Pediatric Inflammatory Bowel DiseasesNCT05591976
Exercise Training in Youth With Inflammatory Bowel Disease
A study testing Exercise training program in people with Pediatric Inflammatory Bowel Diseases and Pediatric Crohns Disease, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Pediatric Inflammatory Bowel Diseases, Pediatric Crohns Disease, Pediatric Ulcerative Colitis
- What is being tested?
- Exercise training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2013to 1 Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Children who exercise train 3 times a week of more
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Pediatric Inflammatory Bowel Diseases, Pediatric Crohns Disease, Pediatric Ulcerative Colitis
- Being tested
- Exercise training program
- Medical subject headings
- Pediatric ulcerative colitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise training programOther
16-week, structured exercise training program including resistance and aerobic exercise
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Participants are assessed for outcomes prior to intervention, mid-way through intervention and immediately after intervention. Receives: Other: Exercise training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Measure of patient recruitment (number of patients approached, enrolled, refused)
Measured: Change from baseline at 8 weeks and 1 week post intervention
Retention
Percent of patients that completed the study after enrolment
Measured: Change from baseline at 8 weeks and 1 week post intervention
Adherence
Percent of prescribed exercise completed across sessions
Measured: Change from baseline at 8 weeks and 1 week post intervention
Compliance
Percent of exercise sessions completed
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: During training session
Secondary outcomes (9)
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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Change from baseline at 8 weeks and 1 week post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start1 May 2013
- Primary completion1 Jun 2014
- Study completion1 Jun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Timmons, McMaster University
- Investigators
- Brian Timmons, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05591976
- Sponsor's protocol ID
- 13-194
- Status last verified
- Oct 2022
- First submitted
- 20 Sep 2022
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Exercise Training on Fitness, Function and Quality of Life in Youth With Inflammatory Bowel Disease: A Pilot Study
- ClinicalTrials.gov ID
- NCT05591976
- Acronym / sponsor ID
- 13-194
- Conditions
- Pediatric Inflammatory Bowel Diseases, Pediatric Crohns Disease, Pediatric Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 May 2013 (actual)
- Primary completion
- 1 Jun 2014 (actual)
- Study completion
- 1 Jun 2014 (actual)
- First posted
- 24 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: Exercise training programParticipants are assessed for outcomes prior to intervention, mid-way through intervention and immediately after intervention. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Children who exercise train 3 times a week of more
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise training program16-week, structured exercise training program including resistance and aerobic exercise | Other | Exercise group |
Primary outcome
Recruitment
Time frame: Change from baseline at 8 weeks and 1 week post intervention
Measure of patient recruitment (number of patients approached, enrolled, refused)
Retention
Time frame: Change from baseline at 8 weeks and 1 week post intervention
Percent of patients that completed the study after enrolment
Adherence
Time frame: Change from baseline at 8 weeks and 1 week post intervention
Percent of prescribed exercise completed across sessions
Compliance
Time frame: Change from baseline at 8 weeks and 1 week post intervention
Percent of exercise sessions completed
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)
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)
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
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
9 secondary outcomes
Body mass composition absolute values
Time frame: Change from baseline at 8 weeks and 1 week post intervention
Body mass composition as a percent of total body mass
Time frame: Change from baseline at 8 weeks and 1 week post intervention
Bone mineral density
Time frame: Change from baseline at 8 weeks and 1 week post intervention
Aerobic fitness: maximum rate of oxygen consumption attainable during physical exertion
Time frame: Change from baseline at 8 weeks and 1 week post intervention
Aerobic fitness: peak workload
Time frame: Change from baseline at 8 weeks and 1 week post intervention
Aerobic fitness: peak heart rate
Time frame: Change from baseline at 8 weeks and 1 week post intervention
Muscle strength
Time frame: Change from baseline at 8 weeks and 1 week post intervention
Physical activity levels
Time frame: Change from baseline at 8 weeks and 1 week post intervention
Inflammatory cytokine levels
Time frame: Change from baseline at 8 weeks and 1 week post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Timmons, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training program in people with Pediatric Inflammatory Bowel Diseases and Pediatric Crohns Disease, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: Change from baseline at 8 weeks and 1 week post intervention). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2022.