Clinical trial NCT05224193: ACTIVE-IBD Study: Physical Activity and Sleep in Paediatric Inflammatory Bowel Disease
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inflammatory Bowel Diseases
Exercise
Keywords: Exercise
Sleep
Quality of Life
Physical Activity
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any disease known to interfere with exercise:

* poorly controlled asthma
* significant cardiovascular disease
* fracture
* infection

  * Unable to understand and/or cooperate with the study requirements
  * Unable to provide consent / assent to participate in the study
  * Participants will eb excluded if they are currently part of another exercise/ physical study
  * Unable to provide consent / assent to participate in study

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


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:

Primary outcomes:
measure: Moderate Vigorous Physical Activity measurement
timeFrame: Over 1 Week
measure: Sedentary time
timeFrame: 1 week
Secondary outcomes:
measure: Disease Activity
timeFrame: At Baseline Clinical Assessment
measure: Perceived Physical Activity
timeFrame: At Baseline Clinical Assessment
measure: Amount and Quality of Sleep
timeFrame: At Baseline Clinical Assessment
measure: Nutritional Assessment
timeFrame: At Baseline Clinical Assessment
measure: Growth Assessment
timeFrame: At Baseline Clinical Assessment
measure: Growth Assessment
timeFrame: At Baseline Clinical Assessment
measure: Nutrition Assessment
timeFrame: 3 day assessment after baseline visit
measure: Amount and Quality of Sleep
timeFrame: 1 week period
Other outcomes:
measure: Quality of Life Score
timeFrame: At baseline clinic assessment
Locations:
city: Southampton
country: United Kingdom
facility: Univeristy Hospital Southampton
state: Hampshire
Study officials:
References: