DysphagiaNCT04402307

Effect of Training of Patients With Dysphagia

A study testing Chin Tuck Against Resistance in people with Dysphagia, run by Regionshospital Nordjylland at 8 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Effect of training of patients with dysphagia Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dysphagia
What is being tested?: Chin Tuck Against Resistance
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 93 participants
Where: 8 sitesDenmark
Study dates: 25 Mar 2019to 31 Dec 2020
Phase: Interventional
Are there results?: None posted in the registry

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
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients diagnosed with dysphaigia
Patients living in the participating locations

Who cannot join

Patients who are linguistically or cognitively unable to participate
Patients who are unable to collaborate about the training
Palliative patients
Patients with a probe

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

Denmark8 sites

Brøndby municipality
Brøndby, 2605
Jammerbugt municipality
Brovst, 9460
Frederikshavn municipality
Frederikshavn, 9900
Hjørring municipality
Hjørring, 9800
Kolding municipality
Kolding, 6000
Odense municipality
Odense, 5100
Slagelse municipality
Slagelse, 4200
Tønder municipality
Tønder, 6270

Other trials in Denmark

About this study

Effect of training of patients with dysphagia

Read the detailed description

A randomised controlled study in the effect of training in patients with dysphagia.

The patients are randomised for training or for usual care.

Conditions: Dysphagia
Being tested: Chin Tuck Against Resistance
Keywords: Training, Effect, Elderly
Medical subject headings: Deglutition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Chin Tuck Against ResistanceOther
Training in 6 weeks 3 times a day.

Study groups in NCT04402307
Study group	Role	What they receive
Usual care	No intervention	Usual care to patients with dysphagia
Training	Experimental	Chin Tuck Against Resistance to patients with dysphagia Receives: Other: Chin Tuck Against Resistance

What is being measured

The primary outcome is the main question the study is designed to answer.

Readmission
Number of readmissions within 6 months
Measured: 6 months

Secondary outcomes (4)

Change in Quality of life
Level of quality of life - measured with Dysphagia Handicap Index questionnaire
Measured: 3 months
Cost effectiveness
Economic evaluation of training compared to usual care, measured with EQ-5D
Measured: 6 months
Mortality
Mortality in patients with dysphagia within 6 months
Measured: 6 months
Swallowing function
Aspiration (yes/no) - measured with Volume Viscosity Swallow Test
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Mar 201931 Dec 2020

First posted26 May 2020
Study start25 Mar 2019
Primary completion31 Dec 2020
Study completion31 Dec 2020

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: 93 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04402307
Sponsor's protocol ID: RHN_DMK_05
Status last verified: Oct 2021
First submitted: 1 Apr 2019
Last updated: 13 Oct 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dysphagia trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Training of Patients With Dysphagia
ClinicalTrials.gov ID: NCT04402307
Acronym / sponsor ID: RHN_DMK_05
Conditions: Dysphagia
Keywords: Training, Effect, Elderly
Study type: Interventional
Recruitment status: Completed
Enrolment: 93 participants (actual)
Lead sponsor: Regionshospital NordjyllandOther government
Study start: 25 Mar 2019 (actual)
Primary completion: 31 Dec 2020 (actual)
Study completion: 31 Dec 2020 (actual)
First posted: 26 May 2020 (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.

Effect of training of patients with dysphagia

Detailed description

A randomised controlled study in the effect of training in patients with dysphagia.

The patients are randomised for training or for usual care.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Usual care	No intervention	–Usual care to patients with dysphagia
Training	Experimental	Other: Chin Tuck Against ResistanceChin Tuck Against Resistance to patients with dysphagia

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients diagnosed with dysphaigia
Patients living in the participating locations

Key exclusion criteria (4 listed)

Patients who are linguistically or cognitively unable to participate
Patients who are unable to collaborate about the training
Palliative patients
Patients with a probe

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
Chin Tuck Against ResistanceTraining in 6 weeks 3 times a day.	Other	Training

Primary outcome

Readmission
Time frame: 6 months
Number of readmissions within 6 months

4 secondary outcomes

Change in Quality of life
Time frame: 3 months
Cost effectiveness
Time frame: 6 months
Mortality
Time frame: 6 months
Swallowing function
Time frame: 3 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.

Related trials for Dysphagia

RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Recruiting
taVNS in Infants Severe Dysphagia
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Active, not recruitingObservational study
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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. This study is not recruiting at the moment.

Dorte M Kristiansen, PhD principal investigator

Regionshospital Nordjylland

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Chin Tuck Against Resistance in people with Dysphagia, run by Regionshospital Nordjylland at 8 sites in Denmark.

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 2 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: finished, as of the sponsor's last update on 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Denmark. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Readmission (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04402307.

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 13 Oct 2021.