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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMahidol University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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

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 design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: patients with clinical quiescent Inflammatory bowel Disease taught exercise by sport scientistExperimental treatment 1 intervention
Group B: Non exercise patientNo intervention 0 interventions

Trial outcomes

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.

Time frame
6 months

Secondary outcomes

1

Harvey-Bradshaw Index (HBI)

Clinical relapse assessed at 6 months. \- Relapse is defined as Harvey-Bradshaw Index (HBI) \>5 for Crohn's disease

Time frame
6 months
2

Mayo Ulcerative Colitis Subscore

Clinical relapse is defined by Mayo Ulcerative Colitis Subscore \>2 for ulcerative colitis.

Time frame
6 months
3

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

Time frame
6 months
4

Body mass index (BMI)

BMI is expressed in kg/m²

Time frame
6 months

Other outcomes

Sponsors and contacts

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