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

NCT ID: NCT04761380

Last Updated: 2021-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-01

Study Completion Date

2020-05-10

Brief Summary

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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

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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stable COPD subjects

balloon-based tongue pressure measurement device

Intervention Type DIAGNOSTIC_TEST

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.

age-matched control subjects subjects who did not have any pulmonary disease

balloon-based tongue pressure measurement device

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Bioelectrical impedance analysis

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kindai University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kindai University Faculty of Medicine

Ōsaka-sayama, Osaka, Japan

Site Status

Countries

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Japan

Other Identifiers

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0414

Identifier Type: -

Identifier Source: org_study_id

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