Inflammatory Bowel Diseases Clinical Trial
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.
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 sessionÍž 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.
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