ACTIVE-IBD Study: Physical Activity and Sleep in Paediatric Inflammatory Bowel Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Inflammatory Bowel Diseases, Exercise. Basic parameters: 6 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Physical ACTIVity, slEep, Fitness and Quality of Life in Children and Adolescents With Inflammatory Bowel Disease: a 5-year Prospective Observational Cohort Study - The ACTIVE-IBD Study
Overview
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
Primary outcome measures
- Moderate Vigorous Physical Activity measurement [Time frame: Over 1 Week]
- Sedentary time [Time frame: 1 week]
Secondary outcome measures (8)
- Disease Activity [Time frame: At Baseline Clinical Assessment]
- Perceived Physical Activity [Time frame: At Baseline Clinical Assessment]
- Amount and Quality of Sleep [Time frame: At Baseline Clinical Assessment]
- Nutritional Assessment [Time frame: At Baseline Clinical Assessment]
- Growth Assessment [Time frame: At Baseline Clinical Assessment]
- Growth Assessment [Time frame: At Baseline Clinical Assessment]
- Nutrition Assessment [Time frame: 3 day assessment after baseline visit]
- Amount and Quality of Sleep [Time frame: 1 week period]
Eligibility 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:
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 1 center
- Univeristy Hospital Southampton — Southampton
Identifiers
NCT: NCT05224193 · RHM CHI1102 · 301029