Ageing, Dysphagia, Intervention
Conditions
Keywords
Dysphagia, Age-related dysphagia, Health-related quality of life, Dysphagia intervention, Dysphagia characteristics
Brief summary
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.
Interventions
BEHAVIORALMuscular strengthening training
6 weeks daily muscular strengthening training.
BEHAVIORALSkill-based training
15 sessions skill based swallowing training lead by a speech and language pathologist during 3 weeks.
Sponsors
Lisa Tuomi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participation in SCAPIS2 * Swallowing dysfunction according to timed water swallow test or * Swallowing dysfunction according to self-report
Exclusion criteria
* Severely impaired intellectual abilities. * Inability to consent to inclusion in the study. * Inability to answer written questionnaires in Swedish Inclusion of non-dysphagia control cohort: No signs of aspiration, slow swallowing (\<10 ml/sec) or self-rated difficulties with eating and swallowing in sub-study SCAPIS2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Penetration-aspiration score (PAS) | Baseline to post-intervention (6 weeks) | Ranges from 1-8 where 8 indicates worst possible aspiration score. Swallowing safety measured from Flexible Endoscopic Examination of Swallowing (FEES). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dysphagia related symtoms | Up to 12 months post-intervention | 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. |
| Tongue strength | Up to 12 months post-intervention | Anterior and posterior tongue strength during swallowing and maximal effort is measured with the Iowa Oral Performance Instrument (IOPI) |
| Body composition | Up to 12 months post-intervention | Body composition will be measured using Bioelectric impedance analysis (BIA). Provides measures of fat-free mass and fat. |
| Cost of intervention | Up to 12 months post-intervention | Will be provided through hospital records regarding number of hospital visits and in-hospital treatment during 1 year from start of intervention. |
| Self-perceived swallowing function | Up to 12 months post-intervention | 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. |
| EQ5D quality of life questionnaire | Up to 12 months post-intervention | Measured with the EQ5D 5 L. Each domain is rated on a scale from 1-5 where a higher number indicates lower QOL. |
| RAND-36 Quality of Life questionnaire | Up to 12 months post-intervention | Measured with the RAND-36. Scores range between 0-100, where 100 indicates best possible outcome. |
| Assessment of swallowing efficiency | Up to 12 months post-intervention | 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) |
| Assessment of secretion | Up to 12 months post-intervention | 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. |
| Assessment of swallowing initiation | Up to 12 months post-intervention | 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. |
| Assessment of overall swallowing function from the FEES | Up to 12 months post-intervention | 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 |
Countries
Sweden
Outcome results
None listed