Trials / Terminated
TerminatedNCT03975465
EMST and Swallowing in Long-Term Survivors of HNCA
Effects of Expiratory Muscle Strength Training (EMST) on Long-Term Swallowing Dysfunction in Persons With Head and Neck Cancer (HNCA) Post Irradiation (RT)
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- University of Wisconsin, Milwaukee · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is a randomized trial examining the impact of expiratory muscle strength training (EMST) on oral intake, swallowing function, and swallow-related quality of life in persons treated for cancer of the head and neck (HNCA) with radiation therapy or chemoradiotherapy (RT/CRT) at least 5 years previously.
Detailed description
Twenty (20) persons treated for cancer of the head and neck (HNCA) with radiation therapy or chemoradiotherapy (RT/CRT) at least 5 years previously will be randomized to an 8-week program of either EMST only and Standard Care only in order to examine the impact of EMST on swallowing function. The EMST program will consist of 5 sets of 5 breaths, 5 days per week for 8 weeks at 75% of maximum expiratory strength. Patients randomized to the EMST group will use the EMST150 (product name) expiratory muscle strength trainer according to package instructions. Standard Care will include swallowing exercises designed to strengthen muscles that contribute to pharyngeal phase motor events and increase structural range of motion. Subjects will be instructed to practice these exercises following a progressive protocol 5 days per week for 8 weeks. All subjects will be evaluated at baseline and at the completion of their rehabilitation program. Assessment will include measurement of maximum expiratory pressure (MEP), a videofluoroscopic swallow study (VFSS) to objectively document swallow function, administration of swallow-related quality of life (QOL) questionnaires, and documentation of current diet using the International Dysphagia Diet Standardisation Initiative (IDDSI) Drink Levels and Food Levels.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Expiratory Muscle Strength Training | 8 weeks of EMST at 75% maximum expiratory pressure (MEP) |
| BEHAVIORAL | Pharyngeal Muscle Strengthening Exercises | 8 weeks of exercises designed to increase pharyngeal muscle strength for swallowing |
Timeline
- Start date
- 2018-09-10
- Primary completion
- 2024-06-04
- Completion
- 2024-06-04
- First posted
- 2019-06-05
- Last updated
- 2024-12-06
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT03975465. Inclusion in this directory is not an endorsement.