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NCT Number: NCT07775794

Benefit of Moderate Intensity Exercise in Patients With Clinical Quiescent Inflammatory Bowel Disease

The goal of this Randomised controlled trial is to investigate the effect of exercise on changes in quality of life in in patients with clinical quiescent Inflammatory bowel Disease. The main question it aims to answer

* The Relationship Between Moderate-Intensity Exercise and Quality of Life in Patients with clinical quiescent nflammatory Bowel Disease Over a Six-Month Period * To examine the association between the recurrence of clinical symptoms(defined as a Harvey-Bradshaw Index > 5 for Crohn's disease and a Mayo Ulcerative Colitis Subscore > 2 for Ulcerative Colitis) and changes in inflammatory markers in blood and stool, comparing patients with clinical quiescent inflammatory bowel disease (IBD) who engage in regular exercise versus those who do not. * To evaluate the relationship between higher levels of physical activity and quality of life, sleep quality, and stress levels in patients with clinical quiescent IBD. * To assess changes in body composition including body mass index (BMI), fat mass, total muscle mass, skeletal muscle mass, and skeletal muscle index between patients who exercise regularly and those who do not.

Intervened participants will be encoraged in moderate-intensity exercise for at least 30 minutes per session, three times per week or more, under the supervision and guidance of a sports scientist compared participants who do not receive exercise training or supervision from a sports scientist.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients diagnosed with Crohn's disease or Ulcerative colitis.
  • Aged between 18 and 65 years.
  • Disease must be in clinical remission for at least 2 months prior to study enrollment, as defined by: Crohn's disease: Harvey-Bradshaw Index < 5 Ulcerative colitis: Mayo Ulcerative Colitis Subscore < 2
  • Not currently receiving corticosteroids,
  • If receiving immunomodulators or biologic therapy, the treatment regimen must be stable for at least 2 months prior to enrollment.
  • Participants must have access to and be capable of using online communication tools and digital platforms.

Exclusion criteria

  • Patients with medical conditions that limit the ability to exercise, including Severe joint pain or inflammatory arthritis affecting ambulation or mobility Advanced cardiac disease (New York Heart Association Class ≥ 2) Chronic lung disease or pulmonary hypertension Liver cirrhosis Chronic kidney disease stage 3 or higher

Poorly controlled non-communicable diseases, such as:

Hypertension (BP ≥ 160/100 mmHg) Diabetes mellitus with poor glycemic control (HbA1c ≥ 9% or requiring insulin therapy)

  • Patients who already engage in moderate-intensity exercise for more than 60 minutes per week on a regular basis.
  • Pregnant individuals or those planning to become pregnant during the study period.
  • Patients planning to undergo treatment changes or surgery within the next 3 months, or who have had surgery within the past 6 months.

Treatment and study plan

Exercise

Behavioral

Patient will be encouraged in moderate-intensity exercise for at least 30 minutes per session, three times per week or more, under the supervision and guidance of a sports scientist. To look for improvement of IPAQ score

Primary outcomes

  1. Short Inflammatory Bowel Disease Questionnaire (SIBDQ)

    Time frame: 6 months

    •Short Inflammatory Bowel Disease Questionnaire (SIBDQ) total score at 6 months.

    • Total score ranges from 10 to 70. Higher scores indicate better health-related quality of life.

Secondary outcomes

  1. Harvey-Bradshaw Index (HBI)

    Time frame: 6 months

    Clinical relapse assessed at 6 months.

    • Relapse is defined as Harvey-Bradshaw Index (HBI) >5 for Crohn's disease
  2. Mayo Ulcerative Colitis Subscore

    Time frame: 6 months

    Clinical relapse is defined by Mayo Ulcerative Colitis Subscore >2 for ulcerative colitis.

  3. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 6 months

    Pittsburgh Sleep Quality Index (PSQI) total score. if overall score <= 5 : good quality of sleep if Overall score >5 : poor quality of sleep

  4. Body mass index (BMI)

    Time frame: 6 months

    BMI is expressed in kg/m²

  5. Skeletal muscle mass

    Time frame: 6 months

    Skeletal muscle mass is expressed in kg

  6. Body fat mass

    Time frame: 6 months

    Body fat mass is expressed in percentage

  7. C-reactive protein (CRP)

    Time frame: 6 months

    CRP is measured in mg/L.

  8. Fecal calprotectin

    Time frame: 6 months

    Fecal calprotectin is measured in µg/g stool.

  9. International Physical Activity Questionnaire-Short Form (IPAQ-SF)

    Time frame: 6 months

    International Physical Activity Questionnaire-Short Form (IPAQ-SF). Physical activity is expressed as MET-minutes/week.

  10. Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)

    Time frame: 6 months

    Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) total score is used to measure fatigue

  11. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 6 months

    Hospital Anxiety and Depression Scale (HADS) total score

Study contacts

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

Jirateep Tuntichamnankul, MD

CONTACT

[email protected]

+66 0858570247

Julajak Limsrivilai, MD, MSc

CONTACT

[email protected]

+66 081-496-8895

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Acronym: IBDEXERCISE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

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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