An interventional study of Exercise training program in Pediatric Inflammatory Bowel Diseases, Pediatric Crohns Disease and Pediatric Ulcerative Colitis, sponsored by McMaster University. Completed at 1 site in Canada. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2022-10-24.
Sponsored by McMaster University · Not applicable, Interventional, and Supportive care
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.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's enrollment of 11 is below the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →McMaster University is the lead sponsor of 720 studies on the registry; 124 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants are assessed for outcomes prior to intervention, mid-way through intervention and immediately after intervention.
Other: Exercise training program
16-week, structured exercise training program including resistance and aerobic exercise
Recruitment
Measure of patient recruitment (number of patients approached, enrolled, refused)
Time frame: Change from baseline at 8 weeks and 1 week post intervention
Retention
Percent of patients that completed the study after enrolment
Time frame: Change from baseline at 8 weeks and 1 week post intervention
Adherence
Percent of prescribed exercise completed across sessions
Time frame: Change from baseline at 8 weeks and 1 week post intervention
Compliance
Percent of exercise sessions completed
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: During training session
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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change from baseline at 8 weeks and 1 week post intervention
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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