Inflammatory Bowel Disease (IBD)IBDEXERCISENCT07775794
Benefit of Moderate Intensity Exercise in Patients With Clinical Quiescent Inflammatory Bowel Disease
A study testing Exercise in people with Inflammatory Bowel Disease (IBD), run by Mahidol University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inflammatory Bowel Disease (IBD)
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteThailand
- Study dates
- 17 Nov 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine Siriraj Hospital
Bangkok Noi, Bangkok, 10700
Jirateep Tuntichamnankul, MD, +66 0858570247, jirateeptuntikul2@gmail.com
Julajak Limsrivilai, MD, MSc, +66 081-496-8895, alimsrivilai@gmail.com
About this study
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)
- Being tested
- Exercise
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (11)
Harvey-Bradshaw Index (HBI)
Clinical relapse assessed at 6 months.
- Relapse is defined as Harvey-Bradshaw Index (HBI) >5 for Crohn's disease
Measured: 6 months
Mayo Ulcerative Colitis Subscore
Clinical relapse is defined by Mayo Ulcerative Colitis Subscore >2 for ulcerative colitis.
Measured: 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
Measured: 6 months
Body mass index (BMI)
BMI is expressed in kg/m²
Measured: 6 months
Skeletal muscle mass
Skeletal muscle mass is expressed in kg
Measured: 6 months
Body fat mass
Body fat mass is expressed in percentage
Measured: 6 months
C-reactive protein (CRP)
CRP is measured in mg/L.
Measured: 6 months
Fecal calprotectin
Fecal calprotectin is measured in µg/g stool.
Measured: 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.
Measured: 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
Measured: 6 months
Hospital Anxiety and Depression Scale (HADS)
Hospital Anxiety and Depression Scale (HADS) total score
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start17 Nov 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease (IBD)Studies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julajak Limsrivilai, MD, MSc, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07775794
- Sponsor's protocol ID
- Si 903/2024
- Other IDs
- MahidolU
- Acronym
- IBDEXERCISE
- Status last verified
- Aug 2026
- First submitted
- 6 May 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of Moderate Intensity Exercise in Patients With Clinical Quiescent Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT07775794
- Acronym / sponsor ID
- IBDEXERCISE / Si 903/2024
- Conditions
- Inflammatory Bowel Disease (IBD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 17 Nov 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with clinical quiescent Inflammatory bowel Disease taught exercise by sport scientist | Experimental | Behavioral: ExercisePatient 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 |
| Non exercise patient | No intervention | –Participants with clinical quiescent Inflammatory bowel Disease who do not receive exercise training or supervision from a sports scientist. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExercisePatient 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 | Behavioural | patients with clinical quiescent Inflammatory bowel Disease taught exercise by sport scientist |
Primary outcome
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.
11 secondary outcomes
Harvey-Bradshaw Index (HBI)
Time frame: 6 months
Mayo Ulcerative Colitis Subscore
Time frame: 6 months
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 6 months
Body mass index (BMI)
Time frame: 6 months
Skeletal muscle mass
Time frame: 6 months
Body fat mass
Time frame: 6 months
C-reactive protein (CRP)
Time frame: 6 months
Fecal calprotectin
Time frame: 6 months
International Physical Activity Questionnaire-Short Form (IPAQ-SF)
Time frame: 6 months
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Time frame: 6 months
Hospital Anxiety and Depression Scale (HADS)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julajak Limsrivilai, MD, MSc principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Inflammatory Bowel Disease (IBD), run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jirateep Tuntichamnankul, MD (+66 0858570247, jirateeptuntikul2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Inflammatory Bowel Disease Questionnaire (SIBDQ) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.