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
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