Exercise Training in Youth With Inflammatory Bowel Disease

Pediatric Crohns Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05591976
• Other study ID #: 13-194
• Status: Completed
• Phase: N/A
• Start date: May 1, 2013
• Est. completion date: June 1, 2014

Study information

• Verified date: October 2022
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: June 1, 2014
• Est. primary completion date: June 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Pediatric Crohns Disease
• Pediatric Ulcerative Colitis

Intervention

Other:
• Exercise training program
16-week, structured exercise training program including resistance and aerobic exercise

Locations

Country	Name	City	State
Canada	McMaster Children's Hospital	Hamilton	ONT

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment	Measure of patient recruitment (number of patients approached, enrolled, refused)	Change from baseline at 8 weeks and 1 week post intervention
Primary	Retention	Percent of patients that completed the study after enrolment	Change from baseline at 8 weeks and 1 week post intervention
Primary	Adherence	Percent of prescribed exercise completed across sessions	Change from baseline at 8 weeks and 1 week post intervention
Primary	Compliance	Percent of exercise sessions completed	Change from baseline at 8 weeks and 1 week post intervention
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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