Development, optimalisation and validation of the exercise diagnostics for functional iliac flow limitations in endurance athletes: blood pressure measurement, pedal force measurement and near infrared spectroscopy
| ISRCTN | ISRCTN84883192 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84883192 |
| Protocol serial number | NTR526 |
| Sponsor | Maxima Medical Center (Netherlands) |
| Funder | Not provided at time of registration |
- Submission date
- 14/02/2006
- Registration date
- 14/02/2006
- Last edited
- 03/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr G. Schep
Scientific
Scientific
Maxima Medisch Centrum
Dept. Sportgeneeskunde
Postbus 7777
Veldhoven
5500 MB
Netherlands
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised active controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | The use of a new protocol of exercise testing with use of blood pressure measurement, near infrared spectroscopy and pedal force measurement will improve the diagnostic value of the current decision algorithm used to diagnose functional iliac flow limitations in endurance athletes. |
| Ethics approval(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Functional iliac flow limitations |
| Intervention | Blood pressure measurements, pedal force measurements and near infrared measurements during and after exercise testing in both patients and in healthy test subjects |
| Intervention type | Other |
| Primary outcome measure(s) |
Improvement of sensitivity and specificity of diagnostic tools in diagnosing sports related flow limitations of the iliac arteries |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 210 |
| Key inclusion criteria | Athletes/patients diagnosed with functional iliac flow limitations and healthy athletes |
| Key exclusion criteria | Does not comply with the above inclusion criteria |
| Date of first enrolment | 01/09/2005 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Maxima Medisch Centrum
Veldhoven
5500 MB
Netherlands
5500 MB
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 |
