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

Recruiting

• Conditions: Inflammatory Bowel Diseases; Exercise

• Registration Number: NCT05224193
• Lead Sponsor: University Hospital Southampton NHS Foundation Trust

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-16
• Study Start: 2021-11-01
• Study First Submitted QC: 2022-01-24
• Status Verified: 2022-02
• Study First Posted: 2022-02-04
• Last Update Submitted: 2022-02-22
• Last Update Posted: 2022-03-10
• Primary Completion: 2022-04-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 assessments

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sedentary time	1 week	Amount of time spent sedentary
Moderate Vigorous Physical Activity measurement	Over 1 Week	Amount of time spent performing moderate and vigorous physical activity

Secondary Outcome Measures

Name	Time	Method
Perceived Physical Activity	At Baseline Clinical Assessment	Youth Physical Activity Scale - Subjective Assessment of Moderate Vigorous Physical Activity in Hours over a 1 week retrospective period
Amount and Quality of Sleep	1 week period	Accelerometer measured sleep
Disease Activity	At Baseline Clinical Assessment	Disease activity scores using either PUCAI (/85) or PCDAI (/100). Higher scores indicate more active disease
Nutrition Assessment	3 day assessment after baseline visit	3 day self-reported food diary
Growth Assessment	At Baseline Clinical Assessment	Weight in kg
Nutritional Assessment	At Baseline Clinical Assessment	Mid Upper Arm Circumference

Trial Locations

Locations (1)

Univeristy Hospital Southampton; 🇬🇧 Southampton, Hampshire, United Kingdom