NCT06599021

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
24mo left

Started Dec 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress43%
Dec 2024Apr 2028

First Submitted

Initial submission to the registry

September 10, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

2.3 years

First QC Date

September 10, 2024

Last Update Submit

April 22, 2026

Conditions

DysphagiaInterventionAgeing

Keywords

DysphagiaAge-related dysphagiaHealth-related quality of lifeDysphagia interventionDysphagia characteristics

Outcome Measures

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).

    Baseline to post-intervention (6 weeks)

Secondary Outcomes (11)

  • Dysphagia related symtoms

    Up to 12 months post-intervention

  • Tongue strength

    Up to 12 months post-intervention

  • Body composition

    Up to 12 months post-intervention

  • Cost of intervention

    Up to 12 months post-intervention

  • Self-perceived swallowing function

    Up to 12 months post-intervention

  • +6 more secondary outcomes

Study Arms (3)

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.

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.

Behavioral: Skill-based training

Compensatory treatment

NO INTERVENTION

The control group will receive information about dysphagia and advise on compensatory strategies.

Interventions

Muscular strengthening trainingBEHAVIORAL

6 weeks daily muscular strengthening training.

Muscular strengthening training
Skill-based trainingBEHAVIORAL

15 sessions skill based swallowing training lead by a speech and language pathologist during 3 weeks.

Skill-based training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participation in SCAPIS2
  • Swallowing dysfunction according to timed water swallow test or
  • Swallowing dysfunction according to self-report

You may not qualify if:

  • Severely impaired intellectual abilities.
  • Inability to answer written questionnaires in Swedish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 43362, Sweden

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Speech-language pathologist, associate professor

Study Record Dates

First Submitted

September 10, 2024

First Posted

September 19, 2024

Study Start

December 1, 2024

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2028

Last Updated

April 27, 2026

Record last verified: 2026-04

Locations

SE(1)