Closed: Test-Retest reliability of the FitMáx© questionnaire

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Trial Status Closed
Overall study start date 11-10-2033
Overall study end date
Country The Netherlands
Trial Number NL-OMON23304
Trial URL https://onderzoekmetmensen.nl/en/trial/23304
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).
Study Design
Study Setting(s)
Study Acronym
Study Hypotheses It is hypothesized that the FitMáx© is reliable in repeated measures, and therefore we expect similar scores when FitMáx© is applied within two weeks.
Condition Healthy, Cardiac, Pulmonary, Oncology
Intervention Is the FitMáx© reliable in repeated measures when applied 2 times within two weeks?
Primary Outcome Measure Is the FitMáx© questionnaire a valid instrument to measure cardiorespiratory fitness expressed as VO2-max?
Secondary Outcome Measure Is the FitMáx© questionnaire a more reliable instrument to estimate physical fitness compared to existing/validated international questionnaires?

Eligibility

Participant Type(s) Healthy, Cardiac, Pulmonary, Oncology
Age Group Adult (18-64), Senior (65+)
Sex Both
Target Number of Participants 140
Total Final Enrolment 140
Participant Inclusion Criteria Patients who are treated in the Máxima Medical Centre (department of cardiology, pulmonology and sports medicine) - Patients or subjects who are aged >18 years - Good command of the Dutch language - No expected change in physical fitness within two weeks from enrollment date
Participant Exclusion Criteria Patients who are treated in another department of the Máxima Medical Centre (apart from the above mentioned departments) - Patients aged