Swallowing Difficulties in People Over 60 Years: Prevalence, Degree of Difficulty and Intervention

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.

Study Overview

• Status: Recruiting
• Conditions: Dysphagia; Ageing; Intervention
• Intervention / Treatment: Behavioral: Muscular strengthening training; Behavioral: Skill-based training

• Study Type: Interventional
• Enrollment (Estimated): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, 43362
    • Recruiting
    • Sahlgrenska University Hospital
    • Contact: Lisa Tuomi
    • Contact: Lisa Tuomi, PhD; Phone Number: +46 (0)313421000; Email: tuomi.lisa@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Muscular strengthening training; 6 weeks daily muscular strengthening training.
Experimental: 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.	Behavioral: Skill-based training; 15 sessions skill based swallowing training lead by a speech and language pathologist during 3 weeks.
No Intervention: Compensatory treatment; The control group will receive information about dysphagia and advise on compensatory strategies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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.	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
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
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

Collaborators and Investigators

• Sponsor: Lisa Tuomi

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: September 10, 2024
• First Submitted That Met QC Criteria: September 16, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Dysphagia; Health-related quality of life; Age-related dysphagia; Dysphagia intervention; Dysphagia characteristics
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Deglutition Disorders
• Other Study ID Numbers: 2024-00262-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No