Pediatric Inflammatory Bowel Diseases, Pediatric Crohns Disease, Pediatric Ulcerative Colitis
Conditions
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.
Interventions
16-week, structured exercise training program including resistance and aerobic exercise
Sponsors
McMaster University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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) |
| 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) |
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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. |
| 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. |
| 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 |
| 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 |
| 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 |
Countries
Canada
Outcome results
None listed