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

NCT ID: NCT06599021

Last Updated: 2024-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2028-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Dysphagia Intervention Ageing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Muscular strengthening training

Intervention Type BEHAVIORAL

6 weeks daily muscular strengthening training.

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.

Group Type EXPERIMENTAL

Skill-based training

Intervention Type BEHAVIORAL

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

Compensatory treatment

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Muscular strengthening training

6 weeks daily muscular strengthening training.

Intervention Type BEHAVIORAL

Skill-based training

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lisa Tuomi

OTHER

Sponsor Role lead

Responsible Party

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Lisa Tuomi

Speech-language pathologist, associate professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status RECRUITING

Countries

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Sweden

Facility Contacts

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Lisa Tuomi, PhD

Role: primary

+46 (0)313421000

Lisa Tuomi

Role: backup

Other Identifiers

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2024-00262-01

Identifier Type: -

Identifier Source: org_study_id