DysphagiaNCT06599021
Swallowing Difficulties in People Over 60 Years: Prevalence, Degree of Difficulty and Intervention
A study testing Muscular strengthening training and Skill-based training in people with Dysphagia and Intervention, run by Lisa Tuomi at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dysphagia, Intervention, Ageing
- What is being tested?
- Muscular strengthening training and Skill-based training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteSweden
- Study dates
- 1 Dec 2024to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participation in SCAPIS2
- Swallowing dysfunction according to timed water swallow test or
- Swallowing dysfunction according to self-report
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg, 43362
Lisa Tuomi, PhD, +46 (0)313421000, tuomi.lisa@gmail.com
Lisa Tuomi
About this study
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.
- Conditions
- Dysphagia, Intervention, Ageing
- Being tested
- Muscular strengthening training, Skill-based training
- Keywords
- Dysphagia, Age-related dysphagia, Health-related quality of life, Dysphagia intervention, Dysphagia characteristics
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscular strengthening trainingBehavioural
6 weeks daily muscular strengthening training.
Skill-based trainingBehavioural
15 sessions skill based swallowing training lead by a speech and language pathologist during 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Muscular strengthening training |
| 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. Receives: Behavioral: Skill-based training |
| Compensatory treatment | No intervention | The control group will receive information about dysphagia and advise on compensatory strategies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline to post-intervention (6 weeks)
Secondary outcomes (11)
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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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
Measured: Up to 12 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Dec 2024
- Primary completionApr 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lisa Tuomi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lisa Tuomi, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599021
- Sponsor's protocol ID
- 2024-00262-01
- Status last verified
- Apr 2026
- First submitted
- 10 Sep 2024
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swallowing Difficulties in People Over 60 Years: Prevalence, Degree of Difficulty and Intervention
- ClinicalTrials.gov ID
- NCT06599021
- Acronym / sponsor ID
- 2024-00262-01
- Conditions
- Dysphagia, Intervention, Ageing
- Keywords
- Dysphagia, Age-related dysphagia, Health-related quality of life, Dysphagia intervention, Dysphagia characteristics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Lisa TuomiUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Muscular strengthening training | Experimental | Behavioral: Muscular strengthening trainingThe 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 | Experimental | Behavioral: Skill-based trainingDuring 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. |
| Compensatory treatment | No intervention | –The control group will receive information about dysphagia and advise on compensatory strategies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participation in SCAPIS2
- Swallowing dysfunction according to timed water swallow test or
- Swallowing dysfunction according to self-report
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscular strengthening training6 weeks daily muscular strengthening training. | Behavioural | Muscular strengthening training |
| Skill-based training15 sessions skill based swallowing training lead by a speech and language pathologist during 3 weeks. | Behavioural | Skill-based training |
Primary outcome
Penetration-aspiration score (PAS)
Time frame: 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).
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscular strengthening training and Skill-based training in people with Dysphagia and Intervention, run by Lisa Tuomi at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penetration-aspiration score (PAS) (time frame: Baseline to post-intervention (6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.