Clinical trial NCT05591976: Exercise Training in Youth With Inflammatory Bowel Disease
Official title: The Effects of Exercise Training on Fitness, Function and Quality of Life in Youth With Inflammatory Bowel Disease: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Inflammatory Bowel Diseases
Pediatric Crohns Disease
Pediatric Ulcerative Colitis
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2022-10-24
Enrollment: 11
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Recruitment
timeFrame: Change from baseline at 8 weeks and 1 week post intervention
measure: Retention
timeFrame: Change from baseline at 8 weeks and 1 week post intervention
measure: Adherence
timeFrame: Change from baseline at 8 weeks and 1 week post intervention
measure: Compliance
timeFrame: Change from baseline at 8 weeks and 1 week post intervention
measure: Changes in IBD-related symptoms: Pediatric Ulcerative Colitis Activity Index
timeFrame: Change from baseline at 8 weeks and 1 week post intervention
measure: Changes in IBD-related symptoms: Pediatric Crohn's Disease Activity Index
timeFrame: Change from baseline at 8 weeks and 1 week post intervention
measure: Qualitative assessment of participant likes and dislikes of the training program and suggestions for improvement
timeFrame: Change from baseline at 8 weeks and 1 week post intervention
measure: Tracking adverse events
timeFrame: During training session
Secondary outcomes:
measure: Body mass composition absolute values
timeFrame: Change from baseline at 8 weeks and 1 week post intervention
measure: Body mass composition as a percent of total body mass
timeFrame: Change from baseline at 8 weeks and 1 week post intervention
measure: Bone mineral density
timeFrame: Change from baseline at 8 weeks and 1 week post intervention
measure: Aerobic fitness: maximum rate of oxygen consumption attainable during physical exertion
timeFrame: Change from baseline at 8 weeks and 1 week post intervention
measure: Aerobic fitness: peak workload
timeFrame: Change from baseline at 8 weeks and 1 week post intervention
measure: Aerobic fitness: peak heart rate
timeFrame: Change from baseline at 8 weeks and 1 week post intervention
measure: Muscle strength
timeFrame: Change from baseline at 8 weeks and 1 week post intervention
measure: Physical activity levels
timeFrame: Change from baseline at 8 weeks and 1 week post intervention
measure: Inflammatory cytokine levels
timeFrame: Change from baseline at 8 weeks and 1 week post intervention
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: ONT
Study officials:
affiliation: McMaster University
name: Brian Timmons, PhD
role: PRINCIPAL_INVESTIGATOR
References: