Swallowing Difficulties in People Over 60 Years: Prevalence, Degree of Difficulty and Intervention
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Muscular strengthening training, Skill-based training.
- Who it may be relevant to
- Registry conditions: Dysphagia, Intervention, Ageing. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Behavioral Muscular strengthening training
6 weeks daily muscular strengthening training. - Behavioral Skill-based training
15 sessions skill based swallowing training lead by a speech and language pathologist during 3 weeks.
Primary outcome measures
- Penetration-aspiration score (PAS) [Time frame: Baseline to post-intervention (6 weeks)]
Secondary outcome measures (11)
- Dysphagia related symtoms [Time frame: Up to 12 months post-intervention]
- Tongue strength [Time frame: Up to 12 months post-intervention]
- Body composition [Time frame: Up to 12 months post-intervention]
- Cost of intervention [Time frame: Up to 12 months post-intervention]
- Self-perceived swallowing function [Time frame: Up to 12 months post-intervention]
- EQ5D quality of life questionnaire [Time frame: Up to 12 months post-intervention]
- RAND-36 Quality of Life questionnaire [Time frame: Up to 12 months post-intervention]
- Assessment of swallowing efficiency [Time frame: Up to 12 months post-intervention]
- Assessment of secretion [Time frame: Up to 12 months post-intervention]
- Assessment of swallowing initiation [Time frame: Up to 12 months post-intervention]
- Assessment of overall swallowing function from the FEES [Time frame: Up to 12 months post-intervention]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Sahlgrenska University Hospital — Gothenburg
Identifiers
NCT: NCT06599021 · 2024-00262-01