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

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Disease (IBD)
• Intervention / Treatment: Behavioral: Exercise

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jirateep Tuntichamnankul, MD; Phone Number: +66 0858570247; Email: jirateeptuntikul2@gmail.com
• Study Contact Backup: Name: Julajak Limsrivilai, MD, MSc; Phone Number: +66 081-496-8895; Email: alimsrivilai@gmail.com

Study Locations

• Thailand
  • Bangkok
    • Bangkok Noi, Bangkok, Thailand, 10700
      • Recruiting
      • Faculty of Medicine Siriraj Hospital
      • Contact: Jirateep Tuntichamnankul, MD; Phone Number: +66 0858570247; Email: jirateeptuntikul2@gmail.com
      • Contact: Julajak Limsrivilai, MD, MSc; Phone Number: +66 081-496-8895; Email: alimsrivilai@gmail.com
      • Sub-Investigator: Marianee Salaemae, BD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients with clinical quiescent Inflammatory bowel Disease taught exercise by sport scientist; 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	Behavioral: Exercise; 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
No Intervention: Non exercise patient; Participants with clinical quiescent Inflammatory bowel Disease who do not receive exercise training or supervision from a sports scientist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Inflammatory Bowel Disease Questionnaire (SIBDQ)	•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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Harvey-Bradshaw Index (HBI)	Clinical relapse assessed at 6 months. - Relapse is defined as Harvey-Bradshaw Index (HBI) >5 for Crohn's disease	6 months
Mayo Ulcerative Colitis Subscore	Clinical relapse is defined by Mayo Ulcerative Colitis Subscore >2 for ulcerative colitis.	6 months
Pittsburgh Sleep Quality Index (PSQI)	Pittsburgh Sleep Quality Index (PSQI) total score. if overall score <= 5 : good quality of sleep if Overall score >5 : poor quality of sleep	6 months
Body mass index (BMI)	BMI is expressed in kg/m²	6 months
Skeletal muscle mass	Skeletal muscle mass is expressed in kg	6 months
Body fat mass	Body fat mass is expressed in percentage	6 months
C-reactive protein (CRP)	CRP is measured in mg/L.	6 months
Fecal calprotectin	Fecal calprotectin is measured in µg/g stool.	6 months
International Physical Activity Questionnaire-Short Form (IPAQ-SF)	International Physical Activity Questionnaire-Short Form (IPAQ-SF). Physical activity is expressed as MET-minutes/week.	6 months
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)	Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) total score is used to measure fatigue	6 months
Hospital Anxiety and Depression Scale (HADS)	Hospital Anxiety and Depression Scale (HADS) total score	6 months

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Julajak Limsrivilai, MD, MSc, Mahidol University

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 6, 2025
• First Submitted That Met QC Criteria: August 18, 2026
• First Posted (Actual): August 20, 2026

Study Record Updates

• Last Update Posted (Actual): August 20, 2026
• Last Update Submitted That Met QC Criteria: August 18, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: Si 903/2024; MahidolU (Other Identifier: MahidolU)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No