Resistance Swallowing Training in Patients With Tracheotomy

April 15, 2024 updated by: Shanghai Zhongshan Hospital

Effect of Early Progressive Resistance Swallowing Training on Swallowing Related Muscle Strength in Patients With Tracheotomy

The goal of this clinical trial is to learn investigate the effect of instrument-assisted early progressive resistance swallowing training on swallowing related muscle strength in critically ill patients. It will also learn about the safety of swallowing training. The main questions it aims to answer are:

  • Does instrument-assisted early progressive resistance swallowing training increase the swallowing related muscle strength in critically ill patients?
  • What medical problems do participants have when taking swallowing training?

Researchers will compare instrument-assisted early progressive resistance swallowing training to pure effortful swallowing to see if instrument-assisted early progressive resistance swallowing training works to increase muscle strength.

Participants will:

-Take instrument-assisted early progressive resistance swallowing training or pure effortful swallowing every day for 2 weeks and take muscle strength test every week.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged ≥ 18 years old
  • Tracheotomy after intubation and ventilator ventilation
  • Receiving treatment in ICU, and expected hospital stay > 2 weeks after pneumonectomy
  • Be able to cooperate to complete the maximum anterior tongue pressure test

Exclusion Criteria:

  • Inability to cooperate with tongue pressure testing and swallowing training, including disturbance of consciousness, oropharyngeal neuromuscular or motor impairment
  • Patients refuse to participate in this study
  • Significant malocclusion and facial asymmetry

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
Other: pure effortful swallowing
The investigator instructed the patient to "swallow forcefully while squeezing the tongue upward and backward in the direction of the soft palate" based on the sounds of an electronic timer.
Experimental: Test group
Other: progressive resistance swallowing training
Patients in the test group, resistance swallowing exercise was performed by providing external resistance through Iowa Oral Performance Instrument (IOPI), and all other protocols were performed the same as those in the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forced swallowing tongue pressure
Time Frame: Day 14 after training
Place the pressure balloon on the prelingual pressure measurement site. The examiner placed the water in the participant 's mouth using a disposable 3 mL syringe. Subjects held 3 mL of water in their mouth and swallowed as forcefully as possible as directed by the examiner to observe instrument readings.
Day 14 after training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 15, 2024

First Submitted That Met QC Criteria

April 15, 2024

First Posted (Actual)

April 18, 2024

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • KY2023635

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Swallowing Training on Muscle Strength

Clinical Trials on pure effortful swallowing

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe