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

NCT07775794 | Recruiting DMC

• 2 other identifiers: Si 903/2024MahidolU
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inflammatory Bowel Disease (IBD)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Harvey-Bradshaw Index (HBI)

  6 months

• Mayo Ulcerative Colitis Subscore

  6 months

• Pittsburgh Sleep Quality Index (PSQI)

  6 months

• Body mass index (BMI)

  6 months

• Skeletal muscle mass

  6 months

Study Arms (2)

patients with clinical quiescent Inflammatory bowel Disease taught exercise by sport scientist

EXPERIMENTAL

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

Non exercise patient

NO INTERVENTION

Participants with clinical quiescent Inflammatory bowel Disease who do not receive exercise training or supervision from a sports scientist.

Interventions

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

patients with clinical quiescent Inflammatory bowel Disease taught exercise by sport scientist

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine Siriraj Hospital

Bangkok Noi, Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Julajak Limsrivilai, MD, MSc

  Mahidol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jirateep Tuntichamnankul, MD

CONTACT

+66 0858570247; jirateeptuntikul2@gmail.com

Julajak Limsrivilai, MD, MSc

CONTACT

+66 081-496-8895; alimsrivilai@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: August 20, 2026
• Study Start: November 17, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 20, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)