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JUMP Inflammatory Bowel Disease Study (JUMP IBD)

Primary Purpose

Inflammatory Bowel Diseases

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Jumping Exercise programme
Sponsored by
NHS Greater Glasgow and Clyde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Bowel Diseases focused on measuring Paediatrics, Exercise

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • NHS Greater Glasgow and Clyde

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Jumping exercise

Arm Description

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.

Outcomes

Primary Outcome Measures

Adherence to exercise protocol
Number of exercise repetitions/sessions completed

Secondary Outcome Measures

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

Full Information

First Posted
July 25, 2019
Last Updated
August 23, 2019
Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow
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1. Study Identification

Unique Protocol Identification Number
NCT04067934
Brief Title
JUMP Inflammatory Bowel Disease Study
Acronym
JUMP IBD
Official Title
The Feasibility of Jumping Based Exercise to Improve Musculoskeletal Outcomes in Children and Adolescents With Inflammatory Bowel Disease (The JUMP IBD Study)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2019 (Anticipated)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases
Keywords
Paediatrics, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pilot/feasibility design
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Jumping exercise
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Jumping Exercise programme
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adherence to exercise protocol
Description
Number of exercise repetitions/sessions completed
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Bone metabolism biomarker
Description
Blood levels of bone alkaline phosphatase
Time Frame
Baseline and 4 weeks
Title
Growth hormone axis
Description
Blood levels of Growth Hormone (GH)/Insulin-like Growth Factor (IGF) axis
Time Frame
Baseline and 4 weeks
Title
Inflammatory cytokines
Description
Tumour Necrosis Factor (TNF)-alpha levels
Time Frame
Baseline and 4 weeks
Title
Muscle function
Description
Jumping mechanography power output
Time Frame
Baseline and 4 weeks
Title
Disease activity
Description
Faecal calprotectin levels
Time Frame
Baseline and 4 weeks
Title
Health-related quality of life
Description
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
Time Frame
Baseline, 2 weeks and 4 weeks
Title
Fatigue
Description
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
Time Frame
Baseline and 4 weeks
Title
Bio-electrical impedance as measure of Body composition
Description
Bio-electrical impedance
Time Frame
Baseline and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lewis Steell, BSc MSc
Phone
07899 883650
Email
Lewis.Steell@glasgow.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Jarod Sze Choong Wong, MBBS MRCPCH DMedSc
Email
Jarod.Wong@glasgow.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jarod Sze Choong Wong, MBBS MRCPCH DMedSc
Organizational Affiliation
University of Glasgow
Official's Role
Principal Investigator
Facility Information:
Facility Name
NHS Greater Glasgow and Clyde
City
Glasgow
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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JUMP Inflammatory Bowel Disease Study

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