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.

Study Overview

• Status: Unknown
• Conditions: Inflammatory Bowel Diseases
• Intervention / Treatment: Behavioral: Jumping Exercise programme

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.

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lewis Steell, BSc MSc; Phone Number: 07899 883650; Email: Lewis.Steell@glasgow.ac.uk
• Study Contact Backup: Name: Jarod Sze Choong Wong, MBBS MRCPCH DMedSc; Email: Jarod.Wong@glasgow.ac.uk

Study Locations

• United Kingdom
  • Glasgow, United Kingdom
    • NHS Greater Glasgow and Clyde

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Jumping Exercise programme; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to exercise protocol	Number of exercise repetitions/sessions completed	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone metabolism biomarker	Blood levels of bone alkaline phosphatase	Baseline and 4 weeks
Growth hormone axis	Blood levels of Growth Hormone (GH)/Insulin-like Growth Factor (IGF) axis	Baseline and 4 weeks
Inflammatory cytokines	Tumour Necrosis Factor (TNF)-alpha levels	Baseline and 4 weeks
Muscle function	Jumping mechanography power output	Baseline and 4 weeks
Disease activity	Faecal calprotectin levels	Baseline and 4 weeks
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
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
Bio-electrical impedance as measure of Body composition	Bio-electrical impedance	Baseline and 4 weeks

Collaborators and Investigators

• Sponsor: NHS Greater Glasgow and Clyde
• Collaborators: University of Glasgow
• Investigators: Principal Investigator: Jarod Sze Choong Wong, MBBS MRCPCH DMedSc, University of Glasgow

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2019
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: July 25, 2019
• First Submitted That Met QC Criteria: August 23, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 23, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Exercise; Paediatrics
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: GN19GA217P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No