Exercise Training in Youth With Inflammatory Bowel Disease

NCT05591976 | Completed

• 1 other identifier: 13-194
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Inflammatory Bowel Diseases; Pediatric Crohns Disease; Pediatric Ulcerative Colitis

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (9)

• Body mass composition absolute values

  Change from baseline at 8 weeks and 1 week post intervention

• Body mass composition as a percent of total body mass

  Change from baseline at 8 weeks and 1 week post intervention

• Bone mineral density

  Change from baseline at 8 weeks and 1 week post intervention

• Aerobic fitness: maximum rate of oxygen consumption attainable during physical exertion

  Change from baseline at 8 weeks and 1 week post intervention

• Aerobic fitness: peak workload

  Change from baseline at 8 weeks and 1 week post intervention

Study Arms (1)

Exercise group

EXPERIMENTAL

Participants are assessed for outcomes prior to intervention, mid-way through intervention and immediately after intervention.

Other: Exercise training program

Interventions

Exercise training program OTHER

16-week, structured exercise training program including resistance and aerobic exercise

Exercise group

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Children who exercise train 3 times a week of more

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster Children's Hospital

Hamilton, Ontario, L8S4L8, Canada

Location

MeSH Terms

Conditions

Pediatric ulcerative colitis

Study Officials

• Brian Timmons, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: October 24, 2022
• Study Start: May 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: October 24, 2022

Record last verified: 2022-10

Locations

CA (1)