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 |
| Protocol serial number | 04/331-k (METC UMCU) |
| Sponsor | University Medical Centre Utrecht (UMCU) (Netherlands) |
| Funders | Johanna Child Fund (Johanna Kinderfonds) (The Netherlands), Foundation for paediatric rehabilitation (Stichting Bio-Kinderrevalidatie) (The Netherlands) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre, randomised, single-blinded, active controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Exercise capacity and muscle strength. |
| Key secondary outcome measure(s) |
Health related quality of life. |
| Completion date | 02/08/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 8 Years |
| Upper age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
