|- candidate number||14065|
|- NTR Number||NTR3740|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||6-dec-2012|
|- Secondary IDs||P12-30 METC Twente|
|- Public Title||Ambulatory cardiorespiratory fitness estimation.|
|- Scientific Title||Ambulatory cardiorespiratory fitness estimation.|
|- hypothesis||We expect we can estimate VO2max accurately using the relation between heart rate and level of activity measured outside the laboratory setting in comparison to VO2max determined during a maximal bicycle ergometer test.|
|- Healt Condition(s) or Problem(s) studied||Healthy subjects|
|- Inclusion criteria||1. Healthy subjects aged between 40 and 70;|
2. Good understanding and writing of the Dutch or English language.
|- Exclusion criteria||1. Medication use that influences/levels off heart rate (e.g. beat blockers);|
2. Unable to complete a walking and cycling test;
3. Obesity (BMI > 30);
4. Known cardio-vascular problems or a history of cardio-vascular problems;
5. Answering 'ja' on one or more of the PAR-Q questions.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||15-jan-2013|
|- planned closingdate||31-okt-2013|
|- Target number of participants||55|
|- Interventions||1. Bicycle maximal exercise test;|
2. Walking on a treadmill (2 - 6 km/h);
3. Monitoring heart rate and activity level (using an accelerometer) during daily life (6 days).
|- Primary outcome||A model to predict VO2max based on combined heart rate and activity data obtained during daily life activities.|
|- Secondary outcome||N/A|
|- Timepoints||See interventions.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| T.M. Tönis|
|- CONTACT for SCIENTIFIC QUERIES|| T.M. Tönis|
|- Sponsor/Initiator ||Roessingh Research and Development b.v., University of Twente|
(Source(s) of Monetary or Material Support)
|Alpe d’HuZes Foundation|
|- Brief summary||Rationale: |
Cardiorespiratory fitness, most often expressed as VO2max, is an important parameter for setting rehabilitation goals, deciding whether a patient is able to undergo transplantation and/or surgery and for achieving maximal training results. Exercise tests, either sub-maximal or till exhaustion, can be used to obtain a VO2max score. These tests however need expensive specialized equipment and trained personnel to supervise the test. The results are based on one observation which makes it sensitive to secondary factors which are difficult to regulate (e.g. stress responses because of the laboratory environment and the willingness of the subject to keep going until exhaustion). Strict adherence to the test protocol is necessary to obtain valid results. Parameters like heart rate and workload, which can be used to predict cardiorespiratory fitness, can be easily and inexpensively measured outside the laboratory setting, e.g. in the home environment. This study will focus on researching the ability, accuracy and reliability of determining VO2max based on parameters measured in the home environment.
Investigating whether VO2max can be estimated reliable and accurate in the home environment based on a combination of heart rate and level of activity.
The study is a mixture of an observational and a laboratory study. Gold standard VO2max of 55 participants will be determined during a bicycle exercise test until exhaustion. In the laboratory the participants will also walk at several speeds on a treadmill while heart rate and level of activity are monitored. This data is used to improve a model to estimate VO2max. The reliability and applicability of this model for estimating VO2max during daily life will be investigated based on data that is gathered during 6 days of monitoring during daily life.
Healthy human volunteers, aged between 40 and 70.
Main study parameters/endpoints:
The main study parameters are the accuracy, expressed as percentage of explained variance and error of the estimate, and reliability, expressed as the variation between estimates of different monitoring days, of the VO2max score determined from combined heart rate and level of activity measured during daily life activities compared to VO2max determined during the bicycle ergometer test until exhaustion.
|- Main changes (audit trail)|
|- RECORD||6-dec-2012 - 2-mrt-2013|