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

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Diagnostic Test: balloon-based tongue pressure measurement device

• Registration Number: NCT04761380
• Lead Sponsor: Kindai University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-01
• Primary Completion: 2020-05-10
• Study Completion: 2020-05-10
• Study First Submitted: 2020-10-09
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-17
• Last Update Submitted: 2021-02-17
• Study First Posted: 2021-02-18
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
age-matched control subjects subjects who did not have any pulmonary disease	balloon-based tongue pressure measurement device	-
stable COPD subjects	balloon-based tongue pressure measurement device	-

Primary Outcome Measures

Name	Time	Method
maximum tongue pressure	1 day	To 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 Outcome Measures

Name	Time	Method
height	1 day
fat free mass index (FFMI)	1 day	FFMI (kg/m\^2) was calculated by fat free mass／height\^2(m\^2).
skeletal muscle mass	1 day	Skeletal 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.
handgrip strength	1 day	Handgrip strength was measured three times for the right hand using a grip strength dynamometer and mean values were used.
skeletal muscle mass (SMI)	1 day	SMI (kg/m\^2) was calculated by skeletal muscle mass ／height\^2(m\^2).
fat free mass	1 day	Fat 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.

Trial Locations

Locations (1)

Kindai University Faculty of Medicine; 🇯🇵 Ōsaka-sayama, Osaka, Japan