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

Inflammatory Bowel Diseases Clinical Trial

— ACTIVE-IBD  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05224193
• Other study ID #: RHM CHI1102
• Secondary ID: 301029
• Status: Recruiting
• Start date: November 1, 2021
• Est. completion date: September 1, 2026

Study information

• Verified date: February 2022
• Source: University Hospital Southampton NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 1, 2026
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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:

Related Conditions & MeSH terms

• Exercise
• Inflammatory Bowel Diseases
• Intestinal Diseases

Locations

Country	Name	City	State
United Kingdom	Univeristy Hospital Southampton	Southampton	Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Southampton NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of Life Score	Paediatric Quality of Life Score - PEDSQL scored in psychosocial and physical sections. Both are scored out of 100 and the higher the score the better health related quality of life.	At baseline clinic assessment
Primary	Moderate Vigorous Physical Activity measurement	Amount of time spent performing moderate and vigorous physical activity	Over 1 Week
Primary	Sedentary time	Amount of time spent sedentary	1 week
Secondary	Disease Activity	Disease activity scores using either PUCAI (/85) or PCDAI (/100). Higher scores indicate more active disease	At Baseline Clinical Assessment
Secondary	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
Secondary	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
Secondary	Nutritional Assessment	Mid Upper Arm Circumference	At Baseline Clinical Assessment
Secondary	Growth Assessment	Height in meters	At Baseline Clinical Assessment
Secondary	Growth Assessment	Weight in kg	At Baseline Clinical Assessment
Secondary	Nutrition Assessment	3 day self-reported food diary	3 day assessment after baseline visit
Secondary	Amount and Quality of Sleep	Accelerometer measured sleep	1 week period