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

Study Overview
=================
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

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

Conditions
-----------------
Inflammatory Bowel Diseases, Exercise

Participation Criteria
=================
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:

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Paediatric Patients with Inflammatory Bowel Disease<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Moderate Vigorous Physical Activity measurement | Amount of time spent performing moderate and vigorous physical activity | Over 1 Week | 
| Sedentary time | Amount of time spent sedentary | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Activity | Disease activity scores using either PUCAI (/85) or PCDAI (/100). Higher scores indicate more active disease | At Baseline Clinical Assessment | 
| Perceived Physical Activity | Youth Physical Activity Scale - Subjective Assessment of Moderate Vigorous Physical Activity in Hours over a 1 week retrospective period | At Baseline Clinical Assessment | 
| Amount and Quality of Sleep | Child Sleep Health Questionnaire scored out of 154 total and is parent/ carer subjective sleep assessment. Scored in four separate domains. Higher scores indicate increased duration and quality of sleep | At Baseline Clinical Assessment | 
| Nutritional Assessment | Mid Upper Arm Circumference | At Baseline Clinical Assessment | 
| Growth Assessment | Height in meters | At Baseline Clinical Assessment | 
| Growth Assessment | Weight in kg | At Baseline Clinical Assessment | 
| Nutrition Assessment | 3 day self-reported food diary | 3 day assessment after baseline visit | 
| Amount and Quality of Sleep | Accelerometer measured sleep | 1 week period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise, Sleep, Quality of Life, Physical Activity