Inflammatory Bowel Diseases Clinical Trial
— JUMP IBDOfficial 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.
Status | Not yet recruiting |
Enrollment | 15 |
Est. completion date | July 2021 |
Est. primary completion date | July 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 17 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | NHS Greater Glasgow and Clyde | Glasgow |
Lead Sponsor | Collaborator |
---|---|
NHS Greater Glasgow and Clyde | University of Glasgow |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adherence to exercise protocol | Number of exercise repetitions/sessions completed | 4 weeks | |
Secondary | Bone metabolism biomarker | Blood levels of bone alkaline phosphatase | Baseline and 4 weeks | |
Secondary | Growth hormone axis | Blood levels of Growth Hormone (GH)/Insulin-like Growth Factor (IGF) axis | Baseline and 4 weeks | |
Secondary | Inflammatory cytokines | Tumour Necrosis Factor (TNF)-alpha levels | Baseline and 4 weeks | |
Secondary | Muscle function | Jumping mechanography power output | Baseline and 4 weeks | |
Secondary | Disease activity | Faecal calprotectin levels | Baseline and 4 weeks | |
Secondary | 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 | Baseline, 2 weeks and 4 weeks | |
Secondary | 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 | Baseline and 4 weeks | |
Secondary | Bio-electrical impedance as measure of Body composition | Bio-electrical impedance | Baseline and 4 weeks |
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