Klaske van Sluis

Expiratory muscle strength training 117 and subsequent adjustment of the pressure of the EMST device were performed at baseline and after each training week. Participants were instructed to per- form their training sessions at home and log every training and details in a diary to check compliance. During the weekly visits to the hospital the researchers monitored the participants’ compliance by discussing their training results. The pressure of the device was set at approximately 80% of the participant’s mean Maximum Expiratory Pressure (MEP). In the following four weeks (period B), participants were allocated to different protocols depending on the group they were randomized to. Participants in group 1 discontinued the training. Partic- ipants in group 2 continued EMST for another four weeks, but with a lower frequency of two days per week. Block-randomization in blocks of four with stratification for age was performed with help of Alea software. Adjustments in training procedures with the EMST150 device were needed. Before each training session, the participants’ voice prosthesis had to be blocked with a plug to avoid air escaping through the voice prosthesis into the esopha- gus. Participants were instructed to connect the EMST device at the adhesive in front of the tracheostoma, take a deep breath, close the opening on top of the adaptor with a finger, and exhale forcefully into the EMST device until enough pressure was built up to open the valve inside. 7.2.3 Feasibility, safety, and compliance The main objective of the study was to evaluate feasibility, safety, and com- pliance with the EMST program. Any difficulties regarding participants’ per- formance of the training and assessment procedures were documented. Partic- ipants were instructed to log every training session and reflect on their expe- riences in a diary. At the end of the training program participants filled in a short questionnaire on whether they found the training feasible and whether they could stay motivated during the period of training. 7.2.4 Objective and subjective outcome measures The effects of EMST on pulmonary function, physical exertion, fatigue, and vocal functioning are assessed with manometry, spirometry, cardio pulmonary exercise testing (CPET), voice recordings, and questionnaires. Time points of the assessments are shown in Table 7.1. MEP in cmH 2 O was obtained with a calibrated digital manometer (Druck DPI 705) connected to the adapter whilst the EMST device was adjusted to the maximum pressure of 150 cmH 2 O and connected to the tracheostoma. Participants were instructed to sit, take a deep breath, occlude the adapter and exhale as forcefully as possible. Peak Expiratory Flow (PEF) in L/min was obtained with a Micro l spirometer com- bined with a Microgard ll filter (PT Medical) which was placed directly on the baseplate of the stoma. Participants were instructed to inhale calm but deep and then exhale as forcefully and fast as they could. A series of three forced expirations was used to obtain MEP and PEF, the mean of the three trials