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Decreased Tongue Strength is Related to Skeletal Muscle Mass in COPD Subjects

Decreased Tongue Strength is Related to Skeletal Muscle Mass in COPD Subjects

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04761380
Enrollment
51
Registered
2021-02-18
Start date
2019-12-01
Completion date
2020-05-10
Last updated
2021-02-18

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

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

dysphagia

Brief 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.

Interventions

DIAGNOSTIC_TESTballoon-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.

Sponsors

Kindai University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Clinical diagnosis of stable COPD. * Age-matched control subjects who did not have any pulmonary disease.

Exclusion criteria

* Participants with metallic implants. * History of stroke disease. * History of neuromuscular disease. * Participants who did not have their front teeth.

Design outcomes

Primary

MeasureTime frameDescription
maximum tongue pressure1 dayTo measure maximum tongue pressure (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.

Secondary

MeasureTime frameDescription
fat free mass index (FFMI)1 dayFFMI (kg/m\^2) was calculated by fat free mass/height\^2(m\^2).
skeletal muscle mass (SMI)1 daySMI (kg/m\^2) was calculated by skeletal muscle mass /height\^2(m\^2).
handgrip strength1 dayHandgrip strength was measured three times for the right hand using a grip strength dynamometer and mean values were used.
skeletal muscle mass1 daySkeletal muscle mass was measured using the medical body composition analyzer. It is designed for measurements in the supine position, using four pairs of electrodes (eight electrodes in total), positioned on each hand and foot21. Supine measurements were taken after lying down for 10 minutes. Alcohol was prohibited for 24h prior to the impedance measurements.
height1 day
fat free mass1 dayFat free mass was measured using the medical body composition analyzer. It is designed for measurements in the supine position, using four pairs of electrodes (eight electrodes in total), positioned on each hand and foot21. Supine measurements were taken after lying down for 10 minutes. Alcohol was prohibited for 24h prior to the impedance measurements.

Countries

Japan

Outcome results

None listed

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