Participants included in SCAPIS2 (Swedish Cardio Pulmonary bioimage study) are screened regarding swallowing difficulty using a timed water swallow test. Participants who show signs of swallowing difficulty (dysphagia) are included in the present study, which encompasses s flexible endoscopic evaluation of swallowing function (FEES). Participants showing a moderate-severe dysphagia are randomized into one of three intervention groups: muscle strengthening training, skill-based swallowing training and a control group who will receive compensatory treatment. The study is expected to improve diagnostics and treatment of swallowing difficulties in an ageing population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
99
6 weeks daily muscular strengthening training.
15 sessions skill based swallowing training lead by a speech and language pathologist during 3 weeks.
Sahlgrenska University Hospital
Gothenburg, Sweden
RECRUITINGPenetration-aspiration score (PAS)
Ranges from 1-8 where 8 indicates worst possible aspiration score. Swallowing safety measured from Flexible Endoscopic Examination of Swallowing (FEES).
Time frame: Baseline to post-intervention (6 weeks)
Dysphagia related symtoms
Patient reported outcome measurement (PROM) with Swallowing quality of life (Swal-QOL). Measures QOL depending of swallowing difficulty. Consists of 44 items divided into 10 domains and a symtom frequency scale. Scores on each domain is transformed into scores ranging from 0-100, where 100 indicates best possible swallowing QOL. The Swedish version has been fond valid and reliable.
Time frame: Up to 12 months post-intervention
Tongue strength
Anterior and posterior tongue strength during swallowing and maximal effort is measured with the Iowa Oral Performance Instrument (IOPI)
Time frame: Up to 12 months post-intervention
Body composition
Body composition will be measured using Bioelectric impedance analysis (BIA). Provides measures of fat-free mass and fat.
Time frame: Up to 12 months post-intervention
Cost of intervention
Will be provided through hospital records regarding number of hospital visits and in-hospital treatment during 1 year from start of intervention.
Time frame: Up to 12 months post-intervention
Self-perceived swallowing function
Measured with the Swedish Eating assessment tool (ÄT-10). 10 items with scores ranging from 0 to 40, higher scores indicates worse function. Scores above 3 points are considered to identify the prevalence of a swallowing dysfunction.
Time frame: Up to 12 months post-intervention
EQ5D quality of life questionnaire
Measured with the EQ5D 5 L. Each domain is rated on a scale from 1-5 where a higher number indicates lower QOL.
Time frame: Up to 12 months post-intervention
RAND-36 Quality of Life questionnaire
Measured with the RAND-36. Scores range between 0-100, where 100 indicates best possible outcome.
Time frame: Up to 12 months post-intervention
Assessment of swallowing efficiency
Measurement of swallowing efficiency will be performed with the validated scale such as Yale oropharyngeal residue scale where scores range between 1-5 (none-severe)
Time frame: Up to 12 months post-intervention
Assessment of secretion
Measurement of swallowing function will be performed with assessment of secretion using a validated eight-point scale assesses secretion severity under the subcategories of location, amount, and response. Assessment is performed in a blinded manner.
Time frame: Up to 12 months post-intervention
Assessment of swallowing initiation
Initiation of swallowing will be assessed in a blinded manner, where initiation will be categorized referring to where te bolus reaches befor swallowing is initiated.
Time frame: Up to 12 months post-intervention
Assessment of overall swallowing function from the FEES
Measurement of swallowing function will be performed with the Swedish tool DIGEST-FEES (Dynamic Imaging Grade of Swallowing Toxicity; FEES = flexible endoscopic evaluation of swallowing). This be utilized to describe the severity of safety, efficiency, and pharyngeal stage overall swallowing impairment on FEES. The tool will be validated for the participant group through comparisons with the other measures of swallowing function. The scale ranges from 0 (normal) to 4=life threatening
Time frame: Up to 12 months post-intervention
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