JUMP Inflammatory Bowel Disease Study (JUMP IBD)
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Glasgow、イギリス
- NHS Greater Glasgow and Clyde
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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)
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的:Jumping exercise
High-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.
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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.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Adherence to exercise protocol
時間枠:4 weeks
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Number of exercise repetitions/sessions completed
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4 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Bone metabolism biomarker
時間枠:Baseline and 4 weeks
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Blood levels of bone alkaline phosphatase
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Baseline and 4 weeks
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Growth hormone axis
時間枠:Baseline and 4 weeks
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Blood levels of Growth Hormone (GH)/Insulin-like Growth Factor (IGF) axis
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Baseline and 4 weeks
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Inflammatory cytokines
時間枠:Baseline and 4 weeks
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Tumour Necrosis Factor (TNF)-alpha levels
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Baseline and 4 weeks
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Muscle function
時間枠:Baseline and 4 weeks
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Jumping mechanography power output
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Baseline and 4 weeks
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Disease activity
時間枠:Baseline and 4 weeks
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Faecal calprotectin levels
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Baseline and 4 weeks
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Health-related quality of life
時間枠:Baseline, 2 weeks and 4 weeks
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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
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Baseline, 2 weeks and 4 weeks
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Fatigue
時間枠:Baseline and 4 weeks
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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
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Baseline and 4 weeks
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Bio-electrical impedance as measure of Body composition
時間枠:Baseline and 4 weeks
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Bio-electrical impedance
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Baseline and 4 weeks
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協力者と研究者
捜査官
- 主任研究者:Jarod Sze Choong Wong, MBBS MRCPCH DMedSc、University of Glasgow
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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