Trials / Completed
CompletedNCT04761380
Decreased Tongue Strength is Related to Skeletal Muscle Mass in COPD Subjects
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 51 (actual)
- Sponsor
- Kindai University · Academic / Other
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Accepted
Summary
Background: Dysphagia is frequently observed in subjects with chronic obstructive pulmonary disease (COPD). But tongue strength has not been investigated yet in COPD subjects. The investigators hypothesized that tongue strength is weaker in COPD subjects compared to normal subjects. Methods: This was a single-centre, observational, and cross-sectional study. Twenty-seven subjects with COPD and twenty-four age-matched control subjects were enrolled in this study. Isometric tongue strength was measured using a device fitted with a disposable oral balloon probe. The investigators also evaluated handgrip strength, gait speed, and appendicular skeletal muscle mass (ASM) to define participants as having sarcopenia. ASM, fat free mass index (FFMI), and skeletal muscle mass index (SMI) were measured by bioelectrical impedance analysis. Gait speed was measured using the 6-meter walking test. The eating assessment test-10 (EAT-10) was used to diagnose dysphagia.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | balloon-based tongue pressure measurement device | The probe was inflated at a baseline pressure of 19.6 kilopascal (kPa). To measure MTP, the balloon was positioned on the anterior palate with the lips closed. Subjects raised their tongue and compressed the balloon onto the palate with maximal voluntary muscular effort for approximately 7s. The measurement was taken three times with a 1-min interval. The maximum value was recorded as the MTP. |
Timeline
- Start date
- 2019-12-01
- Primary completion
- 2020-05-10
- Completion
- 2020-05-10
- First posted
- 2021-02-18
- Last updated
- 2021-02-18
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT04761380. Inclusion in this directory is not an endorsement.