Condition category
Not Applicable
Date applied
14/02/2006
Date assigned
14/02/2006
Last edited
03/07/2009
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 G. Schep

ORCID ID

Contact details

Maxima Medisch Centrum
Dept. Sportgeneeskunde
Postbus 7777
Veldhoven
5500 MB
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR526

Study information

Scientific title

Acronym

Study hypothesis

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

Received from the local medical ethics committee

Study design

Randomised active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Diagnostic

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Improvement of sensitivity and specificity of diagnostic tools in diagnosing sports related flow limitations of the iliac arteries

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/09/2005

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Athletes/patients diagnosed with functional iliac flow limitations and healthy athletes

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

210

Participant exclusion criteria

Does not comply with the above inclusion criteria

Recruitment start date

01/09/2005

Recruitment end date

31/12/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Maxima Medisch Centrum
Veldhoven
5500 MB
Netherlands

Sponsor information

Organisation

Maxima Medical Center (Netherlands)

Sponsor details

P.O. Box 7777
Veldhoven
5500 MB
Netherlands
+31 (0)40 8888000
info@mmc.nl

Sponsor type

Not defined

Website

Funders

Funder type

Not defined

Funder name

Not provided at time of registration

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

Publication citations

Additional files

Editorial Notes