Intervention project Osteogenesis Imperfecta (OI) type I and IV: home based training program to increase exercise capacity, muscle strength and aspects of quality of life in children with Osteogenesis Imperfecta
| ISRCTN | ISRCTN28577651 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28577651 |
| Secondary identifying numbers | 04/331-k (METC UMCU) |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 19/03/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr R.H.H. Engelbert
Scientific
Scientific
KB 02.056.0, 3508 AB
P.O. Box 85090
Utrecht
3584 EA
Netherlands
| Phone | +31 (0)30 2504030 |
|---|---|
| r.engelbert@umcutrecht.nl |
Study information
| Study design | Multicentre, randomised, single-blinded, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | ETOI |
| Study objectives | 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(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Osteogenesis Imperfecta |
| Intervention | Training program for 12 weeks (two times/week). |
| Intervention type | Other |
| Primary outcome measure | Exercise capacity and muscle strength. |
| Secondary outcome measures | Health related quality of life. |
| Overall study start date | 02/02/2005 |
| Completion date | 02/08/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 8 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 36 |
| Key inclusion criteria | 1. Osteogenesis Imperfecta Type I and IV 2. Between 8 and 18 years of age 3. Ambulatory |
| Key exclusion criteria | 1. Osteogenesis Imperfecta type II and III 2. Retardation 3. Non-walking |
| Date of first enrolment | 02/02/2005 |
| Date of final enrolment | 02/08/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
KB 02.056.0, 3508 AB
Utrecht
3584 EA
Netherlands
3584 EA
Netherlands
Sponsor information
University Medical Centre Utrecht (UMCU) (Netherlands)
University/education
University/education
PO Box 85500
Utrecht
3508 GA
Netherlands
| Website | http://www.umcutrecht.nl/zorg/ |
|---|---|
"ROR" |
https://ror.org/04pp8hn57 |
Funders
Funder type
Charity
Johanna Child Fund (Johanna Kinderfonds) (The Netherlands)
No information available
Foundation for paediatric rehabilitation (Stichting Bio-Kinderrevalidatie) (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/01/2008 | Yes | No |
