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

18. august 2026 oppdatert 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

50

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Thailand
    • Bangkok
      • Bangkok Noi, Bangkok, Thailand, 10700
        • Rekruttering
        • Faculty of Medicine Siriraj Hospital
        • Ta kontakt med:
        • Ta kontakt med:
        • Underetterforsker:
          • Marianee Salaemae, BD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Atferdsmessig: Exercise
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
Ingen inngripen: Non exercise patient
Participants with clinical quiescent Inflammatory bowel Disease who do not receive exercise training or supervision from a sports scientist.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Harvey-Bradshaw Index (HBI)
Tidsramme: 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
Tidsramme: 6 months
Clinical relapse is defined by Mayo Ulcerative Colitis Subscore >2 for ulcerative colitis.
6 months
Pittsburgh Sleep Quality Index (PSQI)
Tidsramme: 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)
Tidsramme: 6 months
BMI is expressed in kg/m²
6 months
Skeletal muscle mass
Tidsramme: 6 months
Skeletal muscle mass is expressed in kg
6 months
Body fat mass
Tidsramme: 6 months
Body fat mass is expressed in percentage
6 months
C-reactive protein (CRP)
Tidsramme: 6 months
CRP is measured in mg/L.
6 months
Fecal calprotectin
Tidsramme: 6 months
Fecal calprotectin is measured in µg/g stool.
6 months
International Physical Activity Questionnaire-Short Form (IPAQ-SF)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 6 months
Hospital Anxiety and Depression Scale (HADS) total score
6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Mahidol University

Etterforskere

  • Hovedetterforsker: Julajak Limsrivilai, MD, MSc, Mahidol university

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

17. november 2024

Primær fullføring (Antatt)

31. desember 2026

Studiet fullført (Antatt)

31. desember 2026

Datoer for studieregistrering

Først innsendt

6. mai 2025

Først innsendt som oppfylte QC-kriteriene

18. august 2026

Først lagt ut (Faktiske)

20. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Si 903/2024
  • MahidolU (Annen identifikator: MahidolU)

Plan for individuelle deltakerdata (IPD)

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NEI

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