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Completed

NCT Number: NCT05591976

Exercise Training in Youth With Inflammatory Bowel Disease

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.

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Key information

Conditions

Pediatric Inflammatory Bowel Diseases Pediatric Crohns Disease Pediatric Ulcerative Colitis

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster Children's Hospital

Hamilton, Ontario, L8S4L8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise training program

Other

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

Primary outcomes

  1. Recruitment

    Time frame: Change from baseline at 8 weeks and 1 week post intervention

    Measure of patient recruitment (number of patients approached, enrolled, refused)

  2. Retention

    Time frame: Change from baseline at 8 weeks and 1 week post intervention

    Percent of patients that completed the study after enrolment

  3. Adherence

    Time frame: Change from baseline at 8 weeks and 1 week post intervention

    Percent of prescribed exercise completed across sessions

  4. Compliance

    Time frame: Change from baseline at 8 weeks and 1 week post intervention

    Percent of exercise sessions completed

  5. Changes in IBD-related symptoms: Pediatric Ulcerative Colitis Activity Index

    Time frame: Change from baseline at 8 weeks and 1 week post intervention

    Tracking changes in IBD-related symptoms based on Pediatric Ulcerative Colitis Activity Index (scored 0-85, where higher score indicates more severe disease)

  6. Changes in IBD-related symptoms: Pediatric Crohn's Disease Activity Index

    Time frame: Change from baseline at 8 weeks and 1 week post intervention

    Tracking changes in IBD-related symptoms based on Pediatric Crohn's Disease Activity Index (scored 0-100, where higher score indicates more severe disease)

  7. Qualitative assessment of participant likes and dislikes of the training program and suggestions for improvement

    Time frame: Change from baseline at 8 weeks and 1 week post intervention

    Assessed by qualitative interview looking at likes and dislikes of the training program as well as suggestions for improvement

  8. Tracking adverse events

    Time frame: During training session

    Adverse events are event that occurs during the course of exercise training that cause the participant physical or psychological harm

Secondary outcomes

  1. Body mass composition absolute values

    Time frame: Change from baseline at 8 weeks and 1 week post intervention

    Lean body mass (kg), fat body mass (kg), bone mineral content (kg), total mass (kg) all measured by Dual X-ray Absorptiometry scan

  2. Body mass composition as a percent of total body mass

    Time frame: Change from baseline at 8 weeks and 1 week post intervention

    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.

  3. Bone mineral density

    Time frame: Change from baseline at 8 weeks and 1 week post intervention

    Bone mineral density (g/cm^3) measured by Dual X-ray Absorptiometry scan.

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

    Time frame: Change from baseline at 8 weeks and 1 week post intervention

    VO2 peak (L*min-1) measured by the McMaster All-Out Progressive Continuous Cycling Test using a calibrated metabolic cart

  5. Aerobic fitness: peak workload

    Time frame: Change from baseline at 8 weeks and 1 week post intervention

    peak workload (watts) measured by the McMaster All-Out Progressive Continuous Cycling Test using a cycle ergometer

  6. Aerobic fitness: peak heart rate

    Time frame: Change from baseline at 8 weeks and 1 week post intervention

    Peak heart rate (beats*min-1), measured by the McMaster All-Out Progressive Continuous Cycling Test using heart rate monitor

  7. Muscle strength

    Time frame: Change from baseline at 8 weeks and 1 week post intervention

    Grip strength (Nm), isokinetic and isometric leg strength (Nm) and isokinetic and isometric arm strength (Nm) all measured with an isokinetic dynamometer

  8. Physical activity levels

    Time frame: Change from baseline at 8 weeks and 1 week post intervention

    Time spent in physical activity (at light, moderate and high intensity) and sedentary time (min*day-1) measured by a waist-worn accelerometer

  9. Inflammatory cytokine levels

    Time frame: Change from baseline at 8 weeks and 1 week post intervention

    IL-6 and TNF-alpha concentrations (pg/ml) measured from patient plasma by enzyme-linked immunosorbent assays

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 24, 2022
Registry last updated
Oct 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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