Condition category
Musculoskeletal Diseases
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
19/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr R.H.H. Engelbert

ORCID ID

Contact details

KB 02.056.0
3508 AB
P.O. Box 85090
Utrecht
3584 EA
Netherlands
+31 (0)30 2504030
r.engelbert@umcutrecht.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

04/331-k (METC UMCU)

Study information

Scientific title

Acronym

ETOI

Study hypothesis

Children with Osteogenesis Imperfecta type I and IV would benefit from a gradual training program. Increased exercise capacity and muscle strength could increase quality of life.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Multicentre, randomised, single-blinded, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Osteogenesis Imperfecta

Intervention

Training program for 12 weeks (two times/week).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Exercise capacity and muscle strength.

Secondary outcome measures

Health related quality of life.

Overall trial start date

02/02/2005

Overall trial end date

02/08/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Osteogenesis Imperfecta Type I and IV
2. Between 8 and 18 years of age
3. Ambulatory

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

36

Participant exclusion criteria

1. Osteogenesis Imperfecta type II and III
2. Retardation
3. Non-walking

Recruitment start date

02/02/2005

Recruitment end date

02/08/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

KB 02.056.0, 3508 AB
Utrecht
3584 EA
Netherlands

Sponsor information

Organisation

University Medical Centre Utrecht (UMCU) (Netherlands)

Sponsor details

P.O. Box 85500
Utrecht
3508 GA
Netherlands

Sponsor type

University/education

Website

http://www.umcutrecht.nl/zorg/

Funders

Funder type

Charity

Funder name

Johanna Child Fund (Johanna Kinderfonds) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Foundation for paediatric rehabilitation (Stichting Bio-Kinderrevalidatie) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/18154911

Publication citations

  1. Results

    Van Brussel M, Takken T, Uiterwaal CS, Pruijs HJ, Van der Net J, Helders PJ, Engelbert RH, Physical training in children with osteogenesis imperfecta., J. Pediatr., 2008, 152, 1, 111-6, 116.e1, doi: 10.1016/j.jpeds.2007.06.029.

Additional files

Editorial Notes