Exercise Training in Youth With Inflammatory Bowel Disease

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

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.

Study Overview

• Status: Completed
• Conditions: Pediatric Ulcerative Colitis; Pediatric Crohns Disease; Pediatric Inflammatory Bowel Diseases
• Intervention / Treatment: Other: Exercise training program

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • ONT
    • Hamilton, ONT, Canada, L8S4L8
      • McMaster Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise group; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: McMaster University
• Investigators: Principal Investigator: Brian Timmons, PhD, McMaster University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: September 20, 2022
• First Submitted That Met QC Criteria: October 20, 2022
• First Posted (Actual): October 24, 2022

Study Record Updates

• Last Update Posted (Actual): October 24, 2022
• Last Update Submitted That Met QC Criteria: October 20, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases
• Other Study ID Numbers: 13-194

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No