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ACTIVE-IBD Study: Physical Activity and Sleep in Paediatric Inflammatory Bowel Disease

Sponsor: University Hospital Southampton NHS Foundation Trust

NCT ID: NCT05224193

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Not specified by the sponsor
How long the study runs
Study runs about 58 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
6 Years to 18 Years
Who
All
Number of participants
50
Started
2021-11-01
Last checked
2022-02

Plain English Summary

What is this study?

  • • Testing a new treatment for inflammatory bowel diseases
  • • Clinical study - 50 participants
  • • Assessment of physical activity on children with Inflammatory Bowel Disease using questionnaires and wrist watch based activity monitors

Who can take part?

  • • Ages 6 Years to 18 Years
  • • Diagnosed with inflammatory bowel diseases

Where?

  • • Southampton - Univeristy Hospital Southampton

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

Assessment of physical activity on children with Inflammatory Bowel Disease using questionnaires and wrist watch based activity monitors. The participants will be recruited from paediatric IBD clinics and will undergo questionnaires to assess their activity level, disease activity and quality of life scores. The participants will then be invited to wear a wrist based accelerometer for a week. The participants will complete a physical activity diary, food diary and stool chart at the same time. Results will be analysed to see the level of physical activity and assess if the participants are meeting the recommended level of physical activity

Inflammatory Bowel DiseasesExercise

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 6 Years - 18 Years
  • Who can join: All genders

What the study is looking for

  • ✓Children/adolescents from age of 6 to 18 years of age
  • ✓Confirmed endoscopic/histology based IBD diagnosis
  • ✓Under the care of the Southampton University Hospitals NHS Foundation Trust paediatric gastroenterology team
  • ✓Able to provide consent / assent to participate in the study
  • ✓Able to understand and/or cooperate with the study requirements
See the full criteria
Inclusion Criteria: * Children/adolescents from age of 6 to 18 years of age * Confirmed endoscopic/histology based IBD diagnosis * Under the care of the Southampton University Hospitals NHS Foundation Trust paediatric gastroenterology team * Able to provide consent / assent to participate in the study * Able to understand and/or cooperate with the study requirements * Pregnant participants will be included as long as they can complete the physical assessmentsExclusion Criteria:

Where Is This Study? (1 UK site)

Univeristy Hospital Southampton

Southampton SO16 6YD, United Kingdom

Recruiting
Site contact (verified)
Christopher Roberts, MBBSchris.roberts@uhs.nhs.uk
Data sourced from ClinicalTrials.gov · Last verified: 2022-02