Inflammatory Bowel Disease (IBD)
Conditions
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.
Interventions
BEHAVIORALExercise
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
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short Inflammatory Bowel Disease Questionnaire (SIBDQ) | 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
| Measure | Time frame | Description |
|---|---|---|
| Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | 6 months | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) total score is used to measure fatigue |
| Hospital Anxiety and Depression Scale (HADS) | 6 months | Hospital Anxiety and Depression Scale (HADS) total score |
| Pittsburgh Sleep Quality Index (PSQI) | 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 |
| Body mass index (BMI) | 6 months | BMI is expressed in kg/m² |
| Skeletal muscle mass | 6 months | Skeletal muscle mass is expressed in kg |
| Body fat mass | 6 months | Body fat mass is expressed in percentage |
| C-reactive protein (CRP) | 6 months | CRP is measured in mg/L. |
| Fecal calprotectin | 6 months | Fecal calprotectin is measured in µg/g stool. |
| Harvey-Bradshaw Index (HBI) | 6 months | Clinical relapse assessed at 6 months. \- Relapse is defined as Harvey-Bradshaw Index (HBI) \>5 for Crohn's disease |
| International Physical Activity Questionnaire-Short Form (IPAQ-SF) | 6 months | International Physical Activity Questionnaire-Short Form (IPAQ-SF). Physical activity is expressed as MET-minutes/week. |
| Mayo Ulcerative Colitis Subscore | 6 months | Clinical relapse is defined by Mayo Ulcerative Colitis Subscore \>2 for ulcerative colitis. |
Countries
Thailand
Contacts
CONTACTJirateep Tuntichamnankul, MD
CONTACTJulajak Limsrivilai, MD, MSc
PRINCIPAL_INVESTIGATORJulajak Limsrivilai, MD, MSc
Mahidol University
Outcome results
None listed