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NCT Number: NCT07191106

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)

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.

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.

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Key information

Conditions

Inflammatory Bowel Disease (IBD) Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Disease (Crohn&Amp;#39;s Disease and Ulcerative Colitis) Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GHI Le Raincy Montfermeil, Montfermeil, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

adapted physical activity

Procedure

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

Primary outcomes

  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

    Time frame: From baseline (Month 0) to Month 3

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

Secondary outcomes

  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

    Time frame: From baseline (Month 0) to Month 3

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

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

    Time frame: From baseline (Month 0) to Month 3

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

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

    Time frame: From baseline (Month 0) to Month 3

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

  4. impact of APA on psychological status

    Time frame: From baseline (Month 0) to Month 3

    HADS score

  5. impact of APA on fatigue level

    Time frame: From baseline (Month 0) to Month 3

    FACIT fatigue score

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

    Time frame: From baseline (Month 0) to Month 3

    variation of Harvey-Bradshaw Index (HBI)

  7. Impact of APA on IBD activity_ ulcerative colitis

    Time frame: From baseline (Month 0) to Month 3

    variation of partial mayo score

  8. evaluation of Persistence of physical activity

    Time frame: From baseline (Month 0) to Month 3

    International Physical Activity Questionnaire (IPAQ )

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

    Time frame: From baseline (Month 0) to Month 3

    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

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

    Time frame: month 3

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

Study contacts

Contact information is provided by the study sponsor or research team.

Stephane NAHON, Professor

CONTACT

[email protected]

+33141708000

Sponsors and collaborators

Lead sponsor

Raincy Montfermeil Hospital Group

Network

Collaborators

  • Janssen Cilag S.A.S.

Registry information

Official study 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)

Acronym: APIMICI

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Sep 24, 2025
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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