NCT07775794 Benefit of Moderate Intensity Exercise in Patients With Clinical Quiescent Inflammatory Bowel Disease
| NCT ID | NCT07775794 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mahidol University |
| Condition | Inflammatory Bowel Disease (IBD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-11-17 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-11-17 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Julajak Limsrivilai, MD, MSc
PRINCIPAL INVESTIGATOR
Mahidol University
Frequently Asked Questions
Who can join the NCT07775794 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Inflammatory Bowel Disease (IBD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07775794 currently recruiting?
Yes, NCT07775794 is actively recruiting participants. Contact the research team at jirateeptuntikul2@gmail.com for enrollment information.
Where is the NCT07775794 trial being conducted?
This trial is being conducted at Bangkok Noi, Thailand.
Who is sponsoring the NCT07775794 clinical trial?
NCT07775794 is sponsored by Mahidol University. The principal investigator is Julajak Limsrivilai, MD, MSc at Mahidol University. The trial plans to enroll 50 participants.