Inflammatory Bowel DiseasesACTIVE-IBDNCT05224193
ACTIVE-IBD Study: Physical Activity and Sleep in Paediatric Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Diseases and Exercise, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Exercise
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2021to 1 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- 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:
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Univeristy Hospital Southampton
Southampton, Hampshire, SO16 6YD
Nadeem Afzal, MD, 02381208546, nadeem.afzal@uhs.nhs.uk
Christopher Roberts, MBBS, chris.roberts@uhs.nhs.uk
About this study
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
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
- Conditions
- Inflammatory Bowel Diseases, Exercise
- Keywords
- Exercise, Sleep, Quality of Life, Physical Activity
- Medical subject headings
- Inflammatory Bowel Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Paediatric Patients with Inflammatory Bowel Disease | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Moderate Vigorous Physical Activity measurement
Amount of time spent performing moderate and vigorous physical activity
Measured: Over 1 Week
Sedentary time
Amount of time spent sedentary
Measured: 1 week
Secondary outcomes (8)
Disease Activity
Disease activity scores using either PUCAI (/85) or PCDAI (/100). Higher scores indicate more active disease
Measured: 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
Measured: 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
Measured: At Baseline Clinical Assessment
Nutritional Assessment
Mid Upper Arm Circumference
Measured: At Baseline Clinical Assessment
Growth Assessment
Height in meters
Measured: At Baseline Clinical Assessment
Growth Assessment
Weight in kg
Measured: At Baseline Clinical Assessment
Nutrition Assessment
3 day self-reported food diary
Measured: 3 day assessment after baseline visit
Amount and Quality of Sleep
Accelerometer measured sleep
Measured: 1 week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start1 Nov 2021
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05224193
- Sponsor's protocol ID
- RHM CHI1102
- Other IDs
- 301029
- Acronym
- ACTIVE-IBD
- Status last verified
- Feb 2022
- First submitted
- 16 Sep 2021
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05224193
- Acronym / sponsor ID
- ACTIVE-IBD / RHM CHI1102
- Conditions
- Inflammatory Bowel Diseases, Exercise
- Keywords
- Exercise, Sleep, Quality of Life, Physical Activity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 4 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paediatric Patients with Inflammatory Bowel Disease | – | – |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Moderate Vigorous Physical Activity measurement
Time frame: Over 1 Week
Amount of time spent performing moderate and vigorous physical activity
Sedentary time
Time frame: 1 week
Amount of time spent sedentary
8 secondary outcomes
Disease Activity
Time frame: At Baseline Clinical Assessment
Perceived Physical Activity
Time frame: At Baseline Clinical Assessment
Amount and Quality of Sleep
Time frame: At Baseline Clinical Assessment
Nutritional Assessment
Time frame: At Baseline Clinical Assessment
Growth Assessment
Time frame: At Baseline Clinical Assessment
Growth Assessment
Time frame: At Baseline Clinical Assessment
Nutrition Assessment
Time frame: 3 day assessment after baseline visit
Amount and Quality of Sleep
Time frame: 1 week period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Exercise, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Moderate Vigorous Physical Activity measurement (time frame: Over 1 Week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2022.