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Inflammatory Bowel DiseasesJUMP IBDNCT04067934

JUMP Inflammatory Bowel Disease Study

A study testing Jumping Exercise programme in people with Inflammatory Bowel Diseases, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Children and adolescents with inflammatory bowel disease are at increased risk of poor bone and muscle health through a variety of factors, including underlying disease processes, nutritional deficits, and reduced physical activity. Read more about this study

Who is it for?
Ages 10 to 17 years
Conditions the study is for
Inflammatory Bowel Diseases
What is being tested?
Jumping Exercise programme
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited Kingdom
Study dates
Aug 2019to Jul 2021
Phase
Interventional
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 10 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • confirmed diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis) at least 6 months prior to study involvement
  • aged 10 to 17.9 years (inclusive)
  • ability to provide written informed consent, or assent with accompanying parent/guardian consent
  • ability to mobilise and perform exercise independently
  • disease in remission, or mildly/moderately active, according to weighted Paediatric Crohn's disease activity index (wPCDAI) or Paediatric ulcerative colitis activity index (PUCAI)
  • stable medication for >4 weeks prior to study, and no planned changes of medication during study period

Who cannot join

  • lack of capacity to provide consent or assent
  • pregnancy (females)
  • recent (<12 weeks) surgery, or planned surgery during intervention period
  • significant contraindication to high-impact exercise
  • significant comorbidity
  • use of medication known to affect bone turnover (excluding that used to treat IBD [i.e. glucocorticoids])
  • BMI > +3.5 standard deviation score (SDS)
  • participating in >2 hours per week structured exercise (excluding school physical education)

Trial locations and contacts

1 site in 1 country.

Lewis Steell, BSc MSc contact

07899 883650

Lewis.Steell@glasgow.ac.uk

Jarod Sze Choong Wong, MBBS MRCPCH DMedSc contact

Jarod.Wong@glasgow.ac.uk

United Kingdom1 site
  • NHS Greater Glasgow and Clyde

    Glasgow

Other trials in United Kingdom

About this study

Official title: The Feasibility of Jumping Based Exercise to Improve Musculoskeletal Outcomes in Children and Adolescents With Inflammatory Bowel Disease (The JUMP IBD Study)

Children and adolescents with inflammatory bowel disease are at increased risk of poor bone and muscle health through a variety of factors, including underlying disease processes, nutritional deficits, and reduced physical activity.

Inflammatory bowel disease can also delay the onset of puberty in children, and pubertal development in adolescents, resulting in sub-optimal adult bone mass, therefore increasing future risk of fractures and osteoporosis. High impact exercise may be a useful additional therapy for adolescents with IBD, as the mechanical strains produced during this type of exercise, through high force muscular contractions and ground reaction forces, can promote bone formation and gains in muscle mass. There have been no previous studies assessing the effects of high impact exercise in IBD, so it is unknown if this type of exercise is feasible in this population. The aim of this study is to assess the feasibility of a short term jumping based exercise intervention for improving muscle and bone outcomes in children and adolescents with inflammatory bowel disease.

Read the detailed description

This study will incorporate a pilot/feasibility design, aiming to recruit a cohort of 15 inflammatory bowel disease patients of child and adolescent age (10 - 17.9 years). No control group will be recruited.

After potential recruits have contacted the study team to signal their interest in participation, a member of the team will contact them to discuss details of the study in more depth, and assess their suitability for participation against the inclusion/exclusion criteria. If eligible, and willing to participate, they will be asked to attend a baseline session (<28 days prior to exercise intervention) during which they will be afforded the opportunity to ask any questions they may have regarding the study.

This visit will last approximately 1.5 hours. Parent/guardian will also be encouraged to ask any questions they may have. Fully informed written consent with be obtained from the participant's parent/guardian if aged under 16 years, and written informed consent (or assent, depending on competence) will also be taken from the participant. A baseline blood sample will be collected at this session by a research nurse. Participants will complete a range of questionnaires regarding quality of life (IMPACT III, PedsQL Generic Core Scale), fatigue (PedsQL Multidimensional fatigue scale), self-efficacy for exercise. A member of the study team will measure disease activity using a clinical questionnaire (wPCDAI, PUCAI). Demographic and disease history data, and physical measurements including height, sitting height, weight, body composition (bio-electrical impedance) will also be collected. Participants will be provided a wrist-worn accelerometer to measure their habitual physical activity for the proceeding seven days, which they will be instructed to return in a provided pre-paid envelope. A kit will be given for participant to provide a stool sample, to be brought to the following study visit. The exercise intervention will consist of four weeks of three jumping based exercise sessions per week. These sessions will involve basic jumping movements, with approximately 50-100 jumps per session; incorporating 20-30 minutes of exercise. Participants will be requested to attend a one hour face-to-face session at the beginning of each intervention week so a member of the study team can teach them safe and correct execution of each of the prescribed movements for that week. Participants will be provided with an exercise log diary in which they can record adherence to each session, and detail if they have experienced any pain or falls (adverse events), or if anything has prevented them from participating in the prescribed session. Should they be unable to attend any face-to-face session, the exercise diary contains details of the prescribed exercises, and how to perform them. A member of the research team will make telephone contact with research participants and their parent/guardian once per week throughout the four weeks, on any week that they do not attend a face to face exercise session. As a minimum, participants will be expected to attend their first exercise session face-to-face with a member of the research team. Participants will be requested to wear a wrist-worn accelerometer throughout the intervention period, which will be routinely downloaded at each face-to-face session.

Follow-up visits will be completed <14 days post-intervention, at which all of the measurements from the baseline visit will be conducted again (excluding height, habitual physical activity.

Being tested
Jumping Exercise programme
Keywords
Paediatrics, Exercise
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.

  • Jumping Exercise programmeBehavioural

    Four weeks of three jumping-based exercise sessions per week. These sessions will involve basic jumping movements, with approximately 50-100 jumps per session; incorporating 20-30 minutes of exercise.

Study groups in NCT04067934
Study groupRoleWhat they receive
Jumping exerciseExperimentalHigh-impact exercise intervention: 3 sessions per week for four weeks Each session will consist of three jumping-based exercises, performed for three sets of various repetitions, following a progressive protocol with increasing volume/intensity.
Receives: Behavioral: Jumping Exercise programme

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adherence to exercise protocol

    Number of exercise repetitions/sessions completed

    Measured: 4 weeks

Secondary outcomes (8)
  1. Bone metabolism biomarker

    Blood levels of bone alkaline phosphatase

    Measured: Baseline and 4 weeks

  2. Growth hormone axis

    Blood levels of Growth Hormone (GH)/Insulin-like Growth Factor (IGF) axis

    Measured: Baseline and 4 weeks

  3. Inflammatory cytokines

    Tumour Necrosis Factor (TNF)-alpha levels

    Measured: Baseline and 4 weeks

  4. Muscle function

    Jumping mechanography power output

    Measured: Baseline and 4 weeks

  5. Disease activity

    Faecal calprotectin levels

    Measured: Baseline and 4 weeks

  6. Health-related quality of life

    Score on IMPACT III questionnaire: the scale measures disease specific quality of life in paediatric IBD patients; TOTAL Score is measured on a scale of 0 - 100; higher scores indicate better QoL; the questionnaire has Four sub-domains: Well-being, emotional functioning, social functioning and body image; all sub-domains also measured 0 - 100 scale, with higher scores indicating better QoL in that domain

    Measured: Baseline, 2 weeks and 4 weeks

  7. Fatigue

    Score on PedsQL Multidimensional fatigue scale: the scale measures generic fatigue in children and adults; Total score is measured on scale of 0 - 100; higher score indicates less fatigue; three sub-domains - general fatigue, sleep/rest fatigue, cognitive fatigue - scored on same 0 - 100 scale; higher score = less fatigue

    Measured: Baseline and 4 weeks

  8. Bio-electrical impedance as measure of Body composition

    Bio-electrical impedance

    Measured: Baseline and 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2019
  2. Study startAug 2019 (estimated)
  3. Primary completionJul 2021 (estimated)
  4. Study completionJul 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Pilot/feasibility design
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04067934
Sponsor's protocol ID
GN19GA217P
Acronym
JUMP IBD
Status last verified
Aug 2019
First submitted
25 Jul 2019
Last updated
28 Aug 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Jumping Exercise programme in people with Inflammatory Bowel Diseases, run by NHS Greater Glasgow and Clyde 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 8 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 28 Aug 2019. 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?

Contact Lewis Steell, BSc MSc (07899 883650, Lewis.Steell@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence to exercise protocol (time frame: 4 weeks). 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 28 Aug 2019.

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JUMP Inflammatory Bowel Disease Study (NCT04067934) | AzTrials