Influence of Aerobic Exercise Training (AET) on Inflammatory Bowel Disease (IBD) in Children and Adolescents

NCT ID: NCT02264275

Last Updated: 2014-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Ulcerative Colitis Crohn Disease Depression Sleep Quality of Life Motor Activity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Aerobic Exercise Training

An 8-week Nintendo Wii at-home dancing exergame Intervention

Group Type EXPERIMENTAL

Aerobic Exercise Training

Intervention Type BEHAVIORAL

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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Aerobic Exercise Training

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).

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Nintendo Wii Exergame Dance Videogame

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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)

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

7 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Children's Hospital Basel

OTHER

Sponsor Role collaborator

Psychiatric Hospital of the University of Basel

OTHER

Sponsor Role collaborator

University of Basel

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Catherine Elliot

Dr. Catherine Elliot

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Catherine A Elliot, Dr. phil.

Role: PRINCIPAL_INVESTIGATOR

University of Basel

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universitäre Psychiatrische Kliniken Basel (UPK)

Basel, Canton of Basel-City, Switzerland

Site Status RECRUITING

Universitäts-Kinderspital beider Basel (UKBB)

Basel, Canton of Basel-City, Switzerland

Site Status RECRUITING

Universität Basel (Departement für Sport, Bewegung und Gesundheit)

Basel, Canton of Basel-City, Switzerland

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Catherine A Elliot, Dr. phil.

Role: CONTACT

0041 (0)61 377 87 80

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Serge Brand, PD Dr. med.

Role: primary

061 325 51 14

Raoul Furlano, Dr. med.

Role: primary

+ 41 (0)61 704 2905

Markus Gerber, PD Dr. phil

Role: primary

061 377 87 83

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 29233119 (View on PubMed)

Mahlmann 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.

Reference Type DERIVED
PMID: 29157584 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://dsbg.unibas.ch/

University of Basel, Department for Sport, Exercise and Health

http://www.ukbb.ch/

University of Basel Childrens Hospital

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DSBG-UniBasel-Ex-CED-2014-220

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Managing Inflammatory Bowel Disease
NCT00679003 COMPLETED NA