Benefit of Moderate Intensity Exercise in Patients With Clinical Quiescent Inflammatory Bowel Disease (IBDEXERCISE)
18 augusti 2026 uppdaterad av: Mahidol University
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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
50
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Jirateep Tuntichamnankul, MD
- Telefonnummer: +66 0858570247
- E-post: jirateeptuntikul2@gmail.com
Studera Kontakt Backup
- Namn: Julajak Limsrivilai, MD, MSc
- Telefonnummer: +66 081-496-8895
- E-post: alimsrivilai@gmail.com
Studieorter
-
-
Bangkok
-
Bangkok Noi, Bangkok, Thailand, 10700
- Rekrytering
- Faculty of Medicine Siriraj Hospital
-
Kontakt:
- Jirateep Tuntichamnankul, MD
- Telefonnummer: +66 0858570247
- E-post: jirateeptuntikul2@gmail.com
-
Kontakt:
- Julajak Limsrivilai, MD, MSc
- Telefonnummer: +66 081-496-8895
- E-post: alimsrivilai@gmail.com
-
Underutredare:
- Marianee Salaemae, BD
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: patients with clinical quiescent Inflammatory bowel Disease taught exercise by sport scientist
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
|
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
|
|
Inget ingripande: Non exercise patient
Participants with clinical quiescent Inflammatory bowel Disease who do not receive exercise training or supervision from a sports scientist.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Tidsram: 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. |
6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Harvey-Bradshaw Index (HBI)
Tidsram: 6 months
|
Clinical relapse assessed at 6 months. - Relapse is defined as Harvey-Bradshaw Index (HBI) >5 for Crohn's disease |
6 months
|
|
Mayo Ulcerative Colitis Subscore
Tidsram: 6 months
|
Clinical relapse is defined by Mayo Ulcerative Colitis Subscore >2 for ulcerative colitis.
|
6 months
|
|
Pittsburgh Sleep Quality Index (PSQI)
Tidsram: 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
|
6 months
|
|
Body mass index (BMI)
Tidsram: 6 months
|
BMI is expressed in kg/m²
|
6 months
|
|
Skeletal muscle mass
Tidsram: 6 months
|
Skeletal muscle mass is expressed in kg
|
6 months
|
|
Body fat mass
Tidsram: 6 months
|
Body fat mass is expressed in percentage
|
6 months
|
|
C-reactive protein (CRP)
Tidsram: 6 months
|
CRP is measured in mg/L.
|
6 months
|
|
Fecal calprotectin
Tidsram: 6 months
|
Fecal calprotectin is measured in µg/g stool.
|
6 months
|
|
International Physical Activity Questionnaire-Short Form (IPAQ-SF)
Tidsram: 6 months
|
International Physical Activity Questionnaire-Short Form (IPAQ-SF).
Physical activity is expressed as MET-minutes/week.
|
6 months
|
|
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Tidsram: 6 months
|
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) total score is used to measure fatigue
|
6 months
|
|
Hospital Anxiety and Depression Scale (HADS)
Tidsram: 6 months
|
Hospital Anxiety and Depression Scale (HADS) total score
|
6 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Julajak Limsrivilai, MD, MSc, Mahidol university
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
17 november 2024
Primärt slutförande (Beräknad)
31 december 2026
Avslutad studie (Beräknad)
31 december 2026
Studieregistreringsdatum
Först inskickad
6 maj 2025
Först inskickad som uppfyllde QC-kriterierna
18 augusti 2026
Första postat (Faktisk)
20 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
20 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
18 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Si 903/2024
- MahidolU (Annan identifierare: MahidolU)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
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Nej
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