The effectiveness of device-driven Expiratory Muscle Strength Training (EMST) in total laryngectomy patients; A pilot study.

After a total laryngectomy (TL) patients experience problems with speaking,
coughing and mucus clearing due to their altered anatomy. Removal of the larynx
alters airway configuration, redirecting pulmonary airflow through the neck via
a tracheostoma. Air entering the lungs by way of the stoma is not warmed and
humidified by the nose and upper respiratory tract, contributing to increased
mucus production (1, 2). Impaired cough function occurs following TL. Vocal
functioning after TL is an important factor in quality of life outcomes. The
majority of patients who undergo TL rehabilitate their vocal functions by
speaking with a voice prosthesis, also called tracheoesophageal Speech
(TE-speech). In TE-speech pulmonary driven speech is re-established, phonation
length and vocal range is limited in this patient group.
Expiratory muscle strength training (EMST) is a behavioural, device-driven
treatment for improving expiratory pressure generating capacity. Evidence of
its benefits is assessed in a group of healthy elderly, a group with Parkinson
disease and in a group of stroke patients. In this study we would like to
assess the effects of EMST in the population of TL patients.

The main purpose of this study is to examine the effects of expiratory muscle
strength training (EMST) in subjects who have undergone a total laryngectomy.
In this pilot study outcomes in pulmonary function, functional exercise
capacity, vocal functioning and participant*s quality of life will be assessed.

In this prospective randomized case series twelve TL patients from the
Netherlands Cancer Institute will be included. Patients will be randomized in
two groups stratiefied by age, each of six individuals. Both groups start a
four week training period with the EMST-device. One training session per day,
five days a week. A training session contains five sets of five forced
exhalations with EMST-device. After the four week training period group 1 stops
training and hands in the EMST-device. Group 2 continues training at a
maintenance dose for another four weeks. Subjects log their training sessions
in a patient diary. During the study period the patient frequently visits the
hospital to adapt the device. At baseline, after four weeks and after eight
weeks assessments are performed to obtain information about pulmonary function,
functional exercise capacity, voice outcomes and quality of life. By analyzing
the functional outcomes and quelity of life possible benefits of EMST training
is will be assessed.

Group 1 (n=6) Four weeks of EMST-training, four weeks no training.
Group 2 (n=6) Four weeks of EMST-training, four weeks continued training on
maintainence dose.
Both groups perform the first four weeks five training sessions a week, five
sets per training session containing five forced exhalations. The maintainence
dose contains two training sessions a week, five sets per training session
containing five forced ehalations.

No serious adverse events are associated with participation. Test procedures
involve forceful breathing which might cause dizziness or in rare cases
bradycardia. A four to eight week EMST training program has to be performed,
during this period the participant has to fill in a diary. Participants need to
visit the hospital six times during this period of eight weeks for pulmonary
testing, monitoring the training and controlling the device. At three time
points more extensive pulmonary and vocal tests are carried out and the
participant is asked to fill in questionnaires. The treatment device is CE
certified and assessed in different populations, no excessive risks and burden
are mentioned. The burden and risks associated with this device and training
period can be justified because of the fact that the training program might
improve pulmonary functioning, voice and therefore quality of life.