Exercise Training in Youth With Inflammatory Bowel Disease

Study Overview
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Brief Summary
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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.

Official Title
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The Effects of Exercise Training on Fitness, Function and Quality of Life in Youth With Inflammatory Bowel Disease: A Pilot Study

Conditions
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Pediatric Inflammatory Bowel Diseases, Pediatric Crohns Disease, Pediatric Ulcerative Colitis

Intervention / Treatment
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* Other: Exercise training program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise group<br>Participants are assessed for outcomes prior to intervention, mid-way through intervention and immediately after intervention. | Other: Exercise training program<br>* 16-week, structured exercise training program including resistance and aerobic exercise<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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