Klaske van Sluis

118 7.2. Materials and Methods was used for the analysis. With a calibrated ergospirometry system (Jaeger Masterscreen CPX, Houten, The Netherlands), connected to the stoma, vital capacity (VC), and forced expiratory volume in the first second (FEV1) were measured. Participants performed a Cardio Pulmonary Exercise Test (CPET) on an electronically braked cycle ergometer (Lode Corival, ProCare, Gronin- gen, The Netherlands). An adapter was made to fit the flow turbine directly to the baseplate in front of the tracheostoma and a headband for fixation was used to support the adapter and flow turbine. The ventilatory efficiency was defined by minute volume of expired air relative to volume of CO 2 produced (VE/VCO 2 ). Patients cycled till they had reached a respiratory exchange ratio of 1.0 thus precluding them from a maximal exertion. Directly after finishing the test, participants were asked to rate their perceived level of exertion and dyspnea on a Borg scale [28, 29]. Voice recordings were made with a head mounted microphone and recorded with Audacity software[30]. Participants were instructed to perform a sustained vowel /a/ as long as possible to mea- sure maximum phonation time (MPT). Vocal range in Herz (Hz) and dynamic range in decibel (dB) were measured as an outcome of the difference between the lowest and highest and softest and loudest /a/ produced, respectively. The best of three attempts was used for each value. All voice recordings were acous- tically analyzed with PRAAT software [31]. Self-reported vocal functioning is assessed with the Voice Handicap Index-10 (VHI-10) [32], self-reported fatigue with the Short Fatigue Questionnaire (SFQ) [33], and self-reported pulmonary functioning with the clinical COPD questionnaire (CCQ)[34]. Table 7.1: Overview of the Assessed Outcome Measures per Time Point, Visu- alization of Period A and B Over Time. Wk0 Wk1 Wk2 Wk3 Wk4 Wk8 Period A Period B Manometry - MEP X X X X X X Spirometry - PEF X X X X X X Spirometry - VC, FEV1 X X CPET—VE/VCO 2 , Borg exertion-, X X Borg dyspnea scale Voice assessment—Vocal range X X X (Hz and dB), MPT Short fatigue questionnaire [33] X X X Clinical COPD Questionnaire [34] X X X Voice Handicap Index-10 [32] X X X Abbreviations: CPET, Cardio Pulmonary Exercise Testing; FEV1, Forced Expiratory Volume in the first second; MEP, Maximum Expiratory Pressure; MPT, Maximum Phonation Time; PEF, Peak Expiratory Flow; VC, Vital Capacity. 7.2.5 Statistical analysis Due to lack of preliminary data with regard to pulmonary exercise programs in TL patients, there was no meaningful way to perform sample size calcula- tions related to the quantitative outcome. All data was analyzed using SPSS