Closed: Development of a clinical assessment tool to estimate cardiorespiratory fitness (preoperatively)
Hits: 22
| Trial Status |
Closed
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| Overall study start date |
11-10-2033
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| Overall study end date |
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| Country |
The Netherlands
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| Trial Number |
NL-OMON23304
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| Trial URL |
https://onderzoekmetmensen.nl/en/trial/23304
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| Summary |
The aim of this trial is to develop and validate a questionnaire as a clinical assessment tool for cardiorespiratory fitness (CRF) in several patient groups. The questionnaire we developed consists of three questions about the maximum capacity for walking/running, cycling and stairclimbing. These are recognisable activities for the general Dutch population.
All patients and healthy subjects who are scheduled for a cardiopumonary exercise test (CPET) in the Máxima Medical center are approached for participation in this trial. After receiving signed informed consent and completed questionnaire, the data from the CPET are retrospectively obtained from the electronic patients files.
The results of the questionnaire will be compared with the resultst of the cardiopulmonary exercise test in the same patients. Based on the scores of the questionnaire together with simple demographic characteristics a model will be developed to calculate the maximum oxygen uptake (expressed as VO2peak). Moreover we will conduct analyses to determine whether the FitMáx© is able to estimate preoperative risk for complications during or after surgery. Therefore we will determine cut-off points for VO2peak.
In the same research population existing and validated physical activity questionnaires are used to compare resultst of the FitMáx© questionnaire with. These questionnaires are; the veterans specific activity questionnaire (VSAQ), the duke activity status index (DASI), the physical fitness questions of the EORTC-QLQ C30 and a Metabolic Equivalent of a Task (MET) questionnaire used for preoperative screening in the Netherlands (validation of the preoperative questionnaire was not found in literature).
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| Study Design |
The scores of the FitMáx©, VASQ, DASI, EORTC-QLQ C30 and preoperative MET questionnaire are collected within 42 days from the cardiopulmonary exercise test.
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| Study Setting(s) |
Hospital
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| Study Acronym |
Validation of the FitMáx© questionnaire
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| Study Hypotheses |
FitMáx© questionnaire is a valid clinical assessment tool for CRF compared to the gold standard, a cardiopulmonary exercise test. Moreover we believe the FitMáx© to be fairly accurate in the preoperative risk.
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| Condition |
Healthy, Cardiac, Pulmonary, Oncology, (Cardio)vascular disease
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| Intervention |
No interventions are used in this study. Patient data which is used is collected in the context of standard clinical care.
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| Primary Outcome Measure |
Is the FitMáx© questionnaire a valid instrument to measure cardiorespiratory fitness expressed as VO2-max?
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| Secondary Outcome Measure |
Is the FitMáx© questionnaire a more valid instrument to measure cardiorespiratory fitness compared to existing/validated international questionnaires? - Is the FitMáx© questionnaire without the maximum cycling capacity, still a valid instrument to measure physical fitness? (cultural adaptation for international use) - Is the FitMáx© able to estimate preoperative risk for complications during or after surgery?
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Eligibility
| Participant Type(s) |
Healthy, Cardiac, Pulmonary, Oncology, (Cardio)vascular disease
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| Age Group |
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| Sex |
Both
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| Target Number of Participants |
800
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| Total Final Enrolment |
361
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| Participant Inclusion Criteria |
Patients and healthy subjects who perform a cardiopulmonary exercise test in Máxima Medical Center - Signed informed consent is received
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| Participant Exclusion Criteria |
Patients younger than 18 years - Submaximal exercise test due to early abortion of the test - Incomplete questionnaire
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