme on fatigue (FACIT score)
Description
the impact of the physical activity programme on fatigue (FACIT score)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphane Nahon, MD
Phone
0141708121
Email
gastronahon@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphane Nahon, MD
Organizational Affiliation
Raincy Montfermeil Hospital Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stéphane Nahon
City
Montfermeil
ZIP/Postal Code
93370
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane R Nahon, MD
Phone
0141708121
Email
stephane.nahon@ght-gpne.fr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27914655
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.
Results Reference
result
PubMed Identifier
27914657
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.
Results Reference
result
PubMed Identifier
23107487
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.
Results Reference
result
Learn more about this trial
Study of the Impact of a Physical Activity Programme on the Quality of Life of Patients With Inflammatory Bowel Disease
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