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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05224193

Acronym

ACTIVE-IBD

Enrollment

Registered

2022-02-04

Start date

2021-11-01

Completion date

2026-09-01

Last updated

2022-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise, Inflammatory Bowel Diseases

Keywords

Exercise, Sleep, Quality of Life, Physical Activity

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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	At Baseline Clinical Assessment	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
Growth Assessment	At Baseline Clinical Assessment	Height in meters
Nutrition Assessment	3 day assessment after baseline visit	3 day self-reported food diary
Nutritional Assessment	At Baseline Clinical Assessment	Mid Upper Arm Circumference
Disease Activity	At Baseline Clinical Assessment	Disease activity scores using either PUCAI (/85) or PCDAI (/100). Higher scores indicate more active disease

Other

Measure	Time frame	Description
Quality of Life Score	At baseline clinic assessment	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.

Countries

United Kingdom

Outcome results