Condition category
Not Applicable
Date applied
14/02/2006
Date assigned
14/02/2006
Last edited
05/11/2008
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 W van der Weegen

ORCID ID

Contact details

St Anna Zorggroep
P.O. Box 90
Geldrop
5660 AB
Netherlands
wvdweegen@tiscali.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR536

Study information

Scientific title

Acronym

Study hypothesis

If the 'level of fitness dependant protocol' produces a higher VO2-max in comparison with the adapted Bruce protocol, then a relevant difference can be shown when the results are statistically analysed.

Ethics approval

Received from the local medical ethics committee

Study design

Randomised, double blind, controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

Accuracy of a 'level of fitness dependent protocol'

Intervention

Subjects will do both exercise tests with a minimum of one week and a maximum of 3 weeks in between. Which test is taken first is decided by means of chance.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The maximum VO2 of both tests taken.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

13/12/2005

Overall trial end date

01/05/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 20 - 65 years of age
2. Healthy subjects

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

72

Participant exclusion criteria

1. Use of medication concerning blood pressure or heart
2. Smoking subjects
3. Younger than 20 or older than 65 years
4. Musculoskeletal disorders which affect maximal bicycle ergometry

Recruitment start date

13/12/2005

Recruitment end date

01/05/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

St Anna Zorggroep
Geldrop
5660 AB
Netherlands

Sponsor information

Organisation

St Anna Caregroup (St Anna Zorggroep) (The Netherlands)

Sponsor details

Department of Sports and Medicine
P.O. Box 90
Geldrop
5660 AB
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

St Anna Caregroup (St Anna Zorggroep) (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

Publication citations

Additional files

Editorial Notes