Exercise Training in Youth With Inflammatory Bowel Disease
Primary Purpose
Pediatric Inflammatory Bowel Diseases, Pediatric Crohns Disease, Pediatric Ulcerative Colitis
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise training program
Sponsored by
About this trial
This is an interventional supportive care trial for Pediatric Inflammatory Bowel Diseases
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
Sites / Locations
- McMaster Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Exercise group
Arm Description
Participants are assessed for outcomes prior to intervention, mid-way through intervention and immediately after intervention.
Outcomes
Primary Outcome Measures
Recruitment
Measure of patient recruitment (number of patients approached, enrolled, refused)
Retention
Percent of patients that completed the study after enrolment
Adherence
Percent of prescribed exercise completed across sessions
Compliance
Percent of exercise sessions completed
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)
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)
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
Tracking adverse events
Adverse events are event that occurs during the course of exercise training that cause the participant physical or psychological harm
Secondary Outcome Measures
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
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.
Bone mineral density
Bone mineral density (g/cm^3) measured by Dual X-ray Absorptiometry scan.
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
Aerobic fitness: peak workload
peak workload (watts) measured by the McMaster All-Out Progressive Continuous Cycling Test using a cycle ergometer
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
Muscle strength
Grip strength (Nm), isokinetic and isometric leg strength (Nm) and isokinetic and isometric arm strength (Nm) all measured with an isokinetic dynamometer
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
Inflammatory cytokine levels
IL-6 and TNF-alpha concentrations (pg/ml) measured from patient plasma by enzyme-linked immunosorbent assays
Full Information
NCT ID
NCT05591976
First Posted
September 20, 2022
Last Updated
October 20, 2022
Sponsor
McMaster University
1. Study Identification
Unique Protocol Identification Number
NCT05591976
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2013 (Actual)
Primary Completion Date
June 1, 2014 (Actual)
Study Completion Date
June 1, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Inflammatory Bowel Diseases, Pediatric Crohns Disease, Pediatric Ulcerative Colitis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise group
Arm Type
Experimental
Arm Description
Participants are assessed for outcomes prior to intervention, mid-way through intervention and immediately after intervention.
Intervention Type
Other
Intervention Name(s)
Exercise training program
Intervention Description
16-week, structured exercise training program including resistance and aerobic exercise
Primary Outcome Measure Information:
Title
Recruitment
Description
Measure of patient recruitment (number of patients approached, enrolled, refused)
Time Frame
Change from baseline at 8 weeks and 1 week post intervention
Title
Retention
Description
Percent of patients that completed the study after enrolment
Time Frame
Change from baseline at 8 weeks and 1 week post intervention
Title
Adherence
Description
Percent of prescribed exercise completed across sessions
Time Frame
Change from baseline at 8 weeks and 1 week post intervention
Title
Compliance
Description
Percent of exercise sessions completed
Time Frame
Change from baseline at 8 weeks and 1 week post intervention
Title
Changes in IBD-related symptoms: Pediatric Ulcerative Colitis Activity Index
Description
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
Title
Changes in IBD-related symptoms: Pediatric Crohn's Disease Activity Index
Description
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
Title
Qualitative assessment of participant likes and dislikes of the training program and suggestions for improvement
Description
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
Title
Tracking adverse events
Description
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
Secondary Outcome Measure Information:
Title
Body mass composition absolute values
Description
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
Title
Body mass composition as a percent of total body mass
Description
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
Title
Bone mineral density
Description
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
Title
Aerobic fitness: maximum rate of oxygen consumption attainable during physical exertion
Description
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
Title
Aerobic fitness: peak workload
Description
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
Title
Aerobic fitness: peak heart rate
Description
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
Title
Muscle strength
Description
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
Title
Physical activity levels
Description
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
Title
Inflammatory cytokine levels
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Timmons, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster Children's Hospital
City
Hamilton
State/Province
ONT
ZIP/Postal Code
L8S4L8
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Exercise Training in Youth With Inflammatory Bowel Disease
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