JUMP Inflammatory Bowel Disease Study

NCT04067934 | Unknown

• 1 other identifier: GN19GA217P
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases

Keywords

Paediatrics; Exercise

Outcome Measures

Primary Outcomes (1)

• Adherence to exercise protocol

  Number of exercise repetitions/sessions completed

  4 weeks

Secondary Outcomes (8)

• Bone metabolism biomarker

  Baseline and 4 weeks

• Growth hormone axis

  Baseline and 4 weeks

• Inflammatory cytokines

  Baseline and 4 weeks

• Muscle function

  Baseline and 4 weeks

• Disease activity

  Baseline and 4 weeks

Study Arms (1)

Jumping exercise

EXPERIMENTAL

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

Interventions

Jumping Exercise programme BEHAVIORAL

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.

Jumping exercise

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator

Study Sites (1)

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Behavior

Study Officials

• Jarod Sze Choong Wong, MBBS MRCPCH DMedSc

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lewis Steell, BSc MSc

CONTACT

07899 883650; Lewis.Steell@glasgow.ac.uk

Jarod Sze Choong Wong, MBBS MRCPCH DMedSc

CONTACT

Jarod.Wong@glasgow.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot/feasibility design

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: August 28, 2019
• Study Start: August 1, 2019
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)