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AzTrials

Inflammatory Bowel Disease (IBD)APIMICINCT07191106

Pilot Study Assessing the Feasibility and Impact of a Remote Adapted Physical Activity Program on Quality of Life in Patients With Inflammatory Bowel Disease (IBD)

A study testing adapted physical activity in people with Inflammatory Bowel Disease (IBD) and Inflammatory Bowel Disease (Crohn&Amp;#39;s Disease and Ulcerative Colitis), run by Raincy Montfermeil Hospital Group at 2 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Inflammatory Bowel Disease (IBD) is a chronic relapsing condition that affects the gastrointestinal tract and is increasingly diagnosed in adolescents and young adults. Although anti-TNFα therapies are effective in reducing disease activity and improving quality of life, they are frequently associated with side… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
adapted physical activity
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
2 sitesFrance
Study dates
15 Sep 2025to 31 Mar 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults aged 18 years and older
  • Diagnosis of Inflammatory Bowel Disease (IBD) established for at least 6 months
  • Patient is motivated to participate in the Adapted Physical Activity (APA) program
  • Medical certificate confirming fitness to engage in remote physical activity
  • Access to a digital device with internet connectivity enabling use of the MOOV+ application at home
  • Written informed consent freely given after appropriate information
  • Affiliation with, or beneficiary of, a national health insurance system

Who cannot join

  • Patients under 18 years of age
  • Medical contraindication to physical activity
  • High levels of physical activity as defined by the International Physical Activity Questionnaire (IPAQ):
  • Total >1500 MET-min/week of vigorous activity on at least 3 days, OR
  • Total physical activity >3000 MET-min/week, regardless of distribution
  • Presence of psychological disorders that may interfere with study participation
Show all 10Show fewer
  • Lack of access to a device or internet connection enabling remote participation
  • Pregnant or breastfeeding women
  • Patients under legal guardianship or curatorship
  • Patients under legal protection

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Stephane NAHON, Professor contact

+33141708000

stephane.nahon@ght-gpne.fr

France2 sites, 2 recruiting

  • GHI Le Raincy Montfermeil

    Montfermeil, 93370

    Stephane NAHON, Professor, 0033141708000, stephane.nahon@ght-gpne.fr

    Recruiting

  • CHU Nantes

    Nantes, 44093

    Catherine LE BERRE, Doctor, 0033.2.40.08.33.33, catherine.leberre@chu-nantes.fr

    Not yet recruiting

Other trials in France

About this study

Official title: Pilot Feasibility and Impact Study of a Remote Adapted Physical Activity Program on the Quality of Life of Patients With Inflammatory Bowel Disease (IBD)

Inflammatory Bowel Disease (IBD) is a chronic relapsing condition that affects the gastrointestinal tract and is increasingly diagnosed in adolescents and young adults. Although anti-TNFα therapies are effective in reducing disease activity and improving quality of life, they are frequently associated with side effects such as fatigue, weight gain, and joint pain, which may be mitigated by regular physical activity.

Emerging evidence suggests that light to moderate physical activity may help reduce systemic and intestinal inflammation and improve IBD-related outcomes. However, access to structured physical activity programs remains limited, and personal or professional constraints may hinder participation.

Read more

This pilot study aims to assess the feasibility and impact of a remotely delivered Adapted Physical Activity (APA) program on the quality of life of patients with Inflammatory Bowel Disease (IBD), including Crohn's disease and ulcerative colitis. This study evaluates the effects of a 12-weeks remote APA intervention on quality of life as the primary outcome.

Secondary objectives include assessing changes in anxiety and depression, fatigue levels, IBD activity, and smoking behavior. The findings from this study may inform the development of scalable, non-pharmacological strategies to support symptom management and well-being in individuals with IBD.

Being tested
adapted physical activity
Keywords
IBD, crohn, ulcerative colitis
Medical subject headings
Inflammatory Bowel Diseases, Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • adapted physical activityProcedure or surgery

    Comparative before-and-after study over a 3-month period of remote Adapted Physical Activity (APA) delivered through the MOOV+ application

Study groups in NCT07191106
Study groupRoleWhat they receive
Pre- and post-intervention comparison following participation in the Adapted Physical Activity (APA)ExperimentalThere is no comparator group at this stage of the research. Patient data will be compared before and after participation in the Adapted Physical Activity (APA) program.
Receives: Procedure: adapted physical activity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Impact of a Remote Adapted Physical Activity Program Delivered via the MOOV+ Application on Quality of Life in Patients With Inflammatory Bowel Disease: A Pilot Before-and-After Study

    Change in total Inflammatory Bowel Disease Questionnaire (IBDQ-32) score between baseline and the end of the program at Month 3 (M3)

    Measured: From baseline (Month 0) to Month 3

Secondary outcomes (10)

  1. evaluate the effect of the program on the different subdomains of health-related quality of life, including bowel symptoms, systemic symptoms, emotional function, and social function

    Variation in the four IBDQ-32 subscale scores between baseline (Month 0) and the end of the program (Month 3)

    Measured: From baseline (Month 0) to Month 3

  2. Assess the feasibility of the Remote Adapted Physical Activity Program

    Variation of participation rate (number of enrolled patients / number of eligible patients)

    Measured: From baseline (Month 0) to Month 3

  3. Assess the feasibility of the of the Remote Adapted Physical Activity Program

    Adherence to the program measured by session attendance rate (sessions attended / sessions scheduled) and dropout rate (number and reasons for early withdrawal).

    Measured: From baseline (Month 0) to Month 3

  4. impact of APA on psychological status

    HADS score

    Measured: From baseline (Month 0) to Month 3

  5. impact of APA on fatigue level

    FACIT fatigue score

    Measured: From baseline (Month 0) to Month 3

  6. Impact of APA on IBD activity_ crohn's disease

    variation of Harvey-Bradshaw Index (HBI)

    Measured: From baseline (Month 0) to Month 3

  7. Impact of APA on IBD activity_ ulcerative colitis

    variation of partial mayo score

    Measured: From baseline (Month 0) to Month 3

  8. evaluation of Persistence of physical activity

    International Physical Activity Questionnaire (IPAQ )

    Measured: From baseline (Month 0) to Month 3

  9. Change in Biological Markers of Disease Activity (CRP and Fecal Calprotectin)

    The impact of Adapted Physical Activity (APA) on biological disease activity will be assessed through changes in C-reactive protein (CRP) levels and fecal calprotectin concentrations

    Measured: From baseline (Month 0) to Month 3

  10. Evaluation of satisfaction level assessed using a 5-point Likert scale.

    Evaluation of Satisfaction with a Remote Adapted Physical Activity Program Delivered via MOOV+ (from "1:Very dissatisfied" to "5 : very satisfied")

    Measured: month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2025
  2. Study start15 Sep 2025
  3. Primary completion30 Oct 2025 (estimated)
  4. Study completion31 Mar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
Pilot, multicenter, before-and-after study designed to assess the feasibility and preliminary effectiveness of a remotely delivered Adapted Physical Activity (APA) intervention via a mobile application. This is a low-risk, minimal constraint interventional study involving human participants.
Masking
None (open label)
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07191106
Sponsor's protocol ID
GHIRM_RIRCM20241122
Acronym
APIMICI
Status last verified
Sep 2025
First submitted
21 Jul 2025
Last updated
24 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Nahon S, Lahmek P, Saas C, Durance C, Olympie A, Lesgourgues B, Gendre JP. Socioeconomic and psychological factors associated with nonadherence to treatment in inflammatory bowel disease patients: results of the ISSEO survey. Inflamm Bowel Dis. 2011 Jun;17(6):1270-6. doi: 10.1002/ibd.21482. Epub 2010 Oct 25.

    PubMed 21560190

  • Sarter H, Cretin T, Savoye G, Fumery M, Leroyer A, Dauchet L, Paupard T, Coevoet H, Wils P, Richard N, Turck D, Ley D, Gower-Rousseau C; EPIMAD study Group. Incidence, prevalence and clinical presentation of inflammatory bowel diseases in Northern France: a 30-year population-based study. Lancet Reg Health Eur. 2024 Oct 18;47:101097. doi: 10.1016/j.lanepe.2024.101097. eCollection 2024 Dec.

    PubMed 39478988

  • 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

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing adapted physical activity in people with Inflammatory Bowel Disease (IBD) and Inflammatory Bowel Disease (Crohn&Amp;#39;s Disease and Ulcerative Colitis), run by Raincy Montfermeil Hospital Group at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Stephane NAHON, Professor (+33141708000, stephane.nahon@ght-gpne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Impact of a Remote Adapted Physical Activity Program Delivered via the MOOV+ Application on Quality of Life in Patients With Inflammatory Bowel Disease: A Pilot Before-and-After Study (time frame: From baseline (Month 0) to Month 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07191106, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.

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