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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04761380
• Other study ID #: 0414
• Status: Completed
• Start date: December 1, 2019
• Est. completion date: May 10, 2020

Study information

• Verified date: February 2021
• Source: Kindai University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: May 10, 2020
• Est. primary completion date: May 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
Japan	Kindai University Faculty of Medicine	Osaka-sayama	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Kindai University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximum tongue pressure	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.	1 day
Secondary	handgrip strength	Handgrip strength was measured three times for the right hand using a grip strength dynamometer and mean values were used.	1 day
Secondary	fat free mass index (FFMI)	FFMI (kg/m^2) was calculated by fat free mass/height^2(m^2).	1 day
Secondary	skeletal muscle mass (SMI)	SMI (kg/m^2) was calculated by skeletal muscle mass /height^2(m^2).	1 day
Secondary	fat free mass	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.	1 day
Secondary	skeletal muscle mass	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.	1 day
Secondary	height		1 day