Swallowing Difficulties in People Over 60 Years: Prevalence, Degree of Difficulty and Intervention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLisa Tuomi
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participation in SCAPIS2
Swallowing dysfunction according to timed water swallow test or
Swallowing dysfunction according to self-report
Disqualifiers
Severely impaired intellectual abilities.
Inability to consent to inclusion in the study.
Inability to answer written questionnaires in Swedish
Trial design
Design model
Parallel
Treatments tested in this trial
Muscular strengthening training
Behavioral6 weeks daily muscular strengthening training.
Skill-based training
Behavioral15 sessions skill based swallowing training lead by a speech and language pathologist during 3 weeks.
Treatment groups
99 Participants
are divided into 3 treatment groupsGroup A: Muscular strengthening trainingExperimental treatment 1 intervention
Group B: Skill-based trainingExperimental treatment 1 intervention
Group C: Compensatory treatmentNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
Baseline to post-intervention (6 weeks)Secondary outcomes
1
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-intervention2
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-intervention3
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-intervention4
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-interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Lisa Tuomi
Lead sponsor
Sahlgrenska University Hospital
Sponsor institution
Source ClinicalTrials.gov