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Resistance Swallowing Training in Patients With Tracheotomy

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06372795
Enrollment
66
Registered
2024-04-18
Start date
2024-05-01
Completion date
2026-12-31
Last updated
2024-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Swallowing Training on Muscle Strength

Brief summary

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.

Interventions

OTHERpure 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.

OTHERprogressive 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.

Sponsors

Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Forced swallowing tongue pressureDay 14 after trainingPlace 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026