Swallowing Difficulties in People Over 60 Years: Prevalence, Degree of Difficulty and Intervention
- Conditions
- DysphagiaInterventionAgeing
- Interventions
- Behavioral: Muscular strengthening trainingBehavioral: Skill-based training
- Registration Number
- NCT06599021
- Lead Sponsor
- Lisa Tuomi
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 99
- Participation in SCAPIS2
- Swallowing dysfunction according to timed water swallow test or
- Swallowing dysfunction according to self-report
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Muscular strengthening training Muscular strengthening training 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. Skill-based training Skill-based training 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Quality of Life 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
Trial Locations
- Locations (1)
Sahlgrenska University Hospital
🇸🇪Gothenburg, Sweden