Ulcerative ColitisEx-CEDNCT02264275
Influence of Aerobic Exercise Training (AET) on Inflammatory Bowel Disease (IBD) in Children and Adolescents
A study testing Aerobic Exercise Training in people with Ulcerative Colitis and Crohn Disease, run by University of Basel at 3 sites in Switzerland.
Trial summary
The purpose of this study is to determine if aerobic exercise training can serve as comprehensive palliative care, whereby enhancing cardiovascular fitness, mitigating depressive symptoms and augmenting sleep while bolstering health related quality of life in youth with Crohn's Disease and Ulcerative Colitis. Read more about this study
- Who is it for?
- Ages 7 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis, Crohn Disease, Depression
- What is being tested?
- Aerobic Exercise Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesSwitzerland
- Study dates
- Oct 2014to Mar 2015
- 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 7 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- aged 7 through 20 at start of study
- willing and able to volunteer in the study
- able to communicate and to complete questionnaires in German
- have a functioning television with Nintendo Wii compatibility at home
- provide participant written informed consent (when ≥11 years old at start of study)
- provide parental/legal caregiver written informed consent (when participant is ≤17 years old at start of study)
- provide oral informed consent (when ≤10 years old at start of study)
Who cannot join
- refusal to give necessary oral or written informed consent by patient and/or parent (legal caregiver)
- not aged 7 through 20 at start of study
- not willing and able to volunteer in the study
- has sibling enrolled in this study
- has severe physical diseases of the locomotor apparatus, psychotic disorders, severe affective disorders, eating disorders, mental retardation, autism spectrum disorder
- inability to communicate and complete questionnaires in German
Show all 10Show fewer
- does not own a functional and Nintendo Wii-compatible television at home
- among female adolescents, pregnancy, breastfeeding or intention to get pregnant during the study
- has clinically significant cardiovascular disease
- enrolment of the investigator, his/her family members, employees and other dependent persons
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites, 3 recruiting
- Recruiting
Universitäre Psychiatrische Kliniken Basel (UPK)
Basel, Canton of Basel-City, 4012
Serge Brand, PD Dr. med., 061 325 51 14, serge.brand@upkbs.ch
- Recruiting
Universitäts-Kinderspital beider Basel (UKBB)
Basel, Canton of Basel-City, 4031
Raoul Furlano, Dr. med., + 41 (0)61 704 2905, raoul.furlano@ukbb.ch
Raoul Furlano, Dr. med.
- Recruiting
Universität Basel (Departement für Sport, Bewegung und Gesundheit)
Basel, Canton of Basel-City, 4052
Markus Gerber, PD Dr. phil, 061 377 87 83, markus.gerber@unibas.ch
Catherine Elliot, Dr. phil.
About this study
Official title: The Influence of Aerobic Exercise Training on Disease Symptoms, Cardiovascular Fitness, Depression, Sleep and Quality of Life in Children and Adolescents Suffering From Inflammatory Bowel Disease in Switzerland
The purpose of this study is to determine if aerobic exercise training can serve as comprehensive palliative care, whereby enhancing cardiovascular fitness, mitigating depressive symptoms and augmenting sleep while bolstering health related quality of life in youth with Crohn's Disease and Ulcerative Colitis.
Read the detailed description
An AET intervention is designed to increase the aerobic fitness levels of IBD sufferers through daily activity, which is notably lower in this population and could be beneficial for sufferers managing this lifelong disease. With an increase in physical activity, the exergame aims to introduce, instill and integrate daily physical activity in the lives of IBD sufferers. The Just Dance Kids exergame for Nintendo Wii employs moderate intensity physical activity and is well suited for this study. The exergame intervention protocol will comprise a ramped duration aerobic exercise training starting with 10 minutes in week 1 and rises to 30 minutes per session in weeks 5 through 8. Just Dance Kids will be used by participants under the age of 11 and Just Dance for participants over the age of 10 due to the age appropriate dancing skill required in each game. The aim is to determine if this moderate intensity, 5 times per week exercise could decrease IBD flare-ups, improve cardiovascular fitness, reduce depressive symptoms, improve quality and quantity of sleep and improve the health-related quality of life in children and adolescents with IBD.
- Conditions
- Ulcerative Colitis, Crohn Disease, Depression, Sleep, Quality of Life, Motor Activity
- Being tested
- Aerobic Exercise Training
- Keywords
- Aerobic Exercise, Exercise, Exergame, Behavior, Video Game, Inflammatory Bowel Disease, Children, Adolescents, Pediatric, Physical Fitness
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease, Depression, Motor Activity, Behavior, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Exercise TrainingBehavioural
Also called Nintendo Wii, Exergame, Dance Videogame
The aerobic exercise training uses a television attached to a Nintendo Wii videogame console with a dance game to be played by participants on 5 days per week using a ramped-duration schedule (from 10-30 minutes of moderate physical activity daily).
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise Training | Experimental | An 8-week Nintendo Wii at-home dancing exergame Intervention Receives: Behavioral: Aerobic Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Disease Activity Index
Uses either Crohn's Disease or Ulcerative Colitis Disease Activity Index respective to the patient's disease
Measured: 8 Weeks
Secondary outcomes (4)
Sleep
Uses Insomnia Severity Index and Daily Sleep Log
Measured: 8 Weeks
Depressive Symptomology
Uses Child-S or Des-Teen with respect to participants age
Measured: 8 Weeks
Health Related Quality of Life
KIDSCREEN-27
Measured: 8 Weeks
Estimation of Vo2Max
Uses the Astrand-Rhyming cycle ergometer protocol
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionFeb 2015 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Basel
- Sponsor type
- University, hospital or other
- Collaborators
- University Children's Hospital Basel, Psychiatric Hospital of the University of Basel
- Responsible party
- Principal investigator, Catherine Elliot, University of Basel
- Investigators
- Catherine A Elliot, Dr. phil., Principal investigator, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02264275
- Sponsor's protocol ID
- DSBG-UniBasel-Ex-CED-2014-220
- Acronym
- Ex-CED
- Status last verified
- Oct 2014
- First submitted
- 8 Oct 2014
- Last updated
- 21 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mahlmann L, Gerber M, Furlano RI, Legeret C, Kalak N, Holsboer-Trachsler E, Brand S. Psychological wellbeing and physical activity in children and adolescents with inflammatory bowel disease compared to healthy controls. BMC Gastroenterol. 2017 Dec 12;17(1):160. doi: 10.1186/s12876-017-0721-7.
PubMed 29233119Mahlmann L, Gerber M, Furlano RI, Legeret C, Kalak N, Holsboer-Trachsler E, Brand S. Impaired objective and subjective sleep in children and adolescents with inflammatory bowel disease compared to healthy controls. Sleep Med. 2017 Nov;39:25-31. doi: 10.1016/j.sleep.2017.08.015. Epub 2017 Sep 21.
PubMed 29157584
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Aerobic Exercise Training on Disease Symptoms, Cardiovascular Fitness, Depression, Sleep and Quality of Life in Children and Adolescents Suffering From Inflammatory Bowel Disease in Switzerland
- ClinicalTrials.gov ID
- NCT02264275
- Acronym / sponsor ID
- Ex-CED / DSBG-UniBasel-Ex-CED-2014-220
- Conditions
- Ulcerative Colitis, Crohn Disease, Depression, Sleep, Quality of Life, Motor Activity
- Keywords
- Aerobic Exercise, Exercise, Exergame, Behavior, Video Game, Inflammatory Bowel Disease, Children, Adolescents
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of BaselUniversity, hospital or other
- Collaborators
- University Children's Hospital Basel, Psychiatric Hospital of the University of Basel
- Study start
- Oct 2014
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 15 Oct 2014 (estimated)
- 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.
The purpose of this study is to determine if aerobic exercise training can serve as comprehensive palliative care, whereby enhancing cardiovascular fitness, mitigating depressive symptoms and augmenting sleep while bolstering health related quality of life in youth with Crohn's Disease and Ulcerative Colitis.
Detailed description
An AET intervention is designed to increase the aerobic fitness levels of IBD sufferers through daily activity, which is notably lower in this population and could be beneficial for sufferers managing this lifelong disease. With an increase in physical activity, the exergame aims to introduce, instill and integrate daily physical activity in the lives of IBD sufferers. The Just Dance Kids exergame for Nintendo Wii employs moderate intensity physical activity and is well suited for this study. The exergame intervention protocol will comprise a ramped duration aerobic exercise training starting with 10 minutes in week 1 and rises to 30 minutes per session in weeks 5 through 8. Just Dance Kids will be used by participants under the age of 11 and Just Dance for participants over the age of 10 due to the age appropriate dancing skill required in each game. The aim is to determine if this moderate intensity, 5 times per week exercise could decrease IBD flare-ups, improve cardiovascular fitness, reduce depressive symptoms, improve quality and quantity of sleep and improve the health-related quality of life in children and adolescents 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 |
|---|---|---|
| Aerobic Exercise Training | Experimental | Behavioral: Aerobic Exercise TrainingAn 8-week Nintendo Wii at-home dancing exergame Intervention |
Who may qualify
- Ages
- 7 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- aged 7 through 20 at start of study
- willing and able to volunteer in the study
- able to communicate and to complete questionnaires in German
- have a functioning television with Nintendo Wii compatibility at home
- provide participant written informed consent (when ≥11 years old at start of study)
Key exclusion criteria (10 listed)
- refusal to give necessary oral or written informed consent by patient and/or parent (legal caregiver)
- not aged 7 through 20 at start of study
- not willing and able to volunteer in the study
- has sibling enrolled in this study
- has severe physical diseases of the locomotor apparatus, psychotic disorders, severe affective disorders, eating disorders, mental retardation, autism spectrum disorder
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 |
|---|---|---|
| Aerobic Exercise TrainingAlso: Nintendo Wii, Exergame, Dance VideogameThe aerobic exercise training uses a television attached to a Nintendo Wii videogame console with a dance game to be played by participants on 5 days per week using a ramped-duration schedule (from 10-30 minutes of moderate physical activity daily). | Behavioural | Aerobic Exercise Training |
Primary outcome
Pediatric Disease Activity Index
Time frame: 8 Weeks
Uses either Crohn's Disease or Ulcerative Colitis Disease Activity Index respective to the patient's disease
4 secondary outcomes
Sleep
Time frame: 8 Weeks
Depressive Symptomology
Time frame: 8 Weeks
Health Related Quality of Life
Time frame: 8 Weeks
Estimation of Vo2Max
Time frame: 8 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2014.
- Derived from this study: PubMed 29233119Mahlmann L, Gerber M, Furlano RI, Legeret C, Kalak N, Holsboer-Trachsler E, Brand S. Psychological wellbeing and physical activity in children and adolescents with inflammatory bowel disease compared to healthy controls. BMC Gastroenterol. 2017 Dec 12;17(1):160. doi: 10.1186/s12876-017-0721-7.
- Derived from this study: PubMed 29157584Mahlmann L, Gerber M, Furlano RI, Legeret C, Kalak N, Holsboer-Trachsler E, Brand S. Impaired objective and subjective sleep in children and adolescents with inflammatory bowel disease compared to healthy controls. Sleep Med. 2017 Nov;39:25-31. doi: 10.1016/j.sleep.2017.08.015. Epub 2017 Sep 21.
- University of Basel, Department for Sport, Exercise and HealthLink provided by the sponsor.
- University of Basel Childrens HospitalLink provided by the sponsor.
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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.
Catherine A Elliot, Dr. phil. principal investigator
University of Basel
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise Training in people with Ulcerative Colitis and Crohn Disease, run by University of Basel at 3 sites in Switzerland.
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 7 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 21 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catherine A Elliot, Dr. phil. (0041 (0)61 377 87 80, catherine.elliot@unibas.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Disease Activity Index (time frame: 8 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02264275, which also lists 2 linked publications.
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 21 Oct 2014.