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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Muscular strengthening training | Experimental | The muscular strengthening training is permformed 3 times daily as "head-ups" where the participant lies down and lifts their head anf then holds it upright during 60 seconds. This is repeated x 3 followed by 30 head-lifts. The duration of the training programme is 6 weeks. |
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| Skill-based training | Experimental | During the skill-based training programme, food and beverages are used as swallowing training material based on a pre-determined food-hierarchy. The training starts at the highest level that the participant can safely swallow and then progresses as strength and coordination of swallowing improves. This training is comprised of 15 speech- and language pathologist lead training sessions during 3 weeks. |
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| Compensatory treatment | No Intervention | The control group will receive information about dysphagia and advise on compensatory strategies. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Muscular strengthening training | Behavioral | 6 weeks daily muscular strengthening training. |
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| Measure | Description | Time Frame |
|---|---|---|
| Penetration-aspiration score (PAS) | Ranges from 1-8 where 8 indicates worst possible aspiration score. Swallowing safety measured from Flexible Endoscopic Examination of Swallowing (FEES). | Baseline to post-intervention (6 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University Hospital | Recruiting | Gothenburg | 43362 | Sweden |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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| Skill-based training | Behavioral | 15 sessions skill based swallowing training lead by a speech and language pathologist during 3 weeks. |
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| 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) | 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. | 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. | 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. | 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. | 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. | 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) | 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. | 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. | 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 | Up to 12 months post-intervention |
| D010038 | Otorhinolaryngologic Diseases |