Klaske van Sluis

Expiratory muscle strength training 119 software [35]. Accordingly, no significance tests were performed. Group means were estimated with a 95% confidence interval, using single sample t-tests. 7.3 Results Ten participants were included and signed informed consent. Participants age ranged from 50-73 years, and all were tracheo-esophageal speakers (character- istics are presented in 7.2). Table 7.2: Participant Characteristics. Tracheo Esophageal Time Speech: Randomization Group Parti- Age in since TL Timing Flap Neck Manually/Hands Free 1 = Stop Training cipant Years in Years Radiotherapy Reconstruction Dissection Device 2 = Continue Training 1 65 13 Post-surgery No Both sides Freehands 2 2 67 18 Pre-surgery Unknown † Unknown † Manually 1 3 50 3 Pre-surgery No Both sides Both, alternating 1 4 68 1 Pre-surgery PM-flap No Manually 2 5 57 15 Pre-surgery No Both sides Freehands 1 6 63 7 Pre-surgery No No Manually 2 7 68 3 Pre-surgery No Both sides Both, alternating 1 8 57 10 Post-surgery No Both sides Freehands 2 9 78 3 Post-surgery No Left side Manually 1 10 73 20 Pre-surgery Unknown † Unknown † Manually 2 Abbreviations: PM-flap, Pectoralis Major flap; TL, total laryngectomy. † No surgical information was available. 7.3.1 Feasibility, safety, and compliance Using the EMST device with help of an adapter on the tracheostoma of the TL participants appeared to be generally feasible. All participants could per- form the training. One participant withdrew from the study after one week due to unrelated medical reasons. For the remaining nine participants, compli- ance to the allocated training program was 95.5%. According to the final short questionnaire, participants did not experience problems to stay motivated dur- ing the training weeks. Minor problems included leakage of air underneath the adhesive, which was reported by four of the participants.Two participants occasionally experienced dizziness during and shortly after the training. Three participants were not able to plug the voice prosthesis prior to the training, and continued training without plug. From the six participants who did plug their voice prosthesis before training, three mentioned that plugging was a hassle. Regarding to safety, one adverse event occurred with one of the participants in his fourth EMST training week. After a training session with the EMST, the voice prosthesis was not in situ anymore. A new voice prosthesis was placed and an X-thorax was made which showed that the voice prosthesis was not in the lungs. All participants and the medical ethical review committee were informed.