The Swallowing Exercise Aid in Total Laryngectomy: Feasibility, Adherence and a Multidimensional Assessment of Functional-, Physical-, and Patient-reported outcomes

Total laryngectomy (TL), implicating surgical removal of the larynx, is the
operation of choice in patients with advanced laryngeal or hypopharyngeal
cancer. Functional disabilities associated with TL include impairment of
swallowing, speech, olfaction, and taste. Muscle strength, muscle coordination,
and pressure build-up are essential factors for swallowing and
tracheoesophageal speech. Research has shown that TL negatively influences the
patients* pressure build-up at the base of the tongue and coordination of
muscular contraction in the neopharynx. The Swallow Exercise Aid (SEA) is
developed as an exercise tool that activates and strengthens the suprahyoid and
pharyngeal muscles relevant for swallowing function. The feasibility and
adherence were considered good in healthy senior adults and head and neck
cancer patients with chronic dysphagia. Following these positive results, the
feasibility, adherence, and effectiveness of its use for rehabilitation of
swallowing and tracheoesophageal speech will be studied in patients with
altered anatomy because of TL.

The primary objective is to evaluate the feasibility and adherence of 6 weeks
of rehabilitation with the SEA in participants who underwent TL. The secondary
objective is to examine if the SEA is an effective tool to improve swallowing
function and tracheoesophageal speech. The outcomes include functional
(swallowing efficiency, vocal functioning) and physical (intra-pharyngeal
pressure) outcomes, patient-reported complaints, and quality of life.

The proposed study is a pilot study and includes a prospective feasibility
study involving one training group, six weeks of training and three moments of
assessment.

All participants have to train three different strengthening exercises with the
SEA three times a day, including the Chin Tuck against resistance (CTAR+), Jaw
Opening against resistance (JOAR+), and the Effortful swallow exercise (ES+)
for six weeks.

Participating in this study and training with the SEA might improve swallowing
function and voice quality. These improvements may lead to enhance the quality
of life. Muscular pain or muscular exhaustion might be the only risk associated
with participation in this study. The assessments contain radiation and
manometry in which nose bleeding is a minimal risk.