Exercise Training in Youth With Inflammatory Bowel Disease

Not Applicable

Completed

• Conditions: Pediatric Inflammatory Bowel Diseases; Pediatric Ulcerative Colitis; Pediatric Crohns Disease
• Interventions: Other: Exercise training program

• Registration Number: NCT05591976
• Lead Sponsor: McMaster University

Brief Summary

Children and adolescents with inflammatory bowel disease (IBD) suffer from many extra-intestinal side effects, including impaired muscle strength, low aerobic fitness, low bone density, and chronic inflammation. While exercise training can help remedy these issues in adults with IBD, no studies have examined the physiological effects of a structured aerobic and resistance exercise training intervention for youth with IBD.

The aim of this pilot study is to to assess the feasibility, safety, and participant satisfaction of a structured 16-week training program for children with IBD. The secondary objectives of this study were to quantify the effects of a 16-week exercise training program on select physiological and behavioural outcomes in children with IBD.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-01
• Primary Completion: 2014-06-01
• Study Completion: 2014-06-01
• Study First Submitted: 2022-09-20
• Status Verified: 2022-10
• Study First Submitted QC: 2022-10-20
• Last Update Submitted: 2022-10-20
• Study First Posted: 2022-10-24
• Last Update Posted: 2022-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• In remission (score of >10) according to the pediatric Crohn's disease activity index (PCDAI) or the ulcerative colitis activity index (PUCAI)
• Confirmed IBD diagnosis

Exclusion Criteria

• Children who exercise train 3 times a week of more

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exercise group	Exercise training program	Participants are assessed for outcomes prior to intervention, mid-way through intervention and immediately after intervention.

Primary Outcome Measures

Name	Time	Method
Changes in IBD-related symptoms: Pediatric Crohn's Disease Activity Index	Change from baseline at 8 weeks and 1 week post intervention	Tracking changes in IBD-related symptoms based on Pediatric Crohn's Disease Activity Index (scored 0-100, where higher score indicates more severe disease)
Recruitment	Change from baseline at 8 weeks and 1 week post intervention	Measure of patient recruitment (number of patients approached, enrolled, refused)
Retention	Change from baseline at 8 weeks and 1 week post intervention	Percent of patients that completed the study after enrolment
Changes in IBD-related symptoms: Pediatric Ulcerative Colitis Activity Index	Change from baseline at 8 weeks and 1 week post intervention	Tracking changes in IBD-related symptoms based on Pediatric Ulcerative Colitis Activity Index (scored 0-85, where higher score indicates more severe disease)
Qualitative assessment of participant likes and dislikes of the training program and suggestions for improvement	Change from baseline at 8 weeks and 1 week post intervention	Assessed by qualitative interview looking at likes and dislikes of the training program as well as suggestions for improvement
Adherence	Change from baseline at 8 weeks and 1 week post intervention	Percent of prescribed exercise completed across sessions
Compliance	Change from baseline at 8 weeks and 1 week post intervention	Percent of exercise sessions completed
Tracking adverse events	During training session	Adverse events are event that occurs during the course of exercise training that cause the participant physical or psychological harm

Secondary Outcome Measures

Name	Time	Method
Body mass composition absolute values	Change from baseline at 8 weeks and 1 week post intervention	Lean body mass (kg), fat body mass (kg), bone mineral content (kg), total mass (kg) all measured by Dual X-ray Absorptiometry scan
Physical activity levels	Change from baseline at 8 weeks and 1 week post intervention	Time spent in physical activity (at light, moderate and high intensity) and sedentary time (min\*day-1) measured by a waist-worn accelerometer
Inflammatory cytokine levels	Change from baseline at 8 weeks and 1 week post intervention	IL-6 and TNF-alpha concentrations (pg/ml) measured from patient plasma by enzyme-linked immunosorbent assays
Aerobic fitness: maximum rate of oxygen consumption attainable during physical exertion	Change from baseline at 8 weeks and 1 week post intervention	VO2 peak (L\*min-1) measured by the McMaster All-Out Progressive Continuous Cycling Test using a calibrated metabolic cart
Aerobic fitness: peak workload	Change from baseline at 8 weeks and 1 week post intervention	peak workload (watts) measured by the McMaster All-Out Progressive Continuous Cycling Test using a cycle ergometer
Aerobic fitness: peak heart rate	Change from baseline at 8 weeks and 1 week post intervention	Peak heart rate (beats\*min-1), measured by the McMaster All-Out Progressive Continuous Cycling Test using heart rate monitor
Body mass composition as a percent of total body mass	Change from baseline at 8 weeks and 1 week post intervention	Lean body mass (% of total mass), fat body mass (% of total mass), bone mineral content (% of total mass). Absolute body composition measures (kg) divided by total body mass (kg) make % of total mass. All measured by Dual X-ray Absorptiometry scan.
Muscle strength	Change from baseline at 8 weeks and 1 week post intervention	Grip strength (Nm), isokinetic and isometric leg strength (Nm) and isokinetic and isometric arm strength (Nm) all measured with an isokinetic dynamometer
Bone mineral density	Change from baseline at 8 weeks and 1 week post intervention	Bone mineral density (g/cm\^3) measured by Dual X-ray Absorptiometry scan.

Trial Locations

Locations (1)

McMaster Children's Hospital; 🇨🇦 Hamilton, ONT, Canada