Do healthy adult males, age 4-70 years without cardio- or pulmonary disease reach a higher maximum oxygen uptake at cardiopulmonary exercisetest with the ramp-protocol in comparison to the standard bloc-protocol? P: healthy adult man, age 40 en 70…
ID
Source
Brief title
Condition
- Heart failures
- Muscle disorders
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
maximum oxygen uptake,
Secondary outcome
lactate
Borgscore
Background summary
An screening file research at the Alrijne Hospital Leiden showed that in 2014
in 29% of the cardiopulmonary exercisetests the test is stopped due to fatigue
in the legs, while were still cardiac and pulmonary reserves. The achieved
oxygen uptake was may be not the maximum. Therefore it is possible that a
patient is wrongly rejected for lobectomy.
Cardiopulmonary exercisetest is a stress test with measurement of oxygen
uptake. At Alrijne Hospital Leiden the standaard protocol used is the the
block protocol: a pre-established number of Watts per minute increase, this tax
remains a constant, then the next minute increase follows.
At the ramp-protocol the watts increase constantly,per second, so there is no
peak load on the legs, the exersise is more easy to sustain. The predicted
value is evenly divided over 10 minutes. With the current exercisesystems this
can be set accurately.
Thesis: when the load is increased, but not per minute per second (disaster),
there is no peak load on the leg muscles and the patient may sustain the effort
any longer. The achieved VO2 can therefore be higher. The chance of curative
Lobectomy is increasing.
Hypothesis:
H0: there is no significant difference in maximum oxygen uptake at the
ramp-protocol
HA: there is a significant difference in maximum oxygen uptake at the
ramp-protocol
Study objective
Do healthy adult males, age 4-70 years without cardio- or pulmonary disease
reach a higher maximum oxygen uptake at cardiopulmonary exercisetest with the
ramp-protocol in comparison to the standard bloc-protocol?
P: healthy adult man, age 40 en 70 jaar
I : Ramp-protocol
C: Blok-protocol
O: maxymum oxygen uptake
The results will determine wich protocol will be used at preoperative
cardiopulmonary exercisetests in Alrijne Ziekenhuis Leiden.
If an higher oxygen uptake at rampprotocol is found in this research, an
follow-up RTC research will be planned.
Study design
It is a comparising study, without longitudinal component in a cross-over
design.
The group of subjecst is formed by self-selection. Subjects can respond to a
recruitment ad and there will be actively recruited in the network of
supervising doctor and researcher.
sample size:
It is a pilot study in order to be able to identify a possible trend in the
maximum VO2 at different exercise protocol. For practical reasons, en available
time, space and equipment may 25 healthy men included.
The inclusion criteria are:
• Men
• Age 40-70 years
The exclusion criteria are:
• No cardiac problems
BMI > 25 kg/m2
• No pulmonary problems
• Can not cycling on the bicycle ergometer
• Panic disorders, particularly claustrophobia
Study burden and risks
the subject starts with a consultation at the Physician assistant.
cardiopulmonary exercise test is almost without any risk for healthy persons,
althoug one can feel exhausted afterwards..
incidentely, there may occur some cardial rythm problems and/or shortness of
breath.
at the prickspot may occur an hematoma
subjects time spend for this research will be 120 minutes
Houtlaan 55
Leiden 2334 CK
NL
Houtlaan 55
Leiden 2334 CK
NL
Listed location countries
Age
Inclusion criteria
healthy male adults age 40-70
Exclusion criteria
no pulmonary diseases, no cardial diseases, no panic disorder, able to cycle on ergometer, BMI > 25 kg/m2
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL53762.058.15 |