Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06599021

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

Led by Lisa Tuomi · Updated on 2026-04-27

99

Participants Needed

1

Research Sites

52 weeks

Total Duration

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AI-Summary

What this Trial Is About

Researchers are studying swallowing difficulties (dysphagia) in people over 60 years old to better understand how common these problems are, how severe they can be, and how different treatments might help. This study includes participants from the Swedish Cardio Pulmonary bioimage study (SCAPIS2) who show signs of swallowing difficulty. The goal is to improve how swallowing problems are diagnosed and treated in an aging population. Participants with moderate to severe dysphagia are randomly assigned to one of three groups: one group does muscle strengthening exercises involving "head-ups" performed three times daily for six weeks; another group receives skill-based swallowing training led by a speech and language pathologist over 15 sessions in three weeks, using different foods and drinks to improve swallowing coordination; and a control group receives information and advice on compensatory strategies for swallowing difficulties. During the study, researchers assess swallowing function using a flexible endoscopic evaluation, focusing mainly on the penetration-aspiration score before and after the six-week intervention. Secondary outcomes include symptoms related to dysphagia, tongue strength, body composition, costs of intervention, self-perceived swallowing ability, and quality of life measures up to 12 months after intervention. Participants complete questionnaires and undergo various assessments to monitor swallowing efficiency and safety throughout the study period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Participation in SCAPIS2
  • Swallowing dysfunction according to timed water swallow test or self-report
Not Eligible

You will not qualify if you...

  • Severely impaired intellectual abilities
  • Inability to consent to inclusion in the study
  • Inability to answer written questionnaires in Swedish
  • No signs of aspiration, slow swallowing (<10 ml/sec) or self-rated difficulties with eating and swallowing in sub-study SCAPIS2 (for control cohort)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 3 to 6 weeks depending on assigned intervention

Participants receive either muscular strengthening training daily for 6 weeks, skill-based swallowing training during 15 sessions over 3 weeks, or compensatory treatment with advice on dysphagia management.

15 in-person training sessions over 3 weeks or daily exercises for 6 weeks

Follow-up

Duration - Up to 12 months post-intervention

Participants are monitored for up to 12 months after the intervention to assess swallowing function, symptoms, strength, body composition, and quality of life.

Trial Site Locations

Total: 1 location

1

Sahlgrenska University Hospital

Gothenburg, Sweden, 43362

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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